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Trial record 8 of 26 for:    "Bacterial Conjunctivitis" | "Anti-Bacterial Agents"

Safety and Efficacy of PRO-157 vs Moxifloxacin vs Gatifloxacin in Patients With Bacterial Conjunctivitis (Pazufloxacin) (Pazufloxacin)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02980523
Recruitment Status : Completed
First Posted : December 2, 2016
Results First Posted : February 15, 2019
Last Update Posted : May 22, 2019
Sponsor:
Information provided by (Responsible Party):
Laboratorios Sophia S.A de C.V.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Bacterial Conjunctivitis
Interventions Drug: PRO-157
Drug: Vigamox
Drug: Zymar®
Drug: Lagricel Ofteno®
Enrollment 150
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PRO-157 BID (2 Times Per Day) PRO-157 TID (3 Times Per Day) PRO-157 QID (4 Times Per Day) Moxifloxacin (Vigamox®) Gatifloxacin (Zymar®)
Hide Arm/Group Description

60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen:

  1. instill one drop in each eye of PRO-157 (pazufloxacin), every 12 hours per day (BID), for 7 days
  2. instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%)every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)

PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution

Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution

60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen:

  1. instill one drop in each eye of PRO-157 (pazufloxacin), every 8 hours per day (TID), for 7 days
  2. 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)

PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution

Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution

60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen:

  1. instill one drop in each eye of PRO-157 (pazufloxacin), every 6 hours per day (QID), for 7 days
  2. 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)

PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution

Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution

60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen:

  1. instill one drop in each eye of Moxifloxacin, every 8 hours per day, for 7 days.
  2. 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day for 7 days. (Can be applied 15 minutes after moxifloxacin)

Vigamox: Vigamox® (Moxifloxacin 0.5%), Alcon Laboratories, S.A. de C.V., ophthalmic solution

Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution

60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen:

  1. instill one drop in each eye of Gatifloxacin, every 8 hours per day, for 7 days.
  2. 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day for 7 days.one drop 4 times a day for 7 days in each eye.(Can be applied 15 minutes after gatifloxacin)

Zymar®: Zymar® (Gatifloxacin 0.3%), Allergan, S.A. de C.V., ophthalmic solution

Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution

Period Title: Overall Study
Number of participants Number of units (eyes) Number of participants Number of units (eyes) Number of participants Number of units (eyes) Number of participants Number of units (eyes) Number of participants Number of units (eyes)
Started 30 60 30 60 30 60 30 60 30 60
Completed 27 54 19 38 24 48 21 42 20 40
Not Completed 3 6 11 22 6 12 9 18 10 20
Reason Not Completed
Lost to Follow-up             1                         4                         1                         2                         1            
Excluded from analysis             1                         3                         1                         1                         1            
Lack of Efficacy             1                         4                         4                         5                         8            
Did not receive intervention             0                         0                         0                         1                         0            
Arm/Group Title PRO-157 BID PRO-157 TID PRO-157 QID Moxifloxacine Gatifloxacine Total
Hide Arm/Group Description One drop twice a day for 7 days (PRO-157=pazufloxacin 0.6%) One drop three times a day for 7 days (PRO-157=pazufloxacin 0.6%) One drop three times a day for 7 days (PRO-157=pazufloxacin 0.6%) One drop four times a day for 7 days Moxifloxacin 0.5% (Vigamox®). One drop four times a day for 7 days Gatifloxacin 0.3% (Zymar®). Total of all reporting groups
Overall Number of Baseline Participants 27 19 24 21 20 111
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
54 38 48 42 40 222
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 19 participants 24 participants 21 participants 20 participants 111 participants
<=18 years
7
  25.9%
3
  15.8%
7
  29.2%
5
  23.8%
5
  25.0%
27
  24.3%
Between 18 and 65 years
11
  40.7%
13
  68.4%
10
  41.7%
11
  52.4%
8
  40.0%
53
  47.7%
>=65 years
9
  33.3%
3
  15.8%
7
  29.2%
5
  23.8%
7
  35.0%
31
  27.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants 19 participants 24 participants 21 participants 20 participants 111 participants
41.1  (27.9) 37.2  (21.3) 43.3  (25.7) 39.9  (26.9) 43.4  (29.5) 40.8  (26.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 19 participants 24 participants 21 participants 20 participants 111 participants
Female
19
  70.4%
10
  52.6%
16
  66.7%
13
  61.9%
11
  55.0%
69
  62.2%
Male
8
  29.6%
9
  47.4%
8
  33.3%
8
  38.1%
9
  45.0%
42
  37.8%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Mexico Number Analyzed 27 participants 19 participants 24 participants 21 participants 20 participants 111 participants
Mexicans
27
 100.0%
19
 100.0%
24
 100.0%
21
 100.0%
20
 100.0%
111
 100.0%
others
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Change From Baseline Bacterial Culture
Hide Description

Efficacy will be determined comparing the cultures of the lower conjunctival pouch, of the baseline (day 1) against final visit (day 8), quantifying and identifying the colony forming units (CFU) by genus and species.

The evaluated variable is discrete quantitative type and the scale of measurement used will be CFU x mL considering the eradication, reduction or proliferation of the bacterial agent. It will be determined as effective if there is a reduction in number of bacterial flora in at least 95% of the evaluated subjects.

Time Frame up to one week
Hide Outcome Measure Data
Hide Analysis Population Description
Treatment analysis, a culture was performed per eye
Arm/Group Title PRO-157 BID (2 Times Per Day) PRO-157 TID (3 Times Per Day) PRO-157 QID (4 Times Per Day) Moxifloxacin (Vigamox®) Gatifloxacin (Zymar®)
Hide Arm/Group Description:

60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen:

  1. instill one drop in each eye of PRO-157 (pazufloxacin), every 12 hours per day (BID), for 7 days
  2. instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%)every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)

PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution

Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution

60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen:

  1. instill one drop in each eye of PRO-157 (pazufloxacin), every 8 hours per day (TID), for 7 days
  2. 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)

PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution

Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution

60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen:

  1. instill one drop in each eye of PRO-157 (pazufloxacin), every 6 hours per day (QID), for 7 days
  2. 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)

PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution

Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution

60 eyes will be evaluated with the following therapeutic regimen:

  1. instill one drop in each eye of Moxifloxacin, every 8 hours per day, for 7 days.
  2. 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day for 7 days. (Can be applied 15 minutes after moxifloxacin)

Vigamox: Vigamox® (Moxifloxacin 0.5%), Alcon Laboratories, S.A. de C.V., ophthalmic solution

Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution

60 eyes will be evaluated with the following therapeutic regimen:

  1. instill one drop in each eye of Gatifloxacin, every 8 hours per day, for 7 days.
  2. 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day for 7 days.one drop 4 times a day for 7 days in each eye.(Can be applied 15 minutes after gatifloxacin)

Zymar®: Zymar® (Gatifloxacin 0.3%), Allergan, S.A. de C.V., ophthalmic solution

Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution

Overall Number of Participants Analyzed 15 8 13 15 9
Overall Number of Units Analyzed
Type of Units Analyzed: Cultures
30 16 26 29 17
Measure Type: Number
Unit of Measure: cultures
basal cultures positives 30 16 26 29 17
final cultures negatives 17 14 16 28 15
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PRO-157 BID (2 Times Per Day), PRO-157 TID (3 Times Per Day), PRO-157 QID (4 Times Per Day), Moxifloxacin (Vigamox®), Gatifloxacin (Zymar®)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The aim of this study was to find the ideal dose of treatment for bacterial eradication and non-inferiority with the comparative groups.
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
2.Primary Outcome
Title Adverse Events
Hide Description Number of adverse events: dependent variable, discrete quantitative, the number of adverse events per group will be compared at the end of the study and it will be considered safe if there is not greater increase of 5% of serious adverse events.
Time Frame during the intervention period for 7 days, and 15 days after the final visit
Hide Outcome Measure Data
Hide Analysis Population Description
Treatment analysis
Arm/Group Title PRO-157 BID (2 Times Per Day) PRO-157 TID (3 Times Per Day) PRO-157 QID (4 Times Per Day) Moxifloxacin (Vigamox®) Gatifloxacin (Zymar®)
Hide Arm/Group Description:

60 eyes will be evaluated with the following therapeutic regimen:

  1. instill one drop in each eye of PRO-157 (pazufloxacin), every 12 hours per day (BID), for 7 days
  2. instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%)every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)

PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution

Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution

60 eyes will be evaluated with the following therapeutic regimen:

  1. instill one drop in each eye of PRO-157 (pazufloxacin), every 8 hours per day (TID), for 7 days
  2. 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)

PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution

Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution

60 eyes will be evaluated with the following therapeutic regimen:

  1. instill one drop in each eye of PRO-157 (pazufloxacin), every 6 hours per day (QID), for 7 days
  2. 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)

PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution

Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution

60 eyes will be evaluated with the following therapeutic regimen:

  1. instill one drop in each eye of Moxifloxacin, every 8 hours per day, for 7 days.
  2. 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day for 7 days. (Can be applied 15 minutes after moxifloxacin)

Vigamox: Vigamox® (Moxifloxacin 0.5%), Alcon Laboratories, S.A. de C.V., ophthalmic solution

Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution

60 eyes will be evaluated with the following therapeutic regimen:

  1. instill one drop in each eye of Gatifloxacin, every 8 hours per day, for 7 days.
  2. 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day for 7 days.one drop 4 times a day for 7 days in each eye.(Can be applied 15 minutes after gatifloxacin)

Zymar®: Zymar® (Gatifloxacin 0.3%), Allergan, S.A. de C.V., ophthalmic solution

Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution

Overall Number of Participants Analyzed 27 19 24 21 20
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
54 38 48 42 40
Measure Type: Number
Unit of Measure: events
7 5 7 4 7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PRO-157 BID (2 Times Per Day), PRO-157 TID (3 Times Per Day), PRO-157 QID (4 Times Per Day), Moxifloxacin (Vigamox®), Gatifloxacin (Zymar®)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments The aim of this study was to find the ideal dose of treatment for bacterial eradication and non-inferiority with the comparative groups.
Statistical Test of Hypothesis P-Value 0.372
Comments [Not Specified]
Method Chi-squared, Corrected
Comments [Not Specified]
3.Secondary Outcome
Title Cases Frequency of Ocular Secretion
Hide Description Secretion ocular: qualitative ordinal variable. The secretion was evaluated by subject of study as present / absent, taking into consideration that each study subject represents two probable cases, one for each eye. On this premise, the statistical analysis of the number of cases reported in the final visit was made by study group.
Time Frame Up to one week.
Hide Outcome Measure Data
Hide Analysis Population Description
treatment analysis.
Arm/Group Title PRO-157 BID (2 Times Per Day) PRO-157 TID (3 Times Per Day) PRO-157 QID (4 Times Per Day) Moxifloxacin (Vigamox®) Gatifloxacin (Zymar®)
Hide Arm/Group Description:

60 eyes will be evaluated with the following therapeutic regimen:

  1. instill one drop in each eye of PRO-157 (pazufloxacin), every 12 hours per day (BID), for 7 days
  2. instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%)every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)

PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution

Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution

60 eyes will be evaluated with the following therapeutic regimen:

  1. instill one drop in each eye of PRO-157 (pazufloxacin), every 8 hours per day (TID), for 7 days
  2. 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)

PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution

Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution

60 eyes will be evaluated with the following therapeutic regimen:

  1. instill one drop in each eye of PRO-157 (pazufloxacin), every 6 hours per day (QID), for 7 days
  2. 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)

PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution

Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution

60 eyes will be evaluated with the following therapeutic regimen:

  1. instill one drop in each eye of Moxifloxacin, every 8 hours per day, for 7 days.
  2. 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day for 7 days. (Can be applied 15 minutes after moxifloxacin)

Vigamox: Vigamox® (Moxifloxacin 0.5%), Alcon Laboratories, S.A. de C.V., ophthalmic solution

Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution

60 eyes will be evaluated with the following therapeutic regimen:

  1. instill one drop in each eye of Gatifloxacin, every 8 hours per day, for 7 days.
  2. 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day for 7 days.one drop 4 times a day for 7 days in each eye.(Can be applied 15 minutes after gatifloxacin)

Zymar®: Zymar® (Gatifloxacin 0.3%), Allergan, S.A. de C.V., ophthalmic solution

Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution

Overall Number of Participants Analyzed 27 19 24 21 20
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
54 38 48 42 40
Measure Type: Number
Unit of Measure: secretion cases reported
0 3 0 7 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PRO-157 BID (2 Times Per Day), PRO-157 TID (3 Times Per Day), PRO-157 QID (4 Times Per Day), Moxifloxacin (Vigamox®), Gatifloxacin (Zymar®)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments The aim of this study was to find the ideal dose of treatment for bacterial eradication and non-inferiority with the comparative groups.
Statistical Test of Hypothesis P-Value 0.341
Comments [Not Specified]
Method Chi-squared, Corrected
Comments [Not Specified]
4.Secondary Outcome
Title Number of Cases of Conjunctival Hyperemia
Hide Description Conjunctival hyperemia: qualitative ordinal variable. The conjunctival hyperemia was evaluated by subject of study as present / absent, taking into consideration that each study subject represents two probable cases, one for each eye. On this premise, the statistical analysis of the number of cases reported in the final visit was made by study group.
Time Frame up to one week
Hide Outcome Measure Data
Hide Analysis Population Description
Treatment analysis
Arm/Group Title PRO-157 BID (2 Times Per Day) PRO-157 TID (3 Times Per Day) PRO-157 QID (4 Times Per Day) Moxifloxacin (Vigamox®) Gatifloxacin (Zymar®)
Hide Arm/Group Description:

60 eyes will be evaluated with the following therapeutic regimen:

  1. instill one drop in each eye of PRO-157 (pazufloxacin), every 12 hours per day (BID), for 7 days
  2. instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%)every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)

PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution

Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution

60 eyes will be evaluated with the following therapeutic regimen:

  1. instill one drop in each eye of PRO-157 (pazufloxacin), every 8 hours per day (TID), for 7 days
  2. 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)

PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution

Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution

60 eyes will be evaluated with the following therapeutic regimen:

  1. instill one drop in each eye of PRO-157 (pazufloxacin), every 6 hours per day (QID), for 7 days
  2. 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)

PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution

Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution

60 eyes will be evaluated with the following therapeutic regimen:

  1. instill one drop in each eye of Moxifloxacin, every 8 hours per day, for 7 days.
  2. 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day for 7 days. (Can be applied 15 minutes after moxifloxacin)

Vigamox: Vigamox® (Moxifloxacin 0.5%), Alcon Laboratories, S.A. de C.V., ophthalmic solution

Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution

60 eyes will be evaluated with the following therapeutic regimen:

  1. instill one drop in each eye of Gatifloxacin, every 8 hours per day, for 7 days.
  2. 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day for 7 days.one drop 4 times a day for 7 days in each eye.(Can be applied 15 minutes after gatifloxacin)

Zymar®: Zymar® (Gatifloxacin 0.3%), Allergan, S.A. de C.V., ophthalmic solution

Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution

Overall Number of Participants Analyzed 27 19 24 21 20
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
54 38 48 42 40
Measure Type: Number
Unit of Measure: hyperemia cases reported
17 1 5 7 8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PRO-157 BID (2 Times Per Day), PRO-157 TID (3 Times Per Day), PRO-157 QID (4 Times Per Day), Moxifloxacin (Vigamox®), Gatifloxacin (Zymar®)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments The aim of this study was to find the ideal dose of treatment for bacterial eradication and non-inferiority with the comparative groups.
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Chi-squared, Corrected
Comments [Not Specified]
5.Secondary Outcome
Title Chemosis Frequency
Hide Description Chemosis: qualitative ordinal variable, measurement scale absent or present. The chemosis was evaluated by subject of study as present / absent, taking into consideration that each study subject represents two probable cases, one for each eye. On this premise, the statistical analysis of the number of cases reported in the final visit was made by study group.
Time Frame up to one week
Hide Outcome Measure Data
Hide Analysis Population Description
Treatment analysis
Arm/Group Title PRO-157 BID (2 Times Per Day) PRO-157 TID (3 Times Per Day) PRO-157 QID (4 Times Per Day) Moxifloxacin (Vigamox®) Gatifloxacin (Zymar®)
Hide Arm/Group Description:

60 eyes will be evaluated with the following therapeutic regimen:

  1. instill one drop in each eye of PRO-157 (pazufloxacin), every 12 hours per day (BID), for 7 days
  2. instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%)every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)

PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution

Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution

60 eyes will be evaluated with the following therapeutic regimen:

  1. instill one drop in each eye of PRO-157 (pazufloxacin), every 8 hours per day (TID), for 7 days
  2. 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)

PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution

Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution

60 eyes will be evaluated with the following therapeutic regimen:

  1. instill one drop in each eye of PRO-157 (pazufloxacin), every 6 hours per day (QID), for 7 days
  2. 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)

PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution

Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution

60 eyes will be evaluated with the following therapeutic regimen:

  1. instill one drop in each eye of Moxifloxacin, every 8 hours per day, for 7 days.
  2. 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day for 7 days. (Can be applied 15 minutes after moxifloxacin)

Vigamox: Vigamox® (Moxifloxacin 0.5%), Alcon Laboratories, S.A. de C.V., ophthalmic solution

Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution

60 eyes will be evaluated with the following therapeutic regimen:

  1. instill one drop in each eye of Gatifloxacin, every 8 hours per day, for 7 days.
  2. 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day for 7 days.one drop 4 times a day for 7 days in each eye.(Can be applied 15 minutes after gatifloxacin)

Zymar®: Zymar® (Gatifloxacin 0.3%), Allergan, S.A. de C.V., ophthalmic solution

Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution

Overall Number of Participants Analyzed 27 19 24 21 20
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
54 38 48 42 40
Measure Type: Number
Unit of Measure: chemosis cases reported
0 0 0 6 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PRO-157 BID (2 Times Per Day), PRO-157 TID (3 Times Per Day), PRO-157 QID (4 Times Per Day), Moxifloxacin (Vigamox®), Gatifloxacin (Zymar®)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments The aim of this study was to find the ideal dose of treatment for bacterial eradication and non-inferiority with the comparative groups.
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method Chi-squared, Corrected
Comments [Not Specified]
6.Secondary Outcome
Title Eyelid Edema Frequency
Hide Description

Eyelid edema: qualitative ordinal variable, measurement scale absent or present.Between baseline (day 0) versus final visit (day 7).

The eyelid edema was evaluated by subject of study as present / absent, taking into consideration that each study subject represents two probable cases, one for each eye. On this premise, the statistical analysis of the number of cases reported in the final visit was made by study group.

Time Frame Up to one week
Hide Outcome Measure Data
Hide Analysis Population Description
Treatment analysis
Arm/Group Title PRO-157 BID (2 Times Per Day) PRO-157 TID (3 Times Per Day) PRO-157 QID (4 Times Per Day) Moxifloxacin (Vigamox®) Gatifloxacin (Zymar®)
Hide Arm/Group Description:

60 eyes will be evaluated with the following therapeutic regimen:

  1. instill one drop in each eye of PRO-157 (pazufloxacin), every 12 hours per day (BID), for 7 days
  2. instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%)every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)

PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution

Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution

60 eyes will be evaluated with the following therapeutic regimen:

  1. instill one drop in each eye of PRO-157 (pazufloxacin), every 8 hours per day (TID), for 7 days
  2. 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)

PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution

Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution

60 eyes will be evaluated with the following therapeutic regimen:

  1. instill one drop in each eye of PRO-157 (pazufloxacin), every 6 hours per day (QID), for 7 days
  2. 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)

PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution

Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution

60 eyes will be evaluated with the following therapeutic regimen:

  1. instill one drop in each eye of Moxifloxacin, every 8 hours per day, for 7 days.
  2. 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day for 7 days. (Can be applied 15 minutes after moxifloxacin)

Vigamox: Vigamox® (Moxifloxacin 0.5%), Alcon Laboratories, S.A. de C.V., ophthalmic solution

Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution

60 eyes will be evaluated with the following therapeutic regimen:

  1. instill one drop in each eye of Gatifloxacin, every 8 hours per day, for 7 days.
  2. 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day for 7 days.one drop 4 times a day for 7 days in each eye.(Can be applied 15 minutes after gatifloxacin)

Zymar®: Zymar® (Gatifloxacin 0.3%), Allergan, S.A. de C.V., ophthalmic solution

Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution

Overall Number of Participants Analyzed 27 19 24 21 20
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
54 38 48 42 40
Measure Type: Number
Unit of Measure: eyelid edema cases reported
6 0 4 4 6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PRO-157 BID (2 Times Per Day), PRO-157 TID (3 Times Per Day), PRO-157 QID (4 Times Per Day), Moxifloxacin (Vigamox®), Gatifloxacin (Zymar®)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments The aim of this study was to find the ideal dose of treatment for bacterial eradication and non-inferiority with the comparative groups.
Statistical Test of Hypothesis P-Value 0.216
Comments [Not Specified]
Method Chi-squared, Corrected
Comments [Not Specified]
7.Secondary Outcome
Title Frequency of Corneal Epithelial Defects
Hide Description

Corneal epithelial defects: qualitative ordinal variable, measurement scale present or absent.

The corneal epithelial defects was evaluated by subject of study as present / absent, taking into consideration that each study subject represents two probable cases, one for each eye. On this premise, the statistical analysis of the number of cases reported in the final visit was made by study group.

Time Frame Up to one week
Hide Outcome Measure Data
Hide Analysis Population Description
Treatment analysis
Arm/Group Title PRO-157 BID (2 Times Per Day) PRO-157 TID (3 Times Per Day) PRO-157 QID (4 Times Per Day) Moxifloxacin (Vigamox®) Gatifloxacin (Zymar®)
Hide Arm/Group Description:

60 eyes will be evaluated with the following therapeutic regimen:

  1. instill one drop in each eye of PRO-157 (pazufloxacin), every 12 hours per day (BID), for 7 days
  2. instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%)every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)

PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution

Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution

60 eyes will be evaluated with the following therapeutic regimen:

  1. instill one drop in each eye of PRO-157 (pazufloxacin), every 8 hours per day (TID), for 7 days
  2. 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)

PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution

Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution

60 eyes will be evaluated with the following therapeutic regimen:

  1. instill one drop in each eye of PRO-157 (pazufloxacin), every 6 hours per day (QID), for 7 days
  2. 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)

PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution

Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution

60 eyes will be evaluated with the following therapeutic regimen:

  1. instill one drop in each eye of Moxifloxacin, every 8 hours per day, for 7 days.
  2. 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day for 7 days. (Can be applied 15 minutes after moxifloxacin)

Vigamox: Vigamox® (Moxifloxacin 0.5%), Alcon Laboratories, S.A. de C.V., ophthalmic solution

Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution

60 eyes will be evaluated with the following therapeutic regimen:

  1. instill one drop in each eye of Gatifloxacin, every 8 hours per day, for 7 days.
  2. 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day for 7 days.one drop 4 times a day for 7 days in each eye.(Can be applied 15 minutes after gatifloxacin)

Zymar®: Zymar® (Gatifloxacin 0.3%), Allergan, S.A. de C.V., ophthalmic solution

Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution

Overall Number of Participants Analyzed 27 19 24 21 20
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
54 38 48 42 40
Measure Type: Number
Unit of Measure: Corneal defects cases reported
9 4 6 5 5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PRO-157 BID (2 Times Per Day), PRO-157 TID (3 Times Per Day), PRO-157 QID (4 Times Per Day), Moxifloxacin (Vigamox®), Gatifloxacin (Zymar®)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments The aim of this study was to find the ideal dose of treatment for bacterial eradication and non-inferiority with the comparative groups.
Statistical Test of Hypothesis P-Value 0.829
Comments [Not Specified]
Method Chi-squared, Corrected
Comments [Not Specified]
Time Frame Adverse events were monitored during the intervention period for 8 days, and a follow-up call was made 15 days after the final visit.
Adverse Event Reporting Description Adverse events were recorded according to the patient's scheduled or unscheduled visits, and were given a diary in which they could make annotations of their symptoms, the investigator reviewed these symptoms and reported on them The format of adverse events.
 
Arm/Group Title PRO-157 BID (2 Times Per Day) PRO-157 TID (3 Times Per Day) PRO-157 QID (4 Times Per Day) Moxifloxacin (Vigamox®) Gatifloxacin (Zymar®)
Hide Arm/Group Description

60 eyes will be evaluated with the following therapeutic regimen:

  1. instill one drop in each eye of PRO-157 (pazufloxacin), every 12 hours per day (BID), for 7 days
  2. instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%)every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)

PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution

Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution

60 eyes will be evaluated with the following therapeutic regimen:

  1. instill one drop in each eye of PRO-157 (pazufloxacin), every 8 hours per day (TID), for 7 days
  2. 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)

PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution

Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution

60 eyes will be evaluated with the following therapeutic regimen:

  1. instill one drop in each eye of PRO-157 (pazufloxacin), every 6 hours per day (QID), for 7 days
  2. 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)

PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution

Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution

60 eyes will be evaluated with the following therapeutic regimen:

  1. instill one drop in each eye of Moxifloxacin, every 8 hours per day, for 7 days.
  2. 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day for 7 days. (Can be applied 15 minutes after moxifloxacin)

Vigamox: Vigamox® (Moxifloxacin 0.5%), Alcon Laboratories, S.A. de C.V., ophthalmic solution

Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution

60 eyes will be evaluated with the following therapeutic regimen:

  1. instill one drop in each eye of Gatifloxacin, every 8 hours per day, for 7 days.
  2. 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day for 7 days.one drop 4 times a day for 7 days in each eye.(Can be applied 15 minutes after gatifloxacin)

Zymar®: Zymar® (Gatifloxacin 0.3%), Allergan, S.A. de C.V., ophthalmic solution

Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution

All-Cause Mortality
PRO-157 BID (2 Times Per Day) PRO-157 TID (3 Times Per Day) PRO-157 QID (4 Times Per Day) Moxifloxacin (Vigamox®) Gatifloxacin (Zymar®)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
PRO-157 BID (2 Times Per Day) PRO-157 TID (3 Times Per Day) PRO-157 QID (4 Times Per Day) Moxifloxacin (Vigamox®) Gatifloxacin (Zymar®)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/30 (0.00%)      0/30 (0.00%)      0/30 (0.00%)      1/30 (3.33%)      1/30 (3.33%)    
Eye disorders           
ischemic optic neuropathy *  0/30 (0.00%)  0 0/30 (0.00%)  0 0/30 (0.00%)  0 0/30 (0.00%)  0 1/30 (3.33%)  1
Renal and urinary disorders           
urinary tract infection (ITU) *  0/30 (0.00%)  0 0/30 (0.00%)  0 0/30 (0.00%)  0 1/30 (3.33%)  1 0/30 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
PRO-157 BID (2 Times Per Day) PRO-157 TID (3 Times Per Day) PRO-157 QID (4 Times Per Day) Moxifloxacin (Vigamox®) Gatifloxacin (Zymar®)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/30 (23.33%)      5/30 (16.67%)      7/30 (23.33%)      3/30 (10.00%)      6/30 (20.00%)    
Ear and labyrinth disorders           
Tinnitus *  0/30 (0.00%)  0 1/30 (3.33%)  1 0/30 (0.00%)  0 0/30 (0.00%)  0 1/30 (3.33%)  1
Eye disorders           
Eyelid ecchymosis *  0/30 (0.00%)  0 1/30 (3.33%)  1 0/30 (0.00%)  0 0/30 (0.00%)  0 0/30 (0.00%)  0
hordeolum *  0/30 (0.00%)  0 0/30 (0.00%)  0 1/30 (3.33%)  1 0/30 (0.00%)  0 0/30 (0.00%)  0
eye pain   1/30 (3.33%)  1 0/30 (0.00%)  0 0/30 (0.00%)  0 0/30 (0.00%)  0 0/30 (0.00%)  0
Numular keratitis *  2/30 (6.67%)  2 0/30 (0.00%)  0 0/30 (0.00%)  0 0/30 (0.00%)  0 2/30 (6.67%)  2
Irritant conjunctivitis *  0/30 (0.00%)  0 0/30 (0.00%)  0 0/30 (0.00%)  0 1/30 (3.33%)  1 0/30 (0.00%)  0
Preseptal cellulitis *  0/30 (0.00%)  0 0/30 (0.00%)  0 0/30 (0.00%)  0 0/30 (0.00%)  0 1/30 (3.33%)  1
Gastrointestinal disorders           
stomach flu *  0/30 (0.00%)  0 1/30 (3.33%)  1 0/30 (0.00%)  0 0/30 (0.00%)  0 0/30 (0.00%)  0
Dysgeusia *  1/30 (3.33%)  1 0/30 (0.00%)  0 1/30 (3.33%)  1 1/30 (3.33%)  1 0/30 (0.00%)  0
gastritis *  1/30 (3.33%)  1 0/30 (0.00%)  0 0/30 (0.00%)  0 0/30 (0.00%)  0 0/30 (0.00%)  0
constipation *  0/30 (0.00%)  0 0/30 (0.00%)  0 1/30 (3.33%)  1 0/30 (0.00%)  0 0/30 (0.00%)  0
stomachache *  0/30 (0.00%)  0 0/30 (0.00%)  0 0/30 (0.00%)  0 1/30 (3.33%)  1 0/30 (0.00%)  0
General disorders           
Lack of effectiveness   0/30 (0.00%)  0 0/30 (0.00%)  0 3/30 (10.00%)  3 0/30 (0.00%)  0 1/30 (3.33%)  1
Infections and infestations           
Pharyngotonsillitis *  0/30 (0.00%)  0 1/30 (3.33%)  1 0/30 (0.00%)  0 0/30 (0.00%)  0 0/30 (0.00%)  0
Nervous system disorders           
dizziness   1/30 (3.33%)  1 0/30 (0.00%)  0 0/30 (0.00%)  0 0/30 (0.00%)  0 0/30 (0.00%)  0
Headache *  1/30 (3.33%)  1 1/30 (3.33%)  1 1/30 (3.33%)  1 0/30 (0.00%)  0 0/30 (0.00%)  0
Vascular disorders           
Systemic hypertension   0/30 (0.00%)  0 0/30 (0.00%)  0 0/30 (0.00%)  0 0/30 (0.00%)  0 1/30 (3.33%)  1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
In the present study the efficacy of pazufloxacin at different doses has not been demonstrated. In addition, the minimum inhibitory dose for ophthalmic administration is not established. Cultures could also not be determined in all study subjects.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
PI (s) can not make use of the partial or total information of this investigation, due to the clauses contained in the agreement of confidentiality of the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical pharmacologist
Organization: Laboratorios Sophia
Phone: +52 (33) 3001 4200 ext 1259
EMail: ricardo.llamas@sophia.com.mx
Layout table for additonal information
Responsible Party: Laboratorios Sophia S.A de C.V.
ClinicalTrials.gov Identifier: NCT02980523     History of Changes
Other Study ID Numbers: SOPH157-0114/II
First Submitted: November 17, 2016
First Posted: December 2, 2016
Results First Submitted: June 21, 2017
Results First Posted: February 15, 2019
Last Update Posted: May 22, 2019