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Trial record 23 of 26 for:    "Bacterial Conjunctivitis" | "Anti-Bacterial Agents"

A Study to Evaluate the Safety and Efficacy of Gatifloxacin for the Treatment of Bacterial Conjunctivitis

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: NCT00464438
Recruitment Status : Completed
First Posted : April 23, 2007
Results First Posted : September 21, 2011
Last Update Posted : September 21, 2011
Sponsor:
Information provided by:
Allergan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Bacterial Conjunctivitis
Interventions Drug: gatifloxacin
Drug: moxifloxacin 0.5% eye drops
Enrollment 171
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Gatifloxacin 0.3% Moxifloxacin 0.5%
Hide Arm/Group Description [Not Specified] [Not Specified]
Period Title: Overall Study
Started 85 86
Completed 83 80
Not Completed 2 6
Arm/Group Title Gatifloxacin 0.3% Moxifloxacin 0.5% Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 85 86 171
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 85 participants 86 participants 171 participants
15.2  (6.59) 15.2  (6.05) 15.2  (6.31)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 85 participants 86 participants 171 participants
Female
37
  43.5%
22
  25.6%
59
  34.5%
Male
48
  56.5%
64
  74.4%
112
  65.5%
1.Primary Outcome
Title Percentage of Patients With Clearing (Clinical Success) of Conjunctival Erythema and Conjunctival Discharge at Day 7
Hide Description Percentage of patients that achieved clinical success, defined as a score of 0 for both conjunctival erythema and conjunctival discharge at Day 7. Conjunctival erythema and conjunctival discharge were each assessed on a 4-point severity grade scale (0=none, +1=mild, +2=moderate, +3=severe).
Time Frame Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent to Treat; defined as all randomized patients who were "culture positive" at baseline meaning the culture of the eye grew bacteria.
Arm/Group Title Gatifloxacin 0.3% Moxifloxacin 0.5%
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 56 64
Measure Type: Number
Unit of Measure: Percentage of Patients
78.6 84.4
2.Secondary Outcome
Title Percentage of Patients With Microbiological Improvement
Hide Description Percentage of patients with microbiological improvement, defined such that all bacteria present above threshold at Day 1 (Baseline) are eradicated (absent) or reduced at Day 7 based on a Classification of Microbial Response (Eradication=pathogen is absent in follow-up culture; Reduction=pathogen is reduced from baseline below threshold count in follow-up culture; Persistence=pathogen reduced from baseline but is above or equal to threshold count in follow-up culture; and Proliferation=pathogen has increased in count from baseline in follow-up culture).
Time Frame Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent to Treat; defined as all randomized patients who were "culture positive" at baseline meaning the culture of the eye grew bacteria
Arm/Group Title Gatifloxacin 0.3% Moxifloxacin 0.5%
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 56 64
Measure Type: Number
Unit of Measure: Percentage of Patients
94.6 92.2
3.Secondary Outcome
Title Percentage of Patients With Improvement in Ocular Signs for Lid Erythema
Hide Description Percentage of patients with at least a 1-grade improvement in ocular signs for lid erythema at Day 7 from Day 1 (Baseline). Lid erythema was assessed on a 4-point severity grade scale (0=none, +1=mild, +2=moderate, +3=severe).
Time Frame Days 7
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent to Treat; defined as all randomized patients who were "culture positive" at baseline meaning the culture of the eye grew bacteria
Arm/Group Title Gatifloxacin 0.3% Moxifloxacin 0.5%
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 56 64
Measure Type: Number
Unit of Measure: Percentage of Patients
76.8 75.0
4.Secondary Outcome
Title Percentage of Patients With Improvement in Ocular Signs for Conjunctival Discharge at Day 7
Hide Description

Percentage of patients with at least a 1-grade improvement in ocular signs for conjunctival discharge at Day 7 from Day 1 (Baseline). Conjunctival discharge was assessed on a 4-point severity grade scale (0=none, +1=mild, +2=moderate,

+3=severe).

Time Frame Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent to Treat; defined as all randomized patients who were "culture positive" at baseline meaning the culture of the eye grew bacteria
Arm/Group Title Gatifloxacin 0.3% Moxifloxacin 0.5%
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 56 64
Measure Type: Number
Unit of Measure: Percentage of Patients
94.6 92.2
Time Frame [Not Specified]
Adverse Event Reporting Description Safety Population used for SAE/AE analysis - defined as all patients who were randomized AND treated. Intent-to-Treat Population used for Participant Flow - defined as all patients who were randomized.
 
Arm/Group Title Gatifloxacin 0.3% Moxifloxacin 0.5%
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Gatifloxacin 0.3% Moxifloxacin 0.5%
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Gatifloxacin 0.3% Moxifloxacin 0.5%
Affected / at Risk (%) Affected / at Risk (%)
Total   0/84 (0.00%)   1/86 (1.16%) 
Gastrointestinal disorders     
Pyrexia  1  0/84 (0.00%)  1/86 (1.16%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Gatifloxacin 0.3% Moxifloxacin 0.5%
Affected / at Risk (%) Affected / at Risk (%)
Total   11/84 (13.10%)   8/86 (9.30%) 
Eye disorders     
Conjunctivitis  1  4/84 (4.76%)  3/86 (3.49%) 
Infections and infestations     
Conjunctivitis bacterial  1  7/84 (8.33%)  5/86 (5.81%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.1
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.
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Therapeutic Area Head
Organization: Allergan, Inc.
Phone: (714) 246-4500
EMail: clinicaltrials@allergan.com
Layout table for additonal information
Responsible Party: Therapeutic Area Head, Allergan, Inc.
ClinicalTrials.gov Identifier: NCT00464438     History of Changes
Other Study ID Numbers: 198782-003
First Submitted: April 19, 2007
First Posted: April 23, 2007
Results First Submitted: June 15, 2010
Results First Posted: September 21, 2011
Last Update Posted: September 21, 2011