Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 22 of 26 for:    "Bacterial Conjunctivitis" | "Anti-Bacterial Agents"

A Study of the Safety and Efficacy of Gatifloxacin in Patients With 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: NCT00509873
Recruitment Status : Completed
First Posted : August 1, 2007
Results First Posted : November 30, 2011
Last Update Posted : November 30, 2011
Sponsor:
Information provided by (Responsible Party):
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 0.5% eye drops
Drug: placebo eye drops
Enrollment 578
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Gatifloxacin 0.5% Eye Drops Placebo Eye Drops
Hide Arm/Group Description Gatifloxacin 0.5% eye drops Placebo eye drops
Period Title: Overall Study
Started 287 291
Completed 276 276
Not Completed 11 15
Arm/Group Title Gatifloxacin 0.5% Eye Drops Placebo Eye Drops Total
Hide Arm/Group Description Gatifloxacin 0.5% eye drops Placebo eye drops Total of all reporting groups
Overall Number of Baseline Participants 287 291 578
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 287 participants 291 participants 578 participants
1-18 years 123 123 246
19-65 years 126 141 267
>65 years 38 27 65
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 287 participants 291 participants 578 participants
Female
161
  56.1%
172
  59.1%
333
  57.6%
Male
126
  43.9%
119
  40.9%
245
  42.4%
1.Primary Outcome
Title Percentage of Patients With Clearing (Clinical Success) of Conjunctival Hyperemia and Conjunctival Discharge at Day 6
Hide Description Percentage of patients that achieved clinical success, defined as achievement of a score of zero for both conjunctival hyperemia and conjunctival discharge in the study eye at Day 6. Conjunctival hyperemia and conjunctival discharge were each assessed on a 4-point severity grade scale (0=none, +1=mild, +2=moderate, +3=severe).
Time Frame Day 6
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. (Note: The Day 6 analysis included all Day 6 visit data, regardless of whether it was collected on Day 6 or on a later day).
Arm/Group Title Gatifloxacin 0.5% Eye Drops Placebo Eye Drops
Hide Arm/Group Description:
Gatifloxacin 0.5% eye drops
Placebo eye drops
Overall Number of Participants Analyzed 167 158
Measure Type: Number
Unit of Measure: Percentage of Patients
74.9 65.2
2.Secondary Outcome
Title Percentage of Patients With Microbiological Cure at Day 6
Hide Description Percentage of patients with microbiological cure, defined such that all bacteria present in the study eye at Day 1 (Baseline) are eradicated (or absent) at Day 6 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 6
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. (Note: The Day 6 analysis included all Day 6 visit data, regardless of whether it was collected on Day 6 or on a later day).
Arm/Group Title Gatifloxacin 0.5% Eye Drops Placebo Eye Drops
Hide Arm/Group Description:
Gatifloxacin 0.5% eye drops
Placebo eye drops
Overall Number of Participants Analyzed 167 158
Measure Type: Number
Unit of Measure: Percentage of Patients
89.2 61.4
3.Secondary Outcome
Title Percentage of Patients With Clinical Improvement of Ocular Signs at Day 6
Hide Description Percentage of patients with clinical improvement of ocular signs at Day 6 based on a 4-point scale (0 = none, 1 = mild, 2 = moderate, and 3 = severe), defined as a decrease (improvement) from Day 1 (Baseline) in the total score of conjunctival hyperemia and mucopurulent discharge (pus),with no increase (worsening) from Day 1 (Baseline) in either individual variable in the study eye.
Time Frame Day 6
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. (Note: The Day 6 analysis included all Day 6 visit data, regardless of whether it was collected on Day 6 or on a later day).
Arm/Group Title Gatifloxacin 0.5% Eye Drops Placebo Eye Drops
Hide Arm/Group Description:
Gatifloxacin 0.5% eye drops
Placebo eye drops
Overall Number of Participants Analyzed 167 158
Measure Type: Number
Unit of Measure: Percentage of Patients
97.0 96.2
4.Secondary Outcome
Title Percentage of Patients With Clinical Improvement of Ocular Symptoms at Day 6
Hide Description Percentage of patients with clinical improvement of ocular symptoms at Day 6, defined as a decrease (improvement) from Day 1 (Baseline) in the total score of itching and tearing (each on 4-point scale: 0 = none, 1 = mild, 2 = moderate, and 3 = severe), with no increase (worsening) from Day 1 (Baseline) in any individual score in the study eye diagnosed with bacterial conjunctivitis
Time Frame Day 6
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. (Note: The Day 6 analysis included all Day 6 visit data, regardless of whether it was collected on Day 6 or on a later day).
Arm/Group Title Gatifloxacin 0.5% Eye Drops Placebo Eye Drops
Hide Arm/Group Description:
Gatifloxacin 0.5% eye drops
Placebo eye drops
Overall Number of Participants Analyzed 167 158
Measure Type: Number
Unit of Measure: Percentage of Patients
85.5 82.2
5.Post-Hoc Outcome
Title Percentage of Patients With Clearing (Clinical Success) of Conjunctival Hyperemia and Conjunctival Discharge Up to Day 6
Hide Description Percentage of patients that achieved clinical success, defined as achievement of a score of zero for both conjunctival hyperemia and conjunctival discharge in the study eye up to Day 6. Conjunctival hyperemia and conjunctival discharge were each assessed on a 4-point severity grade scale (0=none, +1=mild, +2=moderate, +3=severe). (Note: The "Up to Day 6" analysis included all data up to the Day 6 time point but excluded any Day 6 visit data that was collected after the Day 6 time point).
Time Frame 6 Days
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. (Note: The "Up to Day 6" analysis included all data up to the Day 6 time point but excluded any Day 6 visit data that was collected after the Day 6 time point).
Arm/Group Title Gatifloxacin 0.5% Eye Drops Placebo Eye Drops
Hide Arm/Group Description:
Gatifloxacin 0.5% eye drops
Placebo eye drops
Overall Number of Participants Analyzed 167 158
Measure Type: Number
Unit of Measure: Percentage of Patients
64.1 50.0
Time Frame [Not Specified]
Adverse Event Reporting Description Safety Population used for serious adverse event and adverse event analysis - defined as all patients who were randomized AND treated based on actual treatment received.
 
Arm/Group Title Gatifloxacin 0.5% Eye Drops Placebo Eye Drops
Hide Arm/Group Description Gatifloxacin 0.5% eye drops Placebo eye drops
All-Cause Mortality
Gatifloxacin 0.5% Eye Drops Placebo Eye Drops
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Gatifloxacin 0.5% Eye Drops Placebo Eye Drops
Affected / at Risk (%) Affected / at Risk (%)
Total   0/288 (0.00%)   1/289 (0.35%) 
Cardiac disorders     
Cardiac failure congestive  1  0/288 (0.00%)  1/289 (0.35%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Gatifloxacin 0.5% Eye Drops Placebo Eye Drops
Affected / at Risk (%) Affected / at Risk (%)
Total   14/288 (4.86%)   13/289 (4.50%) 
Infections and infestations     
Conjunctivitis bacterial  1  14/288 (4.86%)  13/289 (4.50%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
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: Allergan
ClinicalTrials.gov Identifier: NCT00509873     History of Changes
Other Study ID Numbers: 198782-004
First Submitted: July 30, 2007
First Posted: August 1, 2007
Results First Submitted: June 15, 2010
Results First Posted: November 30, 2011
Last Update Posted: November 30, 2011