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Trial record 21 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: NCT00518089
Recruitment Status : Completed
First Posted : August 20, 2007
Results First Posted : November 30, 2011
Last Update Posted : April 23, 2019
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 859
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Gatifloxacin 0.5% Eye Drops Placebo Eye Drops
Hide Arm/Group Description [Not Specified] [Not Specified]
Period Title: Overall Study
Started 430 429
Completed 402 398
Not Completed 28 31
Arm/Group Title Gatifloxacin 0.5% Eye Drops Placebo Eye Drops Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 430 429 859
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 430 participants 429 participants 859 participants
1-18 years 66 74 140
19-65 years 316 313 629
>65 years 48 42 90
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 430 participants 429 participants 859 participants
Female
183
  42.6%
156
  36.4%
339
  39.5%
Male
247
  57.4%
273
  63.6%
520
  60.5%
1.Primary 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).
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:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 166 167
Measure Type: Number
Unit of Measure: Percentage of Patients
51.8 41.3
2.Secondary 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:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 166 167
Measure Type: Number
Unit of Measure: Percentage of Patients
59.6 46.7
3.Secondary Outcome
Title Percentage of Patients With Microbiological Cure Up to 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 up to 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 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:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 166 167
Measure Type: Number
Unit of Measure: Percentage of Patients
92.2 80.2
4.Secondary Outcome
Title Percentage of Patients With Clinical Improvement of Ocular Signs Up to Day 6
Hide Description Percentage of patients with clinical improvement of ocular signs up to 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 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:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 166 167
Measure Type: Number
Unit of Measure: Percentage of Patients
97.0 92.2
5.Secondary Outcome
Title Percentage of Patients With Clinical Improvement of Ocular Symptoms Up to Day 6
Hide Description Percentage of patients with clinical improvement of ocular symptoms, defined as a decrease (improvement) up to Day 6 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 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:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 166 167
Measure Type: Number
Unit of Measure: Percentage of Patients
92.8 88.6
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.
 
Arm/Group Title Gatifloxacin 0.5% Eye Drops Placebo Eye Drops
Hide Arm/Group Description [Not Specified] [Not Specified]
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   2/429 (0.47%)   0/427 (0.00%) 
Psychiatric disorders     
Anxiety  1  1/429 (0.23%)  0/427 (0.00%) 
Depression  1  1/429 (0.23%)  0/427 (0.00%) 
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   19/429 (4.43%)   26/427 (6.09%) 
Eye disorders     
Eye Irritation  1  14/429 (3.26%)  7/427 (1.64%) 
Infections and infestations     
Conjunctivitis bacterial  1  5/429 (1.17%)  19/427 (4.45%) 
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: NCT00518089     History of Changes
Other Study ID Numbers: 198782-005
First Submitted: August 16, 2007
First Posted: August 20, 2007
Results First Submitted: June 15, 2010
Results First Posted: November 30, 2011
Last Update Posted: April 23, 2019