A Phase 3 interventional study of Gatifloxacin 0.5% eye drops and placebo eye drops in Bacterial Conjunctivitis, sponsored by Allergan. Completed at 1 site in United States. Open to participants aged 1 Year and older. Per ClinicalTrials.gov, last updated 2011-11-30.
Sponsored by Allergan (part of AbbVie) · Phase 3, Interventional, and Treatment
The study will determine the safety and efficacy of gatifloxacin eye drops in patients with bacterial conjunctivitis
40 studies on the registry are indexed under Conjunctivitis, Bacterial; 2 are open to participants now.
This study's enrollment of 578 is above the median of 261 across 36 interventional studies indexed under Conjunctivitis, Bacterial.
Browse Conjunctivitis, Bacterial studies →Allergan is the lead sponsor of 505 studies on the registry; none are open to participants now.
Of its 93 completed or terminated interventional studies of FDA-regulated products, 91 (98%) have results posted.
First submitted before Allergan became part of AbbVie.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Gatifloxacin 0.5% Eye Drops
Drug: Gatifloxacin 0.5% eye drops
Placebo Eye Drops
Drug: placebo eye drops
Day 1 = 1 drop of study medication every 2hrs up to 8 times total; day 2-5 = 1 drop twice daily
Day 1 = 1 drop of study medication every 2hrs up to 8 times total; day 2-5 = 1 drop twice daily
Percentage of Patients With Clearing (Clinical Success) of Conjunctival Hyperemia and Conjunctival Discharge at Day 6
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
Percentage of Patients With Microbiological Cure at Day 6
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
Percentage of Patients With Clinical Improvement of Ocular Signs at Day 6
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
Percentage of Patients With Clinical Improvement of Ocular Symptoms at Day 6
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
| Milestone | Gatifloxacin 0.5% Eye Drops | Placebo Eye Drops |
|---|---|---|
| Started | 287 | 291 |
| Completed | 276 | 276 |
| Not completed | 11 | 15 |
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).
| Percentage of Patients | Gatifloxacin 0.5% Eye Drops | Placebo Eye Drops |
|---|---|---|
| Percentage of Patients With Clearing (Clinical Success) of Conjunctival Hyperemia and Conjunctival Discharge at Day 6 | 74.9 | 65.2 |
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)
| Percentage of Patients | Gatifloxacin 0.5% Eye Drops | Placebo Eye Drops |
|---|---|---|
| Percentage of Patients With Microbiological Cure at Day 6 | 89.2 | 61.4 |
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.
| Percentage of Patients | Gatifloxacin 0.5% Eye Drops | Placebo Eye Drops |
|---|---|---|
| Percentage of Patients With Clinical Improvement of Ocular Signs at Day 6 | 97.0 | 96.2 |
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
| Percentage of Patients | Gatifloxacin 0.5% Eye Drops | Placebo Eye Drops |
|---|---|---|
| Percentage of Patients With Clinical Improvement of Ocular Symptoms at Day 6 | 85.5 | 82.2 |
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).
| Percentage of Patients | Gatifloxacin 0.5% Eye Drops | Placebo Eye Drops |
|---|---|---|
| Percentage of Patients With Clearing (Clinical Success) of Conjunctival Hyperemia and Conjunctival Discharge Up to Day 6 | 64.1 | 50.0 |
Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Gatifloxacin 0.5% Eye Drops | — | 0/288 (0%) | 14/288 (4.9%) |
| Placebo Eye Drops | — | 1/289 (0.3%) | 13/289 (4.5%) |
| Event | Gatifloxacin 0.5% Eye Drops | Placebo Eye Drops |
|---|---|---|
| Cardiac failure congestiveCardiac disorders | 0/288 | 1/289 |
| Event | Gatifloxacin 0.5% Eye Drops | Placebo Eye Drops |
|---|---|---|
| Conjunctivitis bacterialInfections and infestations | 14/288 | 13/289 |
| Age, Customized(participants) | Gatifloxacin 0.5% Eye Drops | Placebo Eye Drops | Total |
|---|---|---|---|
| 1-18 years | 123 | 123 | 246 |
| 19-65 years | 126 | 141 | 267 |
| >65 years | 38 | 27 | 65 |
| Sex: Female, Male(Participants) | Gatifloxacin 0.5% Eye Drops | Placebo Eye Drops | Total |
|---|---|---|---|
| Female | 161 | 172 | 333 |
| Male | 126 | 119 | 245 |
The record gives a start of Aug 2007, a primary completion of Jun 2008 and a completion of Jun 2008. It does not say whether these dates are actual or estimated.
Results were first posted in Nov 2011, 3 years 5 months after primary completion. A results delay was requested in Jul 2009.
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This study is completed, as verified in Oct 2011. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Gatifloxacin