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Fluoroquinolone Antibiotic
Gatifloxacin 0.5% Eye Drops for Pink Eye
Phase 3
Waitlist Available
Research Sponsored by Allergan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* Clinically diagnosed with bacterial conjunctivitis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 6
Awards & highlights
All Individual Drugs Already Approved
Pivotal Trial
Summary
The study will determine the safety and efficacy of gatifloxacin eye drops in patients with bacterial conjunctivitis
Eligible Conditions
- Pink Eye
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 6
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 6
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of Patients With Clearing (Clinical Success) of Conjunctival Hyperemia and Conjunctival Discharge at Day 6
Secondary study objectives
Percentage of Patients With Clinical Improvement of Ocular Signs at Day 6
Percentage of Patients With Clinical Improvement of Ocular Symptoms at Day 6
Percentage of Patients With Microbiological Cure at Day 6
Side effects data
From 2008 Phase 3 trial • 578 Patients • NCT005098735%
Conjunctivitis bacterial
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo Eye Drops
Gatifloxacin 0.5% Eye Drops
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Gatifloxacin 0.5% Eye DropsExperimental Treatment1 Intervention
Gatifloxacin 0.5% Eye Drops
Group II: Placebo Eye DropsPlacebo Group1 Intervention
Placebo Eye Drops
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gatifloxacin
FDA approved
Find a Location
Who is running the clinical trial?
AllerganLead Sponsor
781 Previous Clinical Trials
276,107 Total Patients Enrolled
Medical DirectorStudy DirectorAllergan
2,895 Previous Clinical Trials
8,088,190 Total Patients Enrolled
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