Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Gatifloxacin 0.5% eye · 2 trials · 1 indication
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).
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).
| Arm | Type | Description |
|---|---|---|
| Gatifloxacin 0.5% Eye Drops | EXPERIMENTAL | Gatifloxacin 0.5% Eye Drops |
| Placebo Eye Drops | PLACEBO_COMPARATOR | Placebo Eye Drops |
| Name | Type | Description |
|---|---|---|
| Gatifloxacin 0.5% eye drops | DRUG | Day 1 = 1 drop of study medication every 2hrs up to 8 times total; day 2-5 = 1 drop twice daily |
| placebo eye drops | DRUG | Day 1 = 1 drop of study medication every 2hrs up to 8 times total; day 2-5 = 1 drop twice daily |
Inclusion Criteria: * Clinically diagnosed with bacterial conjunctivitis Exclusion Criteria: * Signs and/or symptoms of conjunctivitis for more than 96 hours * Signs and/or symptoms suggestive of fungal, viral, or allergic conjunctivitis * Clinical diagnosis of chlamydia in either eye
Gatifloxacin 0.5% eye is an investigational small molecule being developed for the treatment of bacterial conjunctivitis, an infection of the eye's outer membrane. It is administered as an eye drop. The drug is currently in Phase 3 clinical development and has not been approved by the FDA.
Gatifloxacin 0.5% eye is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The company is conducting clinical trials to evaluate the safety and efficacy of this drug in patients with bacterial conjunctivitis.
Gatifloxacin 0.5% eye is in Phase 3 clinical development for bacterial conjunctivitis. Two Phase 3 trials have been completed, with a total of 1,437 participants enrolled. The drug is investigational and has not received FDA approval.
Gatifloxacin 0.5% eye has been studied in two completed Phase 3 trials: NCT00509873, which enrolled 578 patients in the United States, and NCT00518089, which enrolled 859 patients in the United States and India. Both trials were randomized, double-blind, and placebo-controlled, and included patients as young as 1 year old.
Gatifloxacin 0.5% eye is a specific ophthalmic formulation of gatifloxacin, a fluoroquinolone antibiotic. The 0.5% concentration is designed for topical use in the eye to treat bacterial conjunctivitis. This formulation is distinct from systemic gatifloxacin products used for other infections.