Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Gatifloxacin 0.5% eye drops
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 being developed for the treatment of bacterial conjunctivitis, an infection of the eye's outer membrane. It is a small molecule anti-infective candidate studied in patients with this condition, including children as young as one year old.
Gatifloxacin 0.5% eye is being developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie is the sponsor behind the clinical program evaluating this ophthalmic anti-infective candidate for bacterial conjunctivitis.
Gatifloxacin 0.5% eye is in Phase 3 development. Two Phase 3 trials have been completed, and no trials are currently active. The program has enrolled 1,437 patients in total across its randomized, double-blind, placebo-controlled studies.
Gatifloxacin 0.5% eye has been studied in two completed Phase 3 trials: NCT00518089, which enrolled 859 patients in the United States and India, and NCT00509873, which enrolled 578 patients in the United States. Both trials evaluated safety and efficacy in bacterial conjunctivitis.
Yes, Gatifloxacin 0.5% eye and Gatifloxacin 0.5% eye drops refer to the same product. The 0.5% concentration describes the strength of the ophthalmic solution, and both names point to the same AbbVie anti-infective candidate under study for bacterial conjunctivitis.
Gatifloxacin 0.5% eye was evaluated in two randomized, double-blind, placebo-controlled Phase 3 trials in patients with bacterial conjunctivitis. Together the studies enrolled 1,437 participants, including patients one year of age and older, with sites in the United States and India.