Title
Efficacy and Safety Study of IBI-10090 in Cataract Surgery Patients
A Multicenter, Randomized, Double-masked, Dose-ranging, Phase 2 Study to Evaluate the Efficacy and Safety of IBI-10090 in Treating Inflammation in Cataract Surgery Patients
Phase
Phase 2Lead Sponsor
ICONStudy Type
InterventionalStatus
Terminated Results PostedIndication/Condition
Ocular InflammationIntervention/Treatment
dexamethasone ...Study Participants
42This study will test the efficacy and safety of IBI-10090 in the treatment of ocular inflammation after cataract surgery.
Inclusion Criteria: Male or female patients 40 years of age scheduled for unilateral cataract surgery (phacoemulsification or extracapsular extraction) with posterior chamber intraocular lens implantation. Exclusion Criteria: Patients who have used any ocular, topical, or oral corticosteroids within 7 days prior to Day 0. Patients who have used topical ocular NSAIDs in the study eye within 15 days prior to screening. Patients with any signs of intraocular inflammation in either eye at screening. Patients who have received any prior intravitreal injections in the study eye.
| Event Type | Organ System | Event Term | Dose 1 | Dose 2 | Dose 3 |
|---|
This study will measure as its primary endpoint the anterior chamber cell count at Day 8 post-treatment in the study eye. The proportion of patients with anterior chamber cell count = 0 at Day 8 in the study eye for each dosage group will be compared. Only one eye was treated per participant.
