Efficacy and Safety Study of IBI-10090 in Cataract Surgery Patients
- Registration Number
- NCT01214174
- Lead Sponsor
- ICON Bioscience Inc
- Brief Summary
This study will test the efficacy and safety of IBI-10090 in the treatment of ocular inflammation after cataract surgery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 42
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dose 1 IBI-10090 513ug Dose 2 IBI-10090 776ug Dose 3 IBI-10090 1046ug
- Primary Outcome Measures
Name Time Method Proportion of Patients With Anterior Chamber Cell Clearing at Day 8 Post-Treatment 8 days post-treatment 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Drs. Fine, Hoffman, and Packer
🇺🇸Eugene, Oregon, United States