Inflammation Associated With Cataract Surgery Clinical Trial
Official title:
A Multicenter, Randomized, Double-masked, Dose-ranging, Phase 2 Study to Evaluate the Efficacy and Safety of IBI-10090 for the Treatment of Inflammation Associated With Ocular Surgery
| Verified date | September 2014 |
| Source | ICON Bioscience Inc |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
This study will test the efficacy and safety of IBI-10090 in the treatment of ocular inflammation after ocular surgery.
| Status | Completed |
| Enrollment | 172 |
| Est. completion date | March 2013 |
| Est. primary completion date | March 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 40 Years and older |
| Eligibility |
Inclusion Criteria: - Patients scheduled for unilateral cataract surgery Exclusion Criteria: - Ocular, topical, or oral corticosteroids within 7 days of Day 0 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Inland Eye Specialists | Hemet | California |
| United States | California Eye Professionals | Temecula | California |
| Lead Sponsor | Collaborator |
|---|---|
| ICON Bioscience Inc |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Anterior Chamber Cell Count at Day 8 Post-Treatment | This study will measure as its primary endpoint the anterior chamber cell count at Day 8 post-treatment. The proportion of patients with anterior chamber cell count = 0 at Day 8 for each dosage group will be compared. | 8 days post-treatment | Yes |