Trials / Completed
CompletedNCT02547623
Study to Evaluate the Safety for the Treatment of Inflammation Associated With Cataract Surgery
A Phase 3, Prospective, Randomized, Parallel-design, Multicenter Study to Evaluate the Safety of Icon Bioscience-10090 for the Treatment of Inflammation Associated With Cataract Surgery
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 194 (actual)
- Sponsor
- ICON Bioscience Inc · Industry
- Sex
- All
- Age
- 40 Years
- Healthy volunteers
- Not accepted
Summary
The study is a prospective, randomized, parallel-design, multicenter trial in patients ≥40 years of age undergoing cataract surgery. Patients who meet all inclusion and no exclusion criteria will be randomized to 1 of 2 treatment groups * A single 5 mcl anterior chamber injection of IBI 10090, 103.4 mcg/mcl dexamethasone, equivalent dexamethasone dose: 517 mcg at the conclusion of cataract surgery or; * Prednisolone acetate ophthalmic suspension 1% eye drops administered 1 drop 4 times daily (QID) for 3 weeks Safety will be assessed by adverse events (AEs), slit lamp biomicroscopy, fundus examination, intraocular pressure (IOP), visual acuity, and specular microscopy endothelial cell count.
Detailed description
The study is a prospective, randomized, parallel-design, multicenter trial in patients ≥40 years of age undergoing cataract surgery. Patients who meet all inclusion and no exclusion criteria will be randomized to 1 of 2 treatment groups * A single 5 mcl anterior chamber injection of IBI 10090, 103.4 mcg/mcl dexamethasone, equivalent dexamethasone dose: 517 mcg at the conclusion of cataract surgery or; * Prednisolone acetate ophthalmic suspension 1% eye drops administered 1 drop 4 times daily (QID) for 3 weeks
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dexamethasone | depot intracameral |
| DRUG | Prednisolone | Prednisolone eye drops 1% |
Timeline
- Start date
- 2015-11-06
- Primary completion
- 2016-08-16
- Completion
- 2016-08-16
- First posted
- 2015-09-11
- Last updated
- 2018-08-21
- Results posted
- 2018-06-19
Locations
11 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02547623. Inclusion in this directory is not an endorsement.