Study to Evaluate the Safety for the Treatment of Inflammation Associated With Cataract Surgery
| Status: | Completed |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 40 - Any |
| Updated: | 8/23/2018 |
| Start Date: | November 6, 2015 |
| End Date: | August 16, 2016 |
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
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.
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.
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
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
Inclusion Criteria:
- undergoing cataract surgery
Exclusion Criteria:
- glaucoma patient, pregnancy, allergy to dexamethasone
We found this trial at
11
sites
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