Trials / Completed
CompletedNCT00782717
A Clinical Safety and Efficacy Comparison of NEVANAC 0.1% to Vehicle After Cataract Surgery in Diabetic Retinopathy Patients
A Clinical Safety and Efficacy Comparison of NEVANAC 0.1% to Vehicle Following Cataract Surgery in Diabetic Retinopathy Patients
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 263 (actual)
- Sponsor
- Alcon Research · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine whether nepafenac is safe and effective for reducing the incidence of macular edema following cataract surgery in diabetic retinopathy patients.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Nepafenac ophthalmic suspension, 0.1% (NEVANAC) | 1 drop TID beginning the day before surgery, continuing on the day of surgery and through the first 90 days following surgery. |
| OTHER | Nepafenac ophthalmic suspension vehicle | 1 drop TID beginning the day before surgery, continuing on the day of surgery and through the first 90 days following surgery |
| DRUG | Prednisolone acetate ophthalmic suspension (OMNIPRED) | One drop in the study eye 4 times daily (morning, late morning, late afternoon, and bedtime)for two weeks postsurgery. |
Timeline
- Start date
- 2008-11-01
- Primary completion
- 2010-07-01
- Completion
- 2010-07-01
- First posted
- 2008-10-31
- Last updated
- 2012-10-26
- Results posted
- 2011-09-21
Source: ClinicalTrials.gov record NCT00782717. Inclusion in this directory is not an endorsement.