Nepafenac Once Daily for Macular Edema - Study 2



Status:Completed
Conditions:Ocular, Diabetes
Therapuetic Areas:Endocrinology, Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:2/7/2015
Start Date:June 2013
End Date:April 2015
Contact:Alcon Call Center
Email:alcon.medinfo@alcon.com
Phone:1-888-451-3937

Use our guide to learn which trials are right for you!

Randomized, Double-Masked, Vehicle Controlled, Clinical Evaluation To Assess The Safety And Efficacy Of Nepafenac Ophthalmic Suspension, 0.3% For Improvement In Clinical Outcomes Among Diabetic Subjects Following Cataract Surgery

The purpose of this study is to demonstrate superiority of Nepafenac Ophthalmic Suspension,
0.3% dosed once daily relative to Nepafenac Vehicle based upon clinical outcomes among
diabetic subjects following cataract surgery.


Inclusion Criteria:

- Planned cataract extraction by phacoemulsification with implantation of a posterior
chamber intraocular lens;

- History of Type 1 or 2 diabetes and non-proliferative diabetic retinopathy (NPDR)
(mild, moderate, or severe) in the study eye;

- Best-corrected visual acuity (BCVA) of 73 letters or worse in the study eye with
expectation of improvement after surgery;

- Understand and sign an informed consent document;

- Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

- Pre-existing macular edema in the study eye;

- History in the study eye of retinal detachment, wet age-related macular degeneration,
chronic or recurrent inflammatory eye disease, or prior procedures;

- Planned cataract surgery in the fellow eye prior to the Day 90 postoperative study
visit or through study exit;

- Planned multiple procedures for the study eye during the cataract/intraocular lens;

- Use of exclusionary medications, including nonsteroidal anti-inflammatory drugs
(NSAIDs) and steroids, as specified in protocol.

- Participation in any other clinical study within 30 days of the screening visit;

- Females of childbearing potential who are breast feeding, have a positive urine
pregnancy test at screening, are not willing to undergo a urine pregnancy test upon
entering or exiting the study, intend to become pregnant during the study, or do not
agree to use adequate birth control methods for the duration of the study;

- Other protocol-defined exclusion criteria may apply.
We found this trial at
1
site
6201 South Freeway
Fort Worth, Texas 76134
800 862 5266
Alcon Call Center Alcon is helping people see the world better through advanced surgical, pharmaceutical...
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials