Nepafenac Once Daily for Macular Edema - Study 1

Last updated: June 23, 2016
Sponsor: Alcon Research
Overall Status: Completed

Phase

3

Condition

Eye Disorders/infections

Macular Edema

Diabetic Retinopathy

Treatment

N/A

Clinical Study ID

NCT01853072
C-12-067
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Planned cataract extraction by phacoemulsification with implantation of a posteriorchamber 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 withexpectation of improvement after surgery;

  • Understand and sign an informed consent document;

  • Other protocol-defined inclusion criteria may apply.

Exclusion

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 after randomization and prior to the Day 90postoperative study visit or through study exit;

  • Planned multiple procedures for the study eye during the cataract/intraocular lensimplantation surgery;

  • 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 urinepregnancy test at screening, are not willing to undergo a urine pregnancy test uponentering or exiting the study, intend to become pregnant during the study, or do notagree to use adequate birth control methods for the duration of the study;

  • Other protocol-defined exclusion criteria may apply.

Study Design

Total Participants: 881
Study Start date:
June 01, 2013
Estimated Completion Date:
May 31, 2015

Connect with a study center

  • Contact Alcon Call Center at 1-888-451-3937 for Trial Locations

    Fort Worth, Texas 76134
    United States

    Site Not Available

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