Skip to main content
OpenTrials
Completed

NCT Number: NCT01853072

Nepafenac Once Daily for Macular Edema - Study 1

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.

Completed

Looking for future studies?

Notify Me

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 after randomization and prior to the Day 90 postoperative study visit or through study exit;
  • Planned multiple procedures for the study eye during the cataract/intraocular lens implantation 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 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.

Treatment and study plan

Nepafenac Ophthalmic Suspension, 0.3%

Drug

Test intervention

Other names: Nepafenac

Nepafenac Vehicle

Other

Inactive ingredients used as placebo comparator

Prednisolone Acetate

Drug

1 drop instilled in the operative eye 4 times daily beginning post-operatively on the day of surgery for the first 2 weeks, followed by 2 times daily for the next 2 weeks

Other names: Omnipred™, Prednisolone acetate ophthalmic suspension

Primary outcomes

  1. Percentage of Participants With Best-corrected Visual Acuity (BCVA) Improvement of ≥ 15 Letters From Preoperative Baseline to Day 14 and Maintained Through Day 90

    Time frame: Baseline to Day 14, and maintained through Day 90

    BCVA (with spectacles or other visual corrective devices) was reported in letters read correctly, using the Early Treatment Diabetic Retinopathy Study (ETDRS) test of 70 letters. Improvement of BCVA was defined as an increase (gain) in the number of letters read, compared to the baseline assessment. One eye (study eye) contributed to the analysis.

  2. Percentage of Participants Who Develop Macular Edema Within 90 Days Following Cataract Surgery (Day 0)

    Time frame: Day 0 to Day 90

    Macular edema was defined as ≥ 30% Increase from pre-operative baseline in central subfield macular thickness, as measured with Spectral Domain Ocular Coherence Tomography (SD-OCT). One eye (study eye) contributed to the analysis.

Secondary outcomes

  1. Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 90

    Time frame: Baseline to Day 90

  2. Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 60

    Time frame: Baseline to Day 60

  3. Percentage of Participants With a > 5-letter Loss in BCVA From Day 7 to Any Visit [Time Frame: Day 7 up to Any Visit]

    Time frame: Day 7 up to any visit through Day 90

  4. Percentage of Participants With With a > 10-letter Loss in BCVA From Day 7 to Any Visit

    Time frame: Day 7 up to any visit through Day 90

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
May 14, 2013
Registry last updated
Aug 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.