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A Clinical Safety and Efficacy Comparison of NEVANAC 0.1% to Vehicle After Cataract Surgery in Diabetic Retinopathy Patients

NCT00782717 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 263

Last updated 2012-10-26

Study results available
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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

  • Macular Edema

Interventions

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.

Sponsors & Collaborators

  • Alcon Research

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2010-07-31
Completion
2010-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00782717 on ClinicalTrials.gov