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Confirmatory Study Nepafenac 0.3%

NCT01109173 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2120

Last updated 2012-11-30

Study results available
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Summary

The purpose of this study was to assess the safety and efficacy of an investigational eye drop intended for the prevention and treatment of inflammation (swelling and redness) and pain in the eye after cataract extraction.

Conditions

  • Cataract

Interventions

DRUG

Nepafenac Ophthalmic Suspension, 0.3%

Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily, for 16 days. An additional dose was administered between 30-120 minutes prior to surgery.

DRUG

Nepafenac Ophthalmic Suspension, 0.1%

Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye three times daily, for 16 days

OTHER

Nepafenac Ophthalmic Suspension 0.3% Vehicle

Nepafenac 0.3% vehicle, one drop in affected eye once daily, for 16 days. An additional dose was administered between 30-120 minutes prior to surgery.

OTHER

NEVANAC Vehicle

Nepafenac vehicle, one drop in affected eye three times daily, for 16 days

Sponsors & Collaborators

  • Alcon Research

    lead INDUSTRY

Principal Investigators

  • Dana Sager, MS · Alcon Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2011-05-31

Countries

  • United States

Study Locations

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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 NCT01109173 on ClinicalTrials.gov