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Nepafenac Once Daily for Macular Edema - Study 1

NCT01853072 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 881

Last updated 2016-08-03

Study results available
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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.

Conditions

Interventions

DRUG

Nepafenac Ophthalmic Suspension, 0.3%

Test intervention

OTHER

Nepafenac vehicle

Inactive ingredients used as placebo comparator

DRUG

Prednisolone acetate

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

Sponsors & Collaborators

  • Alcon Research

    lead INDUSTRY

Principal Investigators

  • Clinical Project Lead GCRA, Pharma · Alcon Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2015-05-31
Completion
2015-05-31

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Entities

Diseases

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 NCT01853072 on ClinicalTrials.gov