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Clinical Endpoint Study of Nepafenac 0.3% Opthalmic Suspension

NCT03499873 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 448

Last updated 2021-02-16

Study results available
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Summary

A randomized, multicenter, double masked, placebo controlled, parallel group, bioequivalence study to evaluate the clinical equivalence and safety of Nepafenac 0.3% ophthalmic suspension (manufactured by Indoco remedies Ltd. for Actavis LLC) with IlevroTM (Nepafenac ophthalmic suspension), 0.3% of Alcon Laboratories, Inc. for the treatment of pain and inflammation associated with cataract surgery.

Conditions

  • Cataract

Interventions

DRUG

Nepafenac 0.3% Oph Susp

Nepafenac 0.3% Ophthalmic suspension (experimental product)

DRUG

Placebos

Placebo

DRUG

Nepafenac 0.3% Oph Susp (reference)

Nepafenac 0.3% Ophthalmic suspension (Innovator)

Sponsors & Collaborators

  • Actavis Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-28
Primary Completion
2018-10-31
Completion
2018-12-18
FDA Drug
Yes

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 NCT03499873 on ClinicalTrials.gov