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Difluprednate Pediatric Study for the Treatment of Inflammation Post-Cataract Surgery

NCT01124045 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2013-06-19

Study results available
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Summary

The primary objective of this study was to compare the safety and efficacy of Durezol™ compared to Pred Forte™ for the treatment of inflammation following cataract surgery in a pediatric population 0 to 3 years of age.

Conditions

Interventions

DRUG

Difluprednate ophthalmic emulsion, 0.05%

Topical ocular administration

DRUG

Prednisolone acetate ophthalmic suspension, 1.0%

Topical ocular administration

Sponsors & Collaborators

  • Alcon Research

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2012-04-30
Completion
2012-04-30

Countries

  • United States

Study Locations

More Related Trials

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 NCT01124045 on ClinicalTrials.gov