Study of Difluprednate in the Treatment of Inflammation Following Ocular Surgery (ST-601-003)

Sirion Therapeutics, Inc.120 enrolled

Overview

The purpose of this phase III study is to determine the safety and efficacy of difluprednate in the management of inflammation following ocular surgery.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

120

Conditions

Inflammation

Interventions

DifluprednateDRUG

Difluprednate

PlaceboOTHER

Vehicle

Eligibility

Sex: ALLMin age: 2 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Scheduled for unilateral ocular surgery. Exclusion Criteria: * Systemic administration of any corticosteroid or immunosuppressive drug in the 2 weeks prior to study enrollment.

Locations (1)

Charlotte Eye, Ear, Nose & Throat

Charlotte, North Carolina, United States

Outcomes

Primary Outcomes

The proportion of subjects with an anterior chamber cell grade of "0" and a flare grade of "0" on Day 14, compared between difluprednate and placebo groups

Time frame: Day 14

Secondary Outcomes

The proportion of subjects with an anterior chamber cell grade of "0" and a flare grade of "0" on Day 7, compared between difluprednate and placebo groups.

Time frame: Day 7

Data from ClinicalTrials.gov

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