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

NCT ID: NCT00616070

Last Updated: 2011-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2008-03-31

Brief Summary

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

Detailed Description

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Conditions

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Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Difluprednate

Group Type EXPERIMENTAL

Difluprednate

Intervention Type DRUG

Difluprednate

2

Vehicle

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Vehicle

Interventions

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Difluprednate

Difluprednate

Intervention Type DRUG

Placebo

Vehicle

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sirion Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Sirion Therapeutics

Principal Investigators

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Roger Vogel, MD

Role: STUDY_CHAIR

Sirion Therapeutics

Locations

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Charlotte Eye, Ear, Nose & Throat

Charlotte, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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ST-601-003

Identifier Type: -

Identifier Source: org_study_id