Study of Difluprednate in the Treatment of Inflammation Following Ocular Surgery (ST-601A-002a)
May 12, 2009 updated by: Sirion Therapeutics, Inc.
A Phase 3 Multicenter, Randomized, Double-Masked, Placebo-Controlled Study of the Safety and Efficacy of Difluprednate in the Treatment of Inflammation Following Ocular Surgery
The purpose of this phase III study is to determine the efficacy of difluprednate in the treatment of inflammation following ocular surgery.
Study Overview
Study Type
Interventional
Enrollment (Actual)
219
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Missouri
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Washington, Missouri, United States, 63090
- Comprehensive Eye Care
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Unilateral ocular surgery in the day prior to study enrollment.
- Anterior chamber cell grade ≥ "2" on the day after surgery (Day 1).
- Aged 2 years or older on the day of consent.
- Negative urine pregnancy test on Day 1 for postmenarchal subjects; negative urine pregnancy test for premenarchal subjects at the investigator's discretion.
- Provide signed written consent prior to entering the study or signed written consent from parent or legal guardian if subject is a minor and signed assent from minor subject, if appropriate.
Presurgical Exclusion Criteria:
- Systemic administration of any corticosteroid in the 2 weeks prior to study enrollment.
- Periocular injection in the study eye of any corticosteroid solution within 4 weeks prior to instillation of the study drug, or of any corticosteroid depot within 2 months prior to instillation of the study drug.
- Instillation of any topical ocular corticosteroid or NSAID within 24 hours prior to instillation of the study drug or during the course of the study, with the exception of presurgical administration of a topical NSAID to prevent miosis.
- Any history of glaucoma or ocular hypertension in the study eye.
- History or presence of endogenous uveitis.
- Any current corneal abrasion or ulceration.
- Any confirmed or suspected active viral, bacterial, or fungal keratoconjunctival disease.
- Allergy to similar drugs, such as other corticosteroids.
- History of steroid-related IOP increase.
- Scheduled surgery on the contralateral eye during the treatment period.
- Unwilling to discontinue use of contact lenses during the study period.
- Pregnancy or lactation.
- Participation in any study of an investigational topical or systemic new drug or device within 30 days prior to screening, or at any time during the study.
- Prior participation in the study described in this protocol.
- Unable or unwilling to give signed informed consent prior to participation in any study related procedures.
Postsurgical Exclusion Criteria:
- Ocular hemorrhage which interferes with evaluation of postsurgery inflammation.
- Injection of gas into the vitreous body during surgery.
- Presence of IOP ≥24 mm Hg on Day 1 after surgery.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Placebo Comparator: Placebo
Placebo for 14 days.
Placebo was administered BID for 14 days and QID for 14 days.
The outcomes of the 2 placebo groups were examined and were determined to be statistically indistinguishable so the placebo groups were pooled for comparison with the difluprednate groups.
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Experimental: Difluprednate 0.05% BID
Difluprednate 0.05% 1 drop BID for 14 days.
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Experimental: Difluprednate 0.05% QID
Difluprednate 0.05% 1 drop QID for 14 days.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Anterior Chamber Cell Grade of "0" on Day 8 (Difluprednate QID vs Placebo).
Time Frame: Day 8 (QID)
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Measured on a 0 to 4 scale: "0" is ≤ 1 cell; "1" is 2-10 cells; "2" is 11-20 cells; "3" is 21-50 cells; "4" is > 50 cells.
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Day 8 (QID)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Roger Vogel, MD, Sirion Therapeutics, Inc.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
January 31, 2007
First Submitted That Met QC Criteria
January 31, 2007
First Posted (Estimate)
February 1, 2007
Study Record Updates
Last Update Posted (Estimate)
July 2, 2009
Last Update Submitted That Met QC Criteria
May 12, 2009
Last Verified
May 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ST-601A-002a
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.