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Study of Difluprednate in the Treatment of Inflammation Following Ocular Surgery (ST-601A-002b)

This study has been completed.
Sponsor:
Information provided by:
Sirion Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00430092
First received: January 30, 2007
Last updated: May 12, 2009
Last verified: May 2009
History of Changes
  Purpose

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


Condition Intervention Phase
Inflammation
 Drug: Difluprednate
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sirion Therapeutics, Inc.:

Primary Outcome Measures:
  • Anterior Chamber Cell Grade of "0" on Day 8 (Difluprednate QID vs Placebo). [ Time Frame: Day 8 (QID) ] [ Designated as safety issue: No ]

Enrollment: 219
Arms Assigned Interventions
Experimental: Difluprednate 0.05% BID
Difluprednate 0.05% 1 drop BID for 14 days
 Drug: Difluprednate
Experimental: Difluprednate 0.05% QID
Difluprednate 0.05% 1 drop QID for 14 days
 Drug: Difluprednate
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.
 Drug: Placebo

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00430092

Locations
United States, Missouri
Comprehensive Eye Care
Washington, Missouri, United States, 63090
Sponsors and Collaborators
Sirion Therapeutics, Inc.
Investigators
Study Chair: Roger Vogel, MD Sirion Therapeutics, Inc.
  More Information

No publications provided by Sirion Therapeutics, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00430092     History of Changes
Other Study ID Numbers: ST-601A-002b
Study First Received: January 30, 2007
Results First Received: May 12, 2009
Last Updated: May 12, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Inflammation
Pathologic Processes
Difluprednate
Fluprednisolone
Glucocorticoids
Hormones
 Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013