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Study of Difluprednate Ophthalmic Emulsion in the Treatment of Postoperative Inflammation

This study has been completed.
Sponsor:
Information provided by:
Sirion Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00406497
First received: November 29, 2006
Last updated: NA
Last verified: November 2006
History: No changes posted
  Purpose

The purpose of this phase 2 study is to determine if difluprednate ophthalmic emulsion is effective in the treatment of postoperative inflammation.


Condition Intervention Phase
Inflammation
 Drug: Difluprednate Ophthalmic Emulsion
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Phase 2a Study of 0.05% Difluprednate Ophthalmic Emulsion in the Treatment of Postoperative Inflammation

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • The variation from baseline in anterior chamber cell score on Day 14 (difference from baseline
  • score) was compared between the test and control groups.

Secondary Outcome Measures:
  • The variations from baseline in anterior chamber cell score on Days 3 and 7 were compared
  • between the test and control groups.
  • The numbers of patients with an anterior chamber cell score of 0 on Days 7 and 14 were
  • compared between the test and control groups.
  • The variations from baseline in anterior chamber flare score on Days 3, 7 and 14 were
  • The variations from baseline in total sign and symptom scores on Days 3, 7 and 14 were

Estimated Enrollment: 24
Study Start Date: April 2003
Estimated Study Completion Date: July 2003
Detailed Description:

The objective is to assess efficacy endpoints in comparison with 0.1% BM ophthalmic solution, prior to investigation of the efficacy and safety of 0.05% DFBA ophthalmic emulsion in the treatment of postoperative intraocular inflammation.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing intraocular surgery (cataract surgery, cataract surgery + implantation of intraocular lens, vitreous surgery, cataract surgery + implantation of intraocular lens + vitreous surgery)
  • Patients with anterior chamber cell score ≥2 on the next day of surgery
  • Male and female patients aged ≥20 years (on the day of obtaining informed consent)
  • Patients giving written informed consent prior to initiation of the study

Exclusion Criteria:

  • Patients who did not meet all of the above inclusion criteria
  • Patients receiving systemic administration of any corticosteroid or immunosuppressive drug, or topical application of corticosteroid ophthalmic ointment within 1 week before instillation of the investigational product
  • Patients receiving topical injection of any corticosteroid in eyes before instillation of the investigational product (aqueous preparation: within 1 week before instillation of the investigational product, depot preparation: within 2 weeks before instillation of the investigational product)
  • Patients receiving systemic administration of any non-steroidal anti-inflammatory drug or antiphlogistic enzyme
  • Patients receiving instillation of any corticosteroid, non-steroidal anti-inflammatory ophthalmic solution or antiphologistic enzyme within 24 hours before ophthalmic examination prior to instillation of the investigational product (on the next day of surgery) (except instillation of non-steroidal anti-inflammatory ophthalmic solution at 3, 2, 1 and 0.5 hours before surgery)
  • Patients with endogenous uveitis
  • Patients planning to undergo surgery of the contralateral eye during the study period
  • Patients with new intraocular bleeding after surgery
  • Patients receiving gas or silicon oil in the vitreous body
  • Patients with glaucoma or ocular hypertension (IOP on the next day of surgery ≥25 mmHg)
  • Patients with superficial punctuate keratopathy or corneal ulcer
  • Patients with any viral, bacterial or fungal keratoconjunctival disease
  • Patients with allergy to any corticosteroid
  • Patients requiring use of contact lens during the study period
  • Women who were or might be pregnant, or lactating women
  • Patients participating in another clinical study within 3 months before initiation of the present study
  • Patients undergoing surgery under systemic anesthesia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00406497

Sponsors and Collaborators
Sirion Therapeutics, Inc.
Investigators
Study Chair: Shigeaki Ohno Professor, Department of Ophthalmology and Visual Science, Graduate School of Medicine, Hokkaido University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00406497     History of Changes
Other Study ID Numbers: SJE2079/2-03-PC
Study First Received: November 29, 2006
Last Updated: November 29, 2006
Health Authority: Japan: Institutional Review Board

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