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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 30, 2014