Study of Difluprednate Ophthalmic Emulsion in the Treatment of Postoperative Inflammation - Full Text View

Sponsored by:	Sirion Therapeutics, Inc.
Information provided by:	Sirion Therapeutics, Inc.
ClinicalTrials.gov Identifier:	NCT00406497

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 II

Drug Information available for: Difluprednate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase 2a Study of 0.05% Difluprednate Ophthalmic Emulsion in the Treatment of Postoperative Inflammation

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

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

Study placed in the following topic categories:

Inflammation

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009