Study of Difluprednate Ophthalmic Emulsion in the Treatment of Postoperative Inflammation

November 29, 2006 updated by: Sirion Therapeutics, Inc.

Phase 2a Study of 0.05% Difluprednate Ophthalmic Emulsion in the Treatment of Postoperative Inflammation

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

24

Phase

  • Phase 2

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

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sirion Therapeutics, Inc.

Investigators

  • Study Chair: Shigeaki Ohno, Professor, Department of Ophthalmology and Visual Science, Graduate School of Medicine, Hokkaido University

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 Major Dates

Study Start

April 1, 2003

Study Completion

July 1, 2003

Study Registration Dates

First Submitted

November 29, 2006

First Submitted That Met QC Criteria

November 29, 2006

First Posted (ESTIMATE)

December 4, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

December 4, 2006

Last Update Submitted That Met QC Criteria

November 29, 2006

Last Verified

November 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SJE2079/2-03-PC

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.

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