Study of Difluprednate Ophthalmic Emulsion in Postoperative Inflammation

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

Phase 3 Confimatory Study of 0.05% Difluprednate Ophthalmic Emulsion in the Treament of Postoperative Inflammation

The purpose of this phase 3 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 of this phase 3 study is to assess the efficacy and safety of 0.05% difluprednate ophthalmic emulsion in patients with intraocular postoperative inflammation.

Study Type

Interventional

Enrollment

200

Phase

  • Phase 3

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 who have undergone cataract surgery, vitreous surgery or both (including patients who have undergone IOL insertion surgery at the same time)
  • Patients showing an anterior chamber cell score of not less than "2" at a day after surgery
  • Patients aged 20 years or over, irrespective of genders (it is eligible for enrollment when patients' age attains the criterion on the day of consent obtainment)

Exclusion Criteria:

  • Patients who took systemic administration of corticosteroids or immunosuppressive agents, or used ophthalmic ointments of corticosteroids within 1 week before instillation of the investigational drugs;
  • Patients who underwent local injection of corticosteroids in the eyes before instillation of the investigational drugs; (patients who used aqueous preparations within 1 week or patient who used depot preparations within 2 weeks were excluded)
  • Patients who took systemic administration of non-steroidal antiinflammatory agents or antiinflammatory enzyme preparations within 3 days before instillation of the investigational drugs;
  • Patients who instilled of corticosteroids, no-steroidal antiinflammatory agents or antiinflammatory enzyme preparations within 24 hours before the pre-instillation observation (a day after surgery);
  • Patients who underwent perioperative and/or postoperative intravitreous injection of corticosteroids;
  • Patients who underwent sub-conjunctival injection or sub-Tenon capsule injection of corticosteroids;
  • Patients who have intraocular hemorrhage with a degree that may affect the postoperative evaluations;
  • Patients who underwent gas tamponade at the surgery;
  • Patients with endogenous uveitis;
  • Patients having corneal epithelial detachment or corneal ulcer in the target eye;
  • Patients who are suspected of having viral, bacterial or mycotic keratoconjunctival disorders in the target or opposite eye;
  • Patients with glaucoma or ocular hypertension, or those with past history of IOP increased due to instillation of corticosteroids, or those whose IOP has been controlled by use of ophthalmic antihypertensive agents;
  • Patients showing IOP not less than 25 mmHg a day after surgery;
  • Patients who have allergy to corticosteroid drugs;
  • Patients who are required to wear contact lens during the study period;
  • Patients who are scheduled to undergo surgery of the opposite eye during the study period;
  • Patients who are pregnant or may be pregnant or lactating;
  • Patients who have participated in other clinical studies within 3 months.

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 Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The changes in anterior chamber cell score at day 14 after start of instillation from the baseline level (differences from the baseline score) were compared between the 2 treatment groups.

Secondary Outcome Measures

Outcome Measure
The changes in anterior chamber cell score at days 3 and 7 after start of instillation were compared between the 2 treatment groups.
The numbers of patients showing an anterior chamber cell score of "0" at days 3, 7 and 14 after start of instillation were compared between the 2 treatment groups.
The changes in anterior chamber flare score at days 3, 7 and 14 after start of instillation (difference from the baseline score) were compared between the 2 treatment groups.
The changes in the total scores of subjective symptoms and objective signs at days 3, 7 and 14 after start of instillation (difference from the baseline score) were compared between the 2 treatment groups.

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, Department of Ophthalmology and Visual Sciences, 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, 2004

Study Completion

March 1, 2005

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

  • SJE2079/3-03

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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