Study of Difluprednate Ophthalmic Emulsion in the Treatment of Postoperative Inflammation

December 5, 2006 updated by: Sirion Therapeutics, Inc.

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

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 the efficacy and safety of 0.002% and 0.05% difluprednate ophthalmic emulsions in patients with postoperative inflammation after cataract surgery (implantation of intraocular lens). In addition, the evaluation system for a future dose-finding phase III study of difluprednate ophthalmic emulsion will be established.

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

12 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with a mean postoperative (on the day of surgery or the day after surgery) flare intensity of 30 photon counts/msec
  • Male and female patients aged 12 and <75 years who were able to accurately express their own symptoms
  • Patients providing written informed consent prior to the start of the study
  • Inpatients (patients were allowed to be discharged from the hospital during the study period)

Exclusion Criteria:

  • Patients who did not meet any of the above inclusion criteria
  • Patients receiving systemic administration, or topical application to the head or face (including instillation to the eyes) of any steroid, nonsteroidal anti-inflammatory drug, antiphlogistic enzyme, immunosuppressive drug or colchicine within 1 week prior to the start of the study treatment
  • Patients with glaucoma or ocular hypertension (IOP: 21 mmHg)
  • Patients with corneal abrasion or ulcer
  • Patients with any viral keratoconjunctival disease, tuberculosus eye disease, fungal eye disease or bacterial eye disease

  • Patients with diabetes who met any of the following criteria

    • HbA1C was 9.0% within 1 month prior to obtaining informed consent.
    • Proliferative diabetic retinopathy was present.
    • Rubeosis iridis was present.
  • Patients with allergy to steroids
  • Patients requiring the use of contact lens during the study period
  • Women who were or might be pregnant
  • Patients participating in another clinical study within 6 months prior to the start of the present study
  • Patients sensitive to steroids (patients who previously experienced increased IOP after instillation of a steroid)
  • Patients with a Grade 5 nuclear hardness as diagnosed according to Emery-Little classification
  • Patients with fibrins or posterior rupture at baseline (F0)

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 flare intensity on Day 72 (F7) was compared with the baseline flare intensity (F0).
The ratios of the flare intensity on Day 1 (F1), that on Day 31 (F3) and that on Day 72 (F7) to
the baseline flare intensity (F0) (F1/F0, F3/F0 and F7/F0, respectively) were determined. Each
ratio was compared between the 0.002% and 0.05% difluprednate groups to identify when the
between-group difference in the effect of difluprednate became significant.

Secondary Outcome Measures

Outcome Measure
between-group difference in the effect of difluprednate became significant.
The total score of anterior chamber signs (cells and protein) on Day 72 (S7) was compared
with the baseline total score (S0).
As the secondary efficacy evaluation, the ratios of the total score of anterior chamber signs
(cells and protein) on Day 1 (S1), that on Day 31 (S3) and that on Day 72 (S7) to the baseline
total score (S0) (S1/S0, S3/S0 and S7/S0, respectively) were determined. Each ratio was
compared between the 0.002% and 0.05% difluprednate groups to identify when the

Collaborators and Investigators

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

Sponsor

Sirion Therapeutics, Inc.

Investigators

  • Study Chair: Kanjiro Masuda, Director, Kanto Rosai Hospital; Director, Japanese Red Cross Medical Center

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

December 1, 1999

Study Completion

October 1, 2000

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 6, 2006

Last Update Submitted That Met QC Criteria

December 5, 2006

Last Verified

November 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SJE2079/2-01-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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