Study of Difluprednate Ophthalmic Emulsion in the Treatment of Postoperative Inflammation

NCT ID: NCT00407225

Last Updated: 2006-12-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-12-31
• Study Completion Date: 2000-10-31

Brief Summary

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

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.

Conditions

Inflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Difluprednate Ophthalmic Emulsion

Intervention Type: DRUG

Eligibility Criteria

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)

• 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)

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sirion Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Principal Investigators

Kanjiro Masuda

Role: STUDY_CHAIR

Director, Kanto Rosai Hospital; Director, Japanese Red Cross Medical Center

Other Identifiers

SJE2079/2-01-PC

Identifier Type: -

Identifier Source: org_study_id