Study of Difluprednate Ophthalmic Emulsion in Postoperative Inflammation

NCT ID: NCT00406341

Last Updated: 2006-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-04-30
• Study Completion Date: 2005-03-31

Brief Summary

The purpose of this phase 3 study is to determine if difluprednate ophthalmic emulsion is effective in the treatment of postoperative inflammation.

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.

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 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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sirion Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Principal Investigators

Shigeaki Ohno

Role: STUDY_CHAIR

Department of Ophthalmology and Visual Sciences, Graduate School of Medicine, Hokkaido University

Other Identifiers

SJE2079/3-03

Identifier Type: -

Identifier Source: org_study_id