Study of Difluprednate Ophthalmic Emulsion in the Treatment of Postoperative Inflammation

NCT00406497 | Completed Phase 2

• 1 other identifier: SJE2079/2-03-PC
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Inflammation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• 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

Interventions

Difluprednate Ophthalmic Emulsion DRUG

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sirion Therapeutics, Inc.: lead

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Shigeaki Ohno

  Professor, Department of Ophthalmology and Visual Science, Graduate School of Medicine, Hokkaido University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 29, 2006
• First Posted: December 4, 2006
• Study Start: April 1, 2003
• Study Completion: July 1, 2003
• Last Updated: December 4, 2006

Record last verified: 2006-11