Study of Difluprednate Ophthalmic Emulsion in the Treatment of Postoperative Inflammation

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00406497
• Other study ID #: SJE2079/2-03-PC
• Status: Completed
• Phase: Phase 2
• First received: November 29, 2006
• Last updated: November 29, 2006
• Start date: April 2003
• Est. completion date: July 2003

Study information

• Verified date: November 2006
• Source: Sirion Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Description:

The objective is to assess efficacy endpoints in comparison with 0.1% BM ophthalmic solution, prior to investigation of the efficacy and safety of 0.05% DFBA ophthalmic emulsion in the treatment of postoperative intraocular inflammation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Patients who did not meet all of the above inclusion criteria

• 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

• Patients undergoing surgery under systemic anesthesia

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Inflammation

Intervention

Drug:
• Difluprednate Ophthalmic Emulsion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sirion Therapeutics, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The variation from baseline in anterior chamber cell score on Day 14 (difference from baseline
Primary	score) was compared between the test and control groups.
Secondary	The variations from baseline in anterior chamber cell score on Days 3 and 7 were compared
Secondary	between the test and control groups.
Secondary	The numbers of patients with an anterior chamber cell score of 0 on Days 7 and 14 were
Secondary	compared between the test and control groups.
Secondary	The variations from baseline in anterior chamber flare score on Days 3, 7 and 14 were
Secondary	The variations from baseline in total sign and symptom scores on Days 3, 7 and 14 were