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Study of Difluprednate Ophthalmic Emulsion in the Treatment of Postoperative Inflammation

Primary Purpose

Inflammation

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Difluprednate Ophthalmic Emulsion

About this trial

This is an interventional treatment trial for Inflammation

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

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 Outcome Measures

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

The variations from baseline in total sign and symptom scores on Days 3, 7 and 14 were

Full Information

NCT ID

NCT00406497

First Posted

November 29, 2006

Last Updated

November 29, 2006

Sponsor

Sirion Therapeutics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00406497

Brief Title

Study of Difluprednate Ophthalmic Emulsion in the Treatment of Postoperative Inflammation

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2006

Overall Recruitment Status

Completed

Study Start Date

April 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

July 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Sirion Therapeutics, Inc.

4. Oversight

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Inflammation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

24 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Difluprednate Ophthalmic Emulsion

Primary Outcome Measure Information:

Title

The variation from baseline in anterior chamber cell score on Day 14 (difference from baseline

Title

score) was compared between the test and control groups.

Secondary Outcome Measure Information:

Title

The variations from baseline in anterior chamber cell score on Days 3 and 7 were compared

Title

between the test and control groups.

Title

The numbers of patients with an anterior chamber cell score of 0 on Days 7 and 14 were

Title

compared between the test and control groups.

Title

The variations from baseline in anterior chamber flare score on Days 3, 7 and 14 were

Title

The variations from baseline in total sign and symptom scores on Days 3, 7 and 14 were

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shigeaki Ohno

Organizational Affiliation

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

Official's Role

Study Chair

12. IPD Sharing Statement

Learn more about this trial

Study of Difluprednate Ophthalmic Emulsion in the Treatment of Postoperative Inflammation

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