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Study of Difluprednate in the Treatment of Inflammation Following Ocular Surgery (ST-601A-002b)

Primary Purpose

Inflammation

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Difluprednate

Placebo

About this trial

This is an interventional treatment trial for Inflammation

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All Sexes

Inclusion Criteria:

Unilateral ocular surgery in the day prior to study enrollment.
Anterior chamber cell grade ≥ "2" on the day after surgery (Day 1).
Aged 2 years or older on the day of consent.
Negative urine pregnancy test on Day 1 for postmenarchal subjects; negative urine pregnancy test for premenarchal subjects at the investigator's discretion.
Provide signed written consent prior to entering the study or signed written consent from parent or legal guardian if subject is a minor and signed assent from minor subject, if appropriate.

Presurgical Exclusion Criteria:

Systemic administration of any corticosteroid in the 2 weeks prior to study enrollment.
Periocular injection in the study eye of any corticosteroid solution within 4 weeks prior to instillation of the study drug, or of any corticosteroid depot within 2 months prior to instillation of the study drug.
Instillation of any topical ocular corticosteroid or NSAID within 24 hours prior to instillation of the study drug or during the course of the study, with the exception of presurgical administration of a topical NSAID to prevent miosis.
Any history of glaucoma or ocular hypertension in the study eye.
History or presence of endogenous uveitis.
Any current corneal abrasion or ulceration.
Any confirmed or suspected active viral, bacterial, or fungal keratoconjunctival disease.
Allergy to similar drugs, such as other corticosteroids.
History of steroid-related IOP increase.
Scheduled surgery on the contralateral eye during the treatment period.
Unwilling to discontinue use of contact lenses during the study period.
Pregnancy or lactation.
Participation in any study of an investigational topical or systemic new drug or device within 30 days prior to screening, or at any time during the study.
Prior participation in the study described in this protocol.
Unable or unwilling to give signed informed consent prior to participation in any study related procedures.

Postsurgical Exclusion Criteria:

Ocular hemorrhage which interferes with evaluation of postsurgery inflammation.
Injection of gas into the vitreous body during surgery.
Presence of IOP ≥24 mm Hg on Day 1 after surgery.

Sites / Locations

Comprehensive Eye Care

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Difluprednate 0.05% BID

Difluprednate 0.05% QID

Placebo

Arm Description

Difluprednate 0.05% 1 drop BID for 14 days

Difluprednate 0.05% 1 drop QID for 14 days

Placebo for 14 days. Placebo was administered BID for 14 days and QID for 14 days. The outcomes of the 2 placebo groups were examined and were determined to be statistically indistinguishable so the placebo groups were pooled for comparison with the difluprednate groups.

Outcomes

Primary Outcome Measures

Anterior Chamber Cell Grade of "0" on Day 8 (Difluprednate QID vs Placebo).

Measured on a 0 to 4 scale: "0" is ≤ 1 cell; "1" is 2-10 cells; "2" is 11-20 cells; "3" is 21-50 cells; "4" is > 50 cells.

Secondary Outcome Measures

Full Information

NCT ID

NCT00430092

First Posted

January 30, 2007

Last Updated

May 12, 2009

Sponsor

Sirion Therapeutics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00430092

Brief Title

Study of Difluprednate in the Treatment of Inflammation Following Ocular Surgery (ST-601A-002b)

Official Title

A Phase 3 Multicenter, Randomized, Double-Masked, Placebo-Controlled Study of the Safety and Efficacy of Difluprednate in the Treatment of Inflammation Following Ocular Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

May 2009

Overall Recruitment Status

Completed

Study Start Date

undefined (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Sirion Therapeutics, Inc.

4. Oversight

5. Study Description

Brief Summary

The purpose of this phase III study is to determine the efficacy of difluprednate in the treatment of inflammation following ocular surgery.

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 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

219 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Difluprednate 0.05% BID

Arm Type

Experimental

Arm Description

Difluprednate 0.05% 1 drop BID for 14 days

Arm Title

Difluprednate 0.05% QID

Arm Type

Experimental

Arm Description

Difluprednate 0.05% 1 drop QID for 14 days

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Difluprednate

Intervention Type

Drug

Intervention Name(s)

Difluprednate

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Anterior Chamber Cell Grade of "0" on Day 8 (Difluprednate QID vs Placebo).

Description

Measured on a 0 to 4 scale: "0" is ≤ 1 cell; "1" is 2-10 cells; "2" is 11-20 cells; "3" is 21-50 cells; "4" is > 50 cells.

Time Frame

Day 8 (QID)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Eligibility Criteria

Inclusion Criteria: Unilateral ocular surgery in the day prior to study enrollment. Anterior chamber cell grade ≥ "2" on the day after surgery (Day 1). Aged 2 years or older on the day of consent. Negative urine pregnancy test on Day 1 for postmenarchal subjects; negative urine pregnancy test for premenarchal subjects at the investigator's discretion. Provide signed written consent prior to entering the study or signed written consent from parent or legal guardian if subject is a minor and signed assent from minor subject, if appropriate. Presurgical Exclusion Criteria: Systemic administration of any corticosteroid in the 2 weeks prior to study enrollment. Periocular injection in the study eye of any corticosteroid solution within 4 weeks prior to instillation of the study drug, or of any corticosteroid depot within 2 months prior to instillation of the study drug. Instillation of any topical ocular corticosteroid or NSAID within 24 hours prior to instillation of the study drug or during the course of the study, with the exception of presurgical administration of a topical NSAID to prevent miosis. Any history of glaucoma or ocular hypertension in the study eye. History or presence of endogenous uveitis. Any current corneal abrasion or ulceration. Any confirmed or suspected active viral, bacterial, or fungal keratoconjunctival disease. Allergy to similar drugs, such as other corticosteroids. History of steroid-related IOP increase. Scheduled surgery on the contralateral eye during the treatment period. Unwilling to discontinue use of contact lenses during the study period. Pregnancy or lactation. Participation in any study of an investigational topical or systemic new drug or device within 30 days prior to screening, or at any time during the study. Prior participation in the study described in this protocol. Unable or unwilling to give signed informed consent prior to participation in any study related procedures. Postsurgical Exclusion Criteria: Ocular hemorrhage which interferes with evaluation of postsurgery inflammation. Injection of gas into the vitreous body during surgery. Presence of IOP ≥24 mm Hg on Day 1 after surgery.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Roger Vogel, MD

Organizational Affiliation

Sirion Therapeutics, Inc.

Official's Role

Study Chair

Facility Information:

Facility Name

Comprehensive Eye Care

City

Washington

State/Province

Missouri

ZIP/Postal Code

63090

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

19101421

Citation

Korenfeld MS, Silverstein SM, Cooke DL, Vogel R, Crockett RS; Difluprednate Ophthalmic Emulsion 0.05% (Durezol) Study Group. Difluprednate ophthalmic emulsion 0.05% for postoperative inflammation and pain. J Cataract Refract Surg. 2009 Jan;35(1):26-34. doi: 10.1016/j.jcrs.2008.09.024.

Results Reference

derived

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Study of Difluprednate in the Treatment of Inflammation Following Ocular Surgery (ST-601A-002b)

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