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Safety and Efficacy of Difluprednate 0.05% for the Treatment of Anterior Uveitis

NCT ID: NCT01201798

Last Updated: 2012-11-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

111 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-08-31

Brief Summary

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The purpose of this study was to demonstrate that difluprednate 0.05% (Durezol) dosed 4 times daily is noninferior to prednisolone 1% (Pred Forte) dosed 8 times daily for the treatment of endogenous anterior uveitis.

Detailed Description

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Conditions

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Endogenous Anterior Uveitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Durezol

Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period

Group Type EXPERIMENTAL

Difluprednate 0.05% ophthalmic emulsion

Intervention Type DRUG

1 drop in study eye, 4 times a day, for 14 days, followed by a 14-day tapering period dependent on the Investigator's determination of adequate response to treatment

Pred Forte

Prednisolone acetate 1.0% ophthalmic suspension, 1 drop in study eye, 8 times a day for 14 days, followed by a 14-day tapering period

Group Type ACTIVE_COMPARATOR

Prednisolone acetate 1.0% ophthalmic suspension

Intervention Type DRUG

1 drop in study eye, 8 times a day, for 14 days, followed by a 14-day tapering period dependent on the Investigator's determination of adequate response to treatment

Interventions

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Difluprednate 0.05% ophthalmic emulsion

1 drop in study eye, 4 times a day, for 14 days, followed by a 14-day tapering period dependent on the Investigator's determination of adequate response to treatment

Intervention Type DRUG

Prednisolone acetate 1.0% ophthalmic suspension

1 drop in study eye, 8 times a day, for 14 days, followed by a 14-day tapering period dependent on the Investigator's determination of adequate response to treatment

Intervention Type DRUG

Other Intervention Names

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Durezol Pred Forte

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of endogenous anterior uveitis in at least 1 eye.
* The presence of \> 10 cells in the anterior chamber of at least one eye, and a flare score of \> 2 in that same eye.
* Age 2 years or older on day of consent.
* Negative urine pregnancy test on Day 0 for females of childbearing potential who are not at least 1 year post-menopausal or surgically sterilized.

Exclusion Criteria

* Presence of endogenous anterior uveitis diagnosed for \> 2 weeks prior to enrollment in the study.
* Presence of intermediate uveitis, posterior uveitis or panuveitis in either eye.
* Instillation of any topical corticosteroid or NSAID in the study eye within 7 days of instillation of study drug.
* History of glaucoma or clinically significant ocular hypertension in the opinion of the Investigator involving an IOP ≥ 21 millimeters mercury in either eye.
* History of steroid-induced elevation of intraocular pressure.
* Any confirmed or suspected active viral, bacterial or fungal keratoconjunctival disease in either eye.
* History of glaucoma or clinically significant ocular hypertension in the opinion of the Investigator involving an intraocular pressure (IOP) \> 21 mmHg in either eye.
* Corneal abrasion or ulceration in either eye.
* Pregnancy or lactation.
Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Contact Alcon Call Center

Fort Worth, Texas, United States

Site Status

Countries

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United States

References

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Sheppard JD, Toyos MM, Kempen JH, Kaur P, Foster CS. Difluprednate 0.05% versus prednisolone acetate 1% for endogenous anterior uveitis: a phase III, multicenter, randomized study. Invest Ophthalmol Vis Sci. 2014 May 6;55(5):2993-3002. doi: 10.1167/iovs.13-12660.

Reference Type DERIVED
PMID: 24677110 (View on PubMed)

Other Identifiers

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C-10-034

Identifier Type: -

Identifier Source: org_study_id