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

Alcon

Status and phase: Completed; Phase 3

Conditions: Endogenous Anterior Uveitis

Treatments: Drug: Prednisolone acetate 1.0% ophthalmic suspension; Drug: Difluprednate 0.05% ophthalmic emulsion

Study type: Interventional

Funder types: Industry

Identifiers

NCT01201798

C-10-034

Details and patient eligibility

About

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.

Enrollment: 111 patients

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

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.
• Other protocol-defined inclusion criteria may apply.

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.
• Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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111 participants in 2 patient groups

Durezol

Experimental group

Description:

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

Treatment:

Drug: Difluprednate 0.05% ophthalmic emulsion

Pred Forte

Active Comparator group

Description:

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

Treatment:

Drug: Prednisolone acetate 1.0% ophthalmic suspension