DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Alcon Research
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Endogenous Anterior Uveitis

Intervention: Difluprednate 0.05% ophthalmic emulsion (Drug); Prednisolone acetate 1.0% ophthalmic suspension (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Alcon Research

Summary

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.

Clinical Details

Official title: A Phase 3 Multicenter, Randomized, Double-Masked Study of the Safety and Efficacy of Difluprednate 0.05% Ophthalmic Emulsion Compared to Prednisolone Acetate 1% Ophthalmic Suspension in the Treatment of Endogenous Anterior Uveitis

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Change From Baseline (Day 0) in Anterior Chamber Cell Grade at Day 14

Secondary outcome:

Change From Baseline (Day 0) in Anterior Chamber Cell Grade at All Time Points Other Than Day 14

Change From Baseline (Day 0) in Anterior Chamber Flare Grade at All Time Points

Proportion of Subjects With Anterior Chamber Cell Grade of 0

Proportion of Subjects With Anterior Chamber Cell Count of 0

Proportion of Subjects With Anterior Chamber Cell Count ≤5 and Flare Grade of 0

Proportion of Subjects With Anterior Chamber Cell Grade ≤1

Proportion of Subjects Who Discontinued Due to Lack of Efficacy

Change From Baseline (Day 0) in Visual Analog Scale (VAS) Total Symptom Score at All Time Points

Change From Baseline (Day 0) in Slit-Lamp Total Sign Score at All Visits

Eligibility

Minimum age: 2 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Contact Alcon Call Center, Fort Worth, Texas 76134, United States
Additional Information

Starting date: October 2010
Last updated: October 15, 2012

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017