Status:
COMPLETED
Safety and Efficacy of Difluprednate 0.05% for the Treatment of Anterior Uveitis
Lead Sponsor:
Alcon Research
Conditions:
Endogenous Anterior Uveitis
Eligibility:
All Genders
2+ years
Phase:
PHASE3
Brief 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 a...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
111 Patients enrolled
Trial Details
Trial ID
NCT01201798
Start Date
October 1 2010
End Date
August 1 2011
Last Update
November 15 2012
Active Locations (1)
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1
Contact Alcon Call Center
Fort Worth, Texas, United States, 76134