Phase 3
N=110
Safety and Efficacy of Difluprednate 0.05% for the Treatment of Anterior Uveitis
Endogenous Anterior Uveitis
Bottom Line
View on ClinicalTrials.gov: NCT01201798 ↗Enrolled (actual)
110
Serious AEs
1.8%
Results posted
Nov 2012
Primary outcome: Primary: Change From Baseline (Day 0) in Anterior Chamber Cell Grade at Day 14 — 2.6; 2.6; -2.2; -2.0 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Difluprednate 0.05% ophthalmic emulsion (Drug); Prednisolone acetate 1.0% ophthalmic suspension (Drug)
- Age
- Pediatric, Adult, Older Adult · 2+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Aug 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline (Day 0) in Anterior Chamber Cell Grade at Day 14 |
2.6; 2.6; -2.2; -2.0 | — |
| SECONDARY Change From Baseline (Day 0) in Anterior Chamber Cell Grade at All Time Points Other Than Day 14 |
2.6; 2.6; -1.1; -1.0; -1.8; -1.6 | — |
| SECONDARY Change From Baseline (Day 0) in Anterior Chamber Flare Grade at All Time Points |
2.2; 2.3; -1.1; -1.2; -1.6; -1.6 | — |
| SECONDARY Proportion of Subjects With Anterior Chamber Cell Grade of 0 |
15.2; 6.4; 34.8; 25.5; 65.2; 55.3 | — |
| SECONDARY Proportion of Subjects With Anterior Chamber Cell Count of 0 |
13.0; 2.1; 21.7; 21.3; 52.2; 38.3 | — |
| SECONDARY Proportion of Subjects With Anterior Chamber Cell Count ≤5 and Flare Grade of 0 |
13.0; 14.9; 41.3; 40.4; 78.3; 61.7 | — |
| SECONDARY Proportion of Subjects With Anterior Chamber Cell Grade ≤1 |
50.0; 57.4; 87.0; 80.9; 93.5; 85.1 | — |
| SECONDARY Proportion of Subjects Who Discontinued Due to Lack of Efficacy |
0; 14.9 | — |
| SECONDARY Change From Baseline (Day 0) in Visual Analog Scale (VAS) Total Symptom Score at All Time Points |
186.7; 203.2; -88.4; -88.4; -108.2; -123.8 | — |
| SECONDARY Change From Baseline (Day 0) in Slit-Lamp Total Sign Score at All Visits |
7.1; 7.3; -3.5; -3.6; -5.2; -5.0 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01201798). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.