Last reviewed · How we verify
A Single-Center, Double-Masked, Randomized, Placebo-Controlled Evaluation of Prednisolone Sodium Phosphate Ophthalmic Solution, 1% Compared to Placebo in a Modified Conjunctival Allergen Challenge (CAC) Model
The purpose of this study is to evaluate the effectiveness of the modified Conjunctival Allergen Challenge (CAC) and observe how the produced allergic inflammation reacts to treatment with a proven ocular anti-inflammatory medication, Prednisolone, assessed by the following measures: Chronic Allergic Inflammation assessed using confocal microscopy Ocular itching Conjunctival redness
Details
| Lead sponsor | ORA, Inc. |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 16 |
| Start date | 2012-11 |
| Completion | 2012-12 |
Conditions
- Chronic Allergic Conjunctivitis
Interventions
- Prednisolone Sodium Phosphate Ophthalmic Solution 1%
- Tears Naturale II Ophthalmic Solution
Primary outcomes
- Inflammation Change From Baseline to Day 6 — 90 minutes post CAC
Ocular inflammation was measured by a masked clinician on a 4-point scale 90 minutes after the conjunctival allergen challenge (CAC) . 0 = best (little to no inflammation), 4 = worst (most inflammation).
Countries
United States