Overview

Study Evaluating the Efficacy of Administration of Cyclosporine (Low Dose and High Dose) and Prednisolone Acetate Compared to Its Components and Vehicle in Patients With Allergic Conjunctivitis

Status:
Completed
Trial end date:
2010-08-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine the efficacy and safety of the administration of cyclosporine and prednisolone acetate compared to placebo in the treatment of allergic conjunctivitis.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Fovea Pharmaceuticals SA
Treatments:
Cyclosporine
Cyclosporins
Methylprednisolone
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Pharmaceutical Solutions
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Criteria
Inclusion Criteria:

- history of ocular allergies and a positive skin test reaction to perennial allergens
within the past 24 months and a history of chronic eye irritation

- visual acuity score ≥ 0.60 (EDTS)

- negative urine pregnancy test for female patients, and use of adequate birth control
throughout the study period.

Exclusion Criteria:

- active ocular infection; preauricular lymphadenopathy or ocular condition that could
affect study; glaucoma or abnormal intraocular pressure; ocular surgery within past 3
months; history of asthma, pregnancy or nursing

- contraindications or known allergies to the study drug(s)