Mapracorat Ophthalmic Formulation in Subjects With Allergic Conjunctivitis

Bausch + Lomb

Status and phase

Completed

Phase 2

Conditions

Conjunctivitis, Allergic

Treatments

Drug: Vehicle

Drug: Mapracorat

Study type

Interventional

Funder types

Industry

Identifiers

NCT01289431

685

Details and patient eligibility

About

The objective of this study is to evaluate the dose response, and efficacy of Mapracorat ophthalmic formulation compared to its vehicle for the prevention of symptoms and signs associated with allergic conjunctivitis using a conjunctival allergen challenge (CAC) model.

Enrollment

236 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

positive history of ocular allergies and a positive skin test reaction
positive bilateral CAC reaction

Exclusion criteria

have known contraindications or sensitivities to the use of any of the study medications(s) or their components.
have any ocular condition or significant illness that, in the opinion of the investigator, could affect the subject's safety or trial parameters.
had ocular surgical intervention within three (3) months prior to Visit 1 or during the study and/or a history of refractive surgery within the past 3 months;
a known history of retinal detachment, diabetic retinopathy, or active retinal disease;
the presence of an active ocular infection or positive history of an ocular herpetic infection at any visit.
use of any disallowed medications during the period indicated prior to Visit 1 and during the study.
have planned surgery during the trial period or within 30 days after.
have an intraocular pressure that is less than 5 mmHg or greater than 22 mmHg or any type of glaucoma at Visit 1