Mapracorat Ophthalmic Formulation in Subjects With Allergic Conjunctivitis

NCT ID: NCT01289431

Last Updated: 2020-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 236 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2011-04-30

Brief Summary

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.

Conditions

Conjunctivitis, Allergic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Mapracorat

Group Type: EXPERIMENTAL

Mapracorat

Intervention Type: DRUG

administered daily to each eye for 2 weeks following allergen challenge using a CAC model

Mapracorat Vehicle

Group Type: PLACEBO_COMPARATOR

Vehicle

Intervention Type: DRUG

administered daily to each eye for 2 weeks following allergen challenge using a CAC model

Interventions

Mapracorat

administered daily to each eye for 2 weeks following allergen challenge using a CAC model

Intervention Type: DRUG

Vehicle

administered daily to each eye for 2 weeks following allergen challenge using a CAC model

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rabia Ozden, OD

Role: STUDY_DIRECTOR

Bausch & Lomb Incorporated

Locations

Bausch & Lomb

Rochester, New York, United States

Countries

United States

Other Identifiers

685

Identifier Type: -

Identifier Source: org_study_id