Mapracorat Ophthalmic Formulation in Subjects With Allergic Conjunctivitis

Study Overview
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Brief Summary
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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.

Official Title
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Dose Ranging Study to Evaluate the Safety and Efficacy of Mapracorat Ophthalmic Formulation, in Subjects With Allergic Conjunctivitis Compared to Vehicle in a Conjunctival Allergen Challenge (CAC).

Conditions
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Conjunctivitis, Allergic

Intervention / Treatment
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* Drug: Mapracorat
* Drug: Vehicle


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mapracorat<br> | Drug: Mapracorat<br>* administered daily to each eye for 2 weeks following allergen challenge using a CAC model<br>|
| Placebo Comparator: Mapracorat Vehicle<br> | Drug: Vehicle<br>* administered daily to each eye for 2 weeks following allergen challenge using a CAC model<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Itching | Ocular itching was assessed by the participant on a 0-4 scale with half unit increments allowed. Lower scores indicate less ocular itching. | 8 hours | 
| Conjunctival Redness | Conjunctival redness was assessed by the Investigator on a 0-4 scale with half unit increments allowed. Lower scores indicate less conjunctival redness. | 8 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ciliary Redness | The Investigator evaluated ciliary redness on a 0-4 scale with half unit increments allowed. A lower score is indicative of less ciliary redness. | 8 hours | 
| Episcleral Redness | Episcleral redness was evaluated by the Investigator using a 0-4 scale with half unit increments allowed. A lower score is indicative of less episcleral redness. | 8 hours |