Mapracorat Ophthalmic Formulation in Subjects With Allergic Conjunctivitis

Phase 2

Completed

• Conditions: Conjunctivitis, Allergic
• Interventions: Drug: Mapracorat; Drug: Vehicle

• Registration Number: NCT01289431
• Lead Sponsor: Bausch & Lomb Incorporated

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-02-01
• Study First Submitted QC: 2011-02-02
• Study First Posted: 2011-02-03
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Disposition First Submitted: 2012-02-28
• Disposition First Submitted QC: 2012-05-03
• Disposition First Posted: 2012-05-07
• Results First Submitted: 2020-08-18
• Status Verified: 2020-09
• Results First Submitted QC: 2020-09-02
• Last Update Submitted: 2020-09-02
• Results First Posted: 2020-09-04
• Last Update Posted: 2020-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 236

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mapracorat	Mapracorat	-
Mapracorat Vehicle	Vehicle	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Ciliary Redness	8 hours	The Investigator evaluated ciliary redness on a 0-4 scale with half unit increments allowed. A lower score is indicative of less ciliary redness.
Episcleral Redness	8 hours	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.

Trial Locations

Locations (1)

Bausch & Lomb; 🇺🇸 Rochester, New York, United States