Mapracorat Ophthalmic Formulation in Subjects With Allergic Conjunctivitis

Conjunctivitis, Allergic Clinical Trial

Official title:

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01289431
• Other study ID #: 685
• Status: Completed
• Phase: Phase 2
• Start date: February 2011
• Est. completion date: April 2011

Study information

• Verified date: September 2020
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 236
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Conjunctivitis
• Conjunctivitis, Allergic

Intervention

Drug:
• Mapracorat
administered daily to each eye for 2 weeks following allergen challenge using a CAC model
• Vehicle
administered daily to each eye for 2 weeks following allergen challenge using a CAC model

Locations

Country	Name	City	State
United States	Bausch & Lomb	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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