Mapracorat Ophthalmic Formulation in Subjects With Allergic Conjunctivitis

NCT01289431 | Completed Phase 2 Results

• 1 other identifier: 685
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Ciliary Redness

  8 hours

• Episcleral Redness

  8 hours

Study Arms (2)

Mapracorat

EXPERIMENTAL

Drug: Mapracorat

Mapracorat Vehicle

PLACEBO COMPARATOR

Drug: Vehicle

Interventions

Mapracorat DRUG

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

Mapracorat

Vehicle DRUG

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

Mapracorat Vehicle

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (1)

Bausch & Lomb

Rochester, New York, 14609, United States

Location

MeSH Terms

Conditions

Conjunctivitis, Allergic

Interventions

R-1,1,1-trifluoro-4-(5-fluoro-2,3-dihydrobenzofuran-7-yl)-4-methyl-2-(((2-methyl-5-quinolyl)amino)methyl)pentan-2-ol

Condition Hierarchy (Ancestors)

Conjunctivitis; Conjunctival Diseases; Eye Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Study Director
• Organization: Bausch Health

susan.harris@bauschhealth.com

Study Officials

• Rabia Ozden, OD

  Bausch & Lomb Incorporated

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2011
• First Posted: February 3, 2011
• Study Start: February 1, 2011
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: September 4, 2020
• Results First Posted: September 4, 2020

Record last verified: 2020-09

Locations

US (1)