Mapracorat Ophthalmic Formulation in Subjects With Allergic Conjunctivitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01289431
First received: February 1, 2011
Last updated: November 22, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Conjunctivitis, Allergic
Drug: Mapracorat
Drug: Vehicle
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
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).

Resource links provided by NLM:


Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Ocular Itching [ Time Frame: over all study visits post CAC for up to 2 weeks ] [ Designated as safety issue: No ]
  • Conjunctival redness [ Time Frame: over all study visits post CAC for up to 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Symptoms [ Time Frame: at visit 2 (Day 2), post-dose ] [ Designated as safety issue: No ]
    Allergy symptoms evaluated by subject.

  • Symptoms [ Time Frame: at visit 3, 4, and 5, post-CAC for up to 2 weeks ] [ Designated as safety issue: No ]
    Allergy symptoms evaluated by subject

  • Signs [ Time Frame: at visit 2 (Day 2), post-dose ] [ Designated as safety issue: No ]
    Allergy signs evaluated by investigator

  • Signs [ Time Frame: at visit 3, 4, and 5, post-CAC for up to 2 weeks ] [ Designated as safety issue: No ]
    Allergy signs evaluated by investigator


Enrollment: 251
Study Start Date: February 2011
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mapracorat Drug: Mapracorat
administered daily to each eye for 2 weeks following allergen challenge using a CAC model
Placebo Comparator: Mapracorat Vehicle Drug: Vehicle
administered daily to each eye for 2 weeks following allergen challenge using a CAC model

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01289431

Locations
United States, New York
Bausch & Lomb
Rochester, New York, United States, 14609
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Study Director: Rabia Ozden, OD Bausch & Lomb Incorporated
  More Information

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01289431     History of Changes
Other Study ID Numbers: 685
Study First Received: February 1, 2011
Last Updated: November 22, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on September 16, 2014