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Mapracorat Ophthalmic Formulation in Subjects With Allergic Conjunctivitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01289431
First Posted: February 3, 2011
Last Update Posted: December 17, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]
  • Conjunctival redness [ Time Frame: over all study visits post CAC for up to 2 weeks ]

Secondary Outcome Measures:
  • Symptoms [ Time Frame: at visit 2 (Day 2), post-dose ]
    Allergy symptoms evaluated by subject.

  • Symptoms [ Time Frame: at visit 3, 4, and 5, post-CAC for up to 2 weeks ]
    Allergy symptoms evaluated by subject

  • Signs [ Time Frame: at visit 2 (Day 2), post-dose ]
    Allergy signs evaluated by investigator

  • Signs [ Time Frame: at visit 3, 4, and 5, post-CAC for up to 2 weeks ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01289431     History of Changes
Other Study ID Numbers: 685
First Submitted: February 1, 2011
First Posted: February 3, 2011
Last Update Posted: December 17, 2013
Last Verified: November 2013

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