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

February 1, 2011
November 22, 2013
February 2011
April 2011   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01289431 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Mapracorat Ophthalmic Formulation in Subjects With Allergic Conjunctivitis
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).

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Conjunctivitis, Allergic
  • Drug: Mapracorat
    administered daily to each eye for 2 weeks following allergen challenge using a CAC model
  • Drug: Vehicle
    administered daily to each eye for 2 weeks following allergen challenge using a CAC model
  • Experimental: Mapracorat
    Intervention: Drug: Mapracorat
  • Placebo Comparator: Mapracorat Vehicle
    Intervention: Drug: Vehicle
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
251
April 2011
April 2011   (final data collection date for primary outcome measure)

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
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01289431
685
No
Bausch & Lomb Incorporated
Bausch & Lomb Incorporated
Not Provided
Study Director: Rabia Ozden, OD Bausch & Lomb Incorporated
Bausch & Lomb Incorporated
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP