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Mapracorat Ophthalmic Formulation in Subjects With Allergic Conjunctivitis

Primary Purpose

Conjunctivitis, Allergic

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Mapracorat
Vehicle
Sponsored by
Bausch & Lomb Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Conjunctivitis, Allergic

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bausch & Lomb

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Mapracorat

Mapracorat Vehicle

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
February 1, 2011
Last Updated
September 2, 2020
Sponsor
Bausch & Lomb Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT01289431
Brief Title
Mapracorat Ophthalmic Formulation in Subjects With Allergic Conjunctivitis
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).
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Conjunctivitis, Allergic

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
236 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mapracorat
Arm Type
Experimental
Arm Title
Mapracorat Vehicle
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Mapracorat
Intervention Description
administered daily to each eye for 2 weeks following allergen challenge using a CAC model
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
administered daily to each eye for 2 weeks following allergen challenge using a CAC model
Primary Outcome Measure Information:
Title
Ocular Itching
Description
Ocular itching was assessed by the participant on a 0-4 scale with half unit increments allowed. Lower scores indicate less ocular itching.
Time Frame
8 hours
Title
Conjunctival Redness
Description
Conjunctival redness was assessed by the Investigator on a 0-4 scale with half unit increments allowed. Lower scores indicate less conjunctival redness.
Time Frame
8 hours
Secondary Outcome Measure Information:
Title
Ciliary Redness
Description
The Investigator evaluated ciliary redness on a 0-4 scale with half unit increments allowed. A lower score is indicative of less ciliary redness.
Time Frame
8 hours
Title
Episcleral Redness
Description
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.
Time Frame
8 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rabia Ozden, OD
Organizational Affiliation
Bausch & Lomb Incorporated
Official's Role
Study Director
Facility Information:
Facility Name
Bausch & Lomb
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States

12. IPD Sharing Statement

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Mapracorat Ophthalmic Formulation in Subjects With Allergic Conjunctivitis

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