- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00244543
Evaluation of Efficacy of Ophthalmic Solution in Induced Allergic Conjunctivitis
A Single-Center, Double-Masked, Randomized, Placebo-Controlled, Evaluation of the Onset and Duration of Action of R89674 0.25% Ophthalmic Solution in Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment
Phase
- Phase 3
Contacts and Locations
Study Locations
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Massachusetts
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North Andover, Massachusetts, United States
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
history of ocular allergies and a positive skin test reaction to cat hair, cat dander, grasses, ragweed, and/or trees within the past 24 months; calculated best-corrected visual acuity of 0.6 logMar or better in each eye; positive bilateral conjunctival allergy challenge reaction
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Exclusion Criteria:
narrow angle glaucoma, clinically significant blepharitis, follicular conjunctivitis, iritis, pterygium or diagnosis of dry eye; ocular surgical intervention within 3 months; history of refractive surgery within 6 months; known history of retinal detachment, diabetic retinopathy, or progressive retinal disease; presence of active ocular infection positive history of an ocular herpetic infection; preauricular lymphadenopath; manifest signs or symptoms of clinically active allergic conjunctivitis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Ocular itching and conjunctival redness post challenge
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Secondary Outcome Measures
Outcome Measure |
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Ciliary and episcieral redness; chemosis; lid swelling; tearing; ocular mucous discharge; and nasal symptoms. All measured postchallenge
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Ingerman Avner, MD, Johnson & Johnson
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 05-003-13
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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ORA, Inc.CompletedChronic Allergic ConjunctivitisUnited States
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Clinical Trials on R89674 (generic name not yet established)
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Vistakon PharmaceuticalsCompletedAllergic ConjunctivitisUnited States
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Vistakon PharmaceuticalsCompletedHealthy Volunteers Eligible for Study; Drug Being Developed for Allergic ConjunctivitisUnited States
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CrystalGenomics, Inc.UnknownSolid TumourKorea, Republic of
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Vistakon PharmaceuticalsCompletedAllergic ConjunctivitisUnited States
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University College, LondonPublic Health EnglandCompletedTuberculosisUnited Kingdom
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Vistakon PharmaceuticalsCompletedAllergic ConjunctivitisUnited States
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Danone Asia Pacific Holdings Pte, Ltd.Completed
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Bluebird International ClinicNot yet recruiting
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Huazhong University of Science and TechnologyUnknownGeneral Anesthetic Drug Adverse Reaction | Coronary Artery Bypass Graft RedoChina
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Medical University of ViennaCompletedSepsis | Healthy VolunteersAustria