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Safety Study of Ophthalmic Solution in Healthy, Normal Volunteers

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.
 
ClinicalTrials.gov Identifier: NCT00223951
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : February 20, 2015
Sponsor:
Information provided by (Responsible Party):
Vistakon Pharmaceuticals

Brief Summary:
The purpose of this study is to evaluate the safety of R89674 0.25% ophthalmic solution in healthy normal volunteers

Condition or disease Intervention/treatment Phase
Healthy Volunteers Eligible for Study; Drug Being Developed for Allergic Conjunctivitis Drug: R89674 (generic name not yet established) Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Multi-Center, Randomized, Double-Masked, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety of R89674 0.25% Ophthalmic Solution in Healthy, Normal Volunteers
Study Start Date : September 2005
Actual Primary Completion Date : December 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pinkeye




Primary Outcome Measures :
  1. Adverse events; biomicroscopy and visual acuity at baseline and Days 7, 21, and 42; ophthalmoscopy and intraocular pressure at baseline and Day 42; physical examination

Secondary Outcome Measures :
  1. No additional endpoints


Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

healthy normal volunteers age >=3 years with normal ocular health and a best-corrected logMAR score of 0.3 or better

-

Exclusion Criteria:

intraocular surgery and/or ocular surgical intervention within last 3 months, refractive surgery within last 6 months, active ocular disorder other than refractive disorders, breastfeeding women, pregnant female < 18 years of age -


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): NCT00223951


Locations
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United States, Arizona
Phoenix, Arizona, United States, 85032
United States, Maryland
Bel Air, Maryland, United States, 21014
United States, Massachusetts
North Andover, Massachusetts, United States, 01845
United States, Nevada
Las Vegas, Nevada, United States, 89102
United States, North Carolina
Charlotte, North Carolina, United States, 28204
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19148
Sponsors and Collaborators
Vistakon Pharmaceuticals
Investigators
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Principal Investigator: Jack V Greiner, OD, DO, PhD Ophthalmic Research Associates, North Andover, MA
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Responsible Party: Vistakon Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00223951    
Other Study ID Numbers: 05-003-10
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: February 20, 2015
Last Verified: February 2015
Keywords provided by Vistakon Pharmaceuticals:
Healthy volunteers, safety, ocular, allergic conjunctivitis, ophthalmic
Additional relevant MeSH terms:
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Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases