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Evaluation of Efficacy of Ophthalmic Solution in Seasonal Allergic Conjunctivitis

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ClinicalTrials.gov Identifier: NCT00364091
Recruitment Status : Completed
First Posted : August 15, 2006
Last Update Posted : September 27, 2011
Sponsor:
Information provided by (Responsible Party):
Vistakon Pharmaceuticals

Brief Summary:
The purpose of this summary is to evaluate the efficacy and safety of R89674 0.025% ophthalmic solution compared with placebo or an active control in subjects with seasonal allergic conjunctivitis

Condition or disease Intervention/treatment Phase
Allergic Conjunctivitis Drug: R89674 0.025% ophthalmic solution Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 365 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Multi-Center, Randomized, Double-Masked Parallel Group Study Evaluating the Efficacy, Safety, and QOL of R89674 0.25% Ophthalmic Solution Compared to Vehicle or an Active Control in a Modified Model of Environmental Seasonal Allergic Conjunctivitis
Study Start Date : August 2006
Primary Completion Date : October 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care Pinkeye
U.S. FDA Resources




Primary Outcome Measures :
  1. Ocular itching and redness scores at defined timepoints

Secondary Outcome Measures :
  1. QOL, severity of chemosis & redness, ocular itching and redness scores at defined timepoints


Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • history of positive diagnostic test for ragweed within the past 2 years;
  • positive bilateral response to ragweed as induced by conjunctival allergen challenge

Exclusion Criteria:

  • ocular infection;
  • history of retinal detachment, diabetic neuropathy, or any progressive retinal disease;
  • moderate to severe asthma;
  • dry eye syndrome;
  • history of severe, unstable, or uncontrolled cardiovascular, pulmonary, hepatic, renal or autoimmune disease;
  • pregnancy or lactation

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): NCT00364091


Locations
United States, Kentucky
Louisville, Kentucky, United States
United States, Massachusetts
North Andover, Massachusetts, United States
United States, Missouri
Creve Coeur, Missouri, United States
United States, North Carolina
Charlotte, North Carolina, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
United States, Tennessee
Memphis, Tennessee, United States
Sponsors and Collaborators
Vistakon Pharmaceuticals
Investigators
Study Director: Reza Haque, MD Vistakon Pharmaceuticals

Responsible Party: Vistakon Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00364091     History of Changes
Other Study ID Numbers: 06-003-09
First Posted: August 15, 2006    Key Record Dates
Last Update Posted: September 27, 2011
Last Verified: September 2011

Keywords provided by Vistakon Pharmaceuticals:
allergic conjunctivitis, ophthalmology, multicenter, controlled

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