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Evaluation of Efficacy of Ophthalmic Solution in Seasonal Allergic Conjunctivitis

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: August 15, 2006
Last Update Posted: September 27, 2011
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.
Information provided by (Responsible Party):
Vistakon Pharmaceuticals
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 Intervention Phase
Allergic Conjunctivitis Drug: R89674 0.025% ophthalmic solution Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Vistakon Pharmaceuticals:

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

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

Enrollment: 365
Study Start Date: August 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)

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

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
  Contacts and Locations
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

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
Study Director: Reza Haque, MD Vistakon Pharmaceuticals
  More Information

Responsible Party: Vistakon Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00364091     History of Changes
Other Study ID Numbers: 06-003-09
First Submitted: August 11, 2006
First Posted: August 15, 2006
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, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Immune System Diseases
Pharmaceutical Solutions
Ophthalmic Solutions