Evaluation of Efficacy of Ophthalmic Solution in Seasonal Allergic Conjunctivitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vistakon Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00364091
First received: August 11, 2006
Last updated: September 26, 2011
Last verified: September 2011
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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)
  Eligibility

Ages Eligible for Study:   10 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Vistakon Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00364091     History of Changes
Other Study ID Numbers: 06-003-09
Study First Received: August 11, 2006
Last Updated: September 26, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 28, 2014