ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study Of The Safety And Effectiveness Of A New Treatment For Allergic Conjunctivitis

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: NCT00375596
Recruitment Status : Withdrawn (Study withdrawn without starting or enrolling subjects due to a business decision to not proceed with the project.)
First Posted : September 13, 2006
Last Update Posted : February 20, 2015
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

Brief Summary:
This study will evaluate the safety and efficacy of a new allergy medication

Condition or disease Intervention/treatment Phase
Allergic Conjunctivitis Drug: Ketotifen/vasoconstrictor Phase 2

Detailed Description:
Study withdrawn prior to determining study details

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Parallel Assignment
Official Title: Study Withdrawn Prior to Determining Official Title

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pinkeye
Drug Information available for: Ketotifen
U.S. FDA Resources




Primary Outcome Measures :
  1. Safety and efficacy of a new allergy medication [ Time Frame: 0 ]
    STUDY WITHDRAWN PRIOR TO OUTCOME DETERMINATION



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   6 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be at least 6 years of age, of any race, or either gender.
  • Have a positive allergic history of ocular allergies and a positive skin test reaction to cat hair/dander, ragweed, tree and/or grass pollen within the past 24 months.
  • Have a calculated best-corrected visual acuity of 0.6 logMar or better in each eye as measured using an ETDRS chart.
  • Positive bilateral CAC reaction at Visit 1 & 2.

Exclusion Criteria:

  • Have any known contraindications, allergies, or sensitivities to the use of any of the study medications, or their components.
  • Any ocular condition that, in the opinion of the investigator, could affect the subject's safety or trial parameters
  • Manifest signs or symptoms of clinically active allergic conjunctivitis in either eye at the baseline slit-lamp exam of any visit

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00375596     History of Changes
Other Study ID Numbers: C-02-06-001
First Posted: September 13, 2006    Key Record Dates
Last Update Posted: February 20, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Ketotifen
Vasoconstrictor Agents
Antipruritics
Dermatologic Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Allergic Agents