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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. 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Recruitment Status : Withdrawn (Study withdrawn without starting or enrolling subjects due to a business decision to not proceed with the project.)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
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Study withdrawn prior to determining study details

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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Official Title: Study Withdrawn Prior to Determining Official Title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

Primary Outcome Measures :
  1. Safety and efficacy of a new allergy medication [ Time Frame: 0 ]

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.

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

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
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Responsible Party: Bausch & Lomb Incorporated Identifier: NCT00375596    
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:
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Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Immune System Diseases
Vasoconstrictor Agents
Dermatologic Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Allergic Agents