- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00375596
A Study Of The Safety And Effectiveness Of A New Treatment For Allergic Conjunctivitis
February 19, 2015 updated by: Bausch & Lomb Incorporated
Study Withdrawn Prior to Determining Official Title
This study will evaluate the safety and efficacy of a new allergy medication
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Detailed Description
Study withdrawn prior to determining study details
Study Type
Interventional
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Interventional Model: Parallel Assignment
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
---|---|
Safety and efficacy of a new allergy medication
|
STUDY WITHDRAWN PRIOR TO OUTCOME DETERMINATION
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
September 12, 2006
First Submitted That Met QC Criteria
September 12, 2006
First Posted (Estimate)
September 13, 2006
Study Record Updates
Last Update Posted (Estimate)
February 20, 2015
Last Update Submitted That Met QC Criteria
February 19, 2015
Last Verified
February 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Hypersensitivity, Immediate
- Eye Diseases
- Hypersensitivity
- Conjunctival Diseases
- Conjunctivitis
- Conjunctivitis, Allergic
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Dermatologic Agents
- Anti-Allergic Agents
- Histamine H1 Antagonists
- Histamine Antagonists
- Histamine Agents
- Antipruritics
- Vasoconstrictor Agents
- Ketotifen
Other Study ID Numbers
- C-02-06-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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