- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00489398
Comparison of CL Wear Between Two Allergy Drops
October 5, 2010 updated by: Hom, Milton M., OD, FAAO
Comparison of CL Wear Between Epinastine Hydrochloride and Olopatadine Hydrochloride
Comparison of two allergy drops for enhancing comfort and performance of contact lens wear
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Detailed Description
Contact lens patients will instill allergy drops and subjective and objective tests will be performed
Study Type
Interventional
Enrollment (Anticipated)
25
Phase
- Phase 4
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Males or females > 18 years old
- Mild to moderate dry eye symptoms
- Likely to complete all study visits and able to provide informed consent
Exclusion Criteria:
- Current use of topical cyclosporine
- Known contraindications to any study medication or ingredients
- Active ocular diseases or uncontrolled systemic disease (blepharitis patients that are actively being treated or disease that is uncontrollable)
- Ocular surgery within the past 3 months
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
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Contact lens objective and subjective clinical performance testing
Time Frame: up to 3 months
|
up to 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Milton M Hom, OD FAAO, Private Practice
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 Major Dates
Study Start
July 1, 2007
Study Completion (Anticipated)
December 1, 2008
Study Registration Dates
First Submitted
June 19, 2007
First Submitted That Met QC Criteria
June 20, 2007
First Posted (Estimate)
June 21, 2007
Study Record Updates
Last Update Posted (Estimate)
October 7, 2010
Last Update Submitted That Met QC Criteria
October 5, 2010
Last Verified
October 1, 2010
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
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Anti-Allergic Agents
- Histamine H1 Antagonists
- Histamine Antagonists
- Histamine Agents
- Histamine H1 Antagonists, Non-Sedating
- Olopatadine Hydrochloride
- Epinastine
Other Study ID Numbers
- 5316
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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