Back to resultsComparison of CL Wear Between Two Allergy Drops
Primary Purpose
Allergic Conjunctivitis
Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
epinastine HCL and olopatadine HCL
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Conjunctivitis
Eligibility Criteria
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
Sites / Locations
Outcomes
Primary Outcome Measures
Contact lens objective and subjective clinical performance testing
Secondary Outcome Measures
Full Information
NCT ID
NCT00489398
First Posted
June 19, 2007
Last Updated
October 5, 2010
Sponsor
Hom, Milton M., OD, FAAO
Collaborators
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00489398
Brief Title
Comparison of CL Wear Between Two Allergy Drops
Official Title
Comparison of CL Wear Between Epinastine Hydrochloride and Olopatadine Hydrochloride
Study Type
Interventional
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Withdrawn
Why Stopped
Protocol changes
Study Start Date
July 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Hom, Milton M., OD, FAAO
Collaborators
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Comparison of two allergy drops for enhancing comfort and performance of contact lens wear
Detailed Description
Contact lens patients will instill allergy drops and subjective and objective tests will be performed
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Conjunctivitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Single
Allocation
Randomized
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
epinastine HCL and olopatadine HCL
Primary Outcome Measure Information:
Title
Contact lens objective and subjective clinical performance testing
Time Frame
up to 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Milton M Hom, OD FAAO
Organizational Affiliation
Private Practice
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Comparison of CL Wear Between Two Allergy Drops
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