- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00789529
Objective Testing of Tear Film Stability
April 22, 2013 updated by: Manhattan Vision Associates
The purpose of this study is to evaluate the in-vivo wettability of soft contact lenses when cared with two different multi-purpose solutions over a two week wearing period.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York City, New York, United States, 10022
- MVA/IVR
-
-
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 to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- The subject must be at least 18 years of age and no more than 80 years of age.
- The subject must have a best corrected visual acuity of 20/30 or better for each eye.
- The subject must habitually wear contact lenses.
- The subject must have had an eye exam within the last 12 months. The exam data must be available to the investigators prior to the first visit.
- The subject must have normal eyes, no use of ocular medications, no ocular infection of any type, and no ocular inflammation.
- The subject must read understand and sign the Statement of Informed Consent.
- The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
Exclusion Criteria:
- Ocular or systemic allergies or disease that might interfere with contact lens wear.
- Systemic disease, autoimmune disease or use of medication which might interfere with contact lens wear.
- Clinically significant (FDA Scale grade 3 or 4) corneal edema, corneal vascularization, corneal staining or any other abnormalities of the cornea which would contraindicate contact lens wear.
- Clinically significant (FDA Scale grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
- Any ocular infection.
- Pregnancy or lactation.
- Diabetes
- Infectious diseases (e.g. hepatitis, tuberculosis)
- Contagious immunosuppressive diseases (e.g. HIV)
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: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
Opti-Free® RepleniSH® MPDS
|
soft contact lens disinfecting solution
|
Active Comparator: 2
Renu MultiPlus®
|
soft contact lens disinfecting solution
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective, In-vivo Soft Contact Lens Wettability Index
Time Frame: 2 weeks
|
The wettability index is derived from the slope of a metric developed to measure the regularity of the Shack-Hartmann wavefront sensor image.
The more wettable a lens is the more stable the metric and the slope of the metric (the wettability index) is closer to zero.
The more negative values indicate a less wettable the lens.
|
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subject Questionnaire Response
Time Frame: 2 weeks
|
Subject questionnaire response: Overall comfort at 2 weeks in a 0-50 point scale. 0=Very poor 50 = Excellent |
2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: George Zikos, OS, MS, MVA/IVR
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
September 1, 2008
Primary Completion (Actual)
November 1, 2008
Study Completion (Actual)
November 1, 2008
Study Registration Dates
First Submitted
November 11, 2008
First Submitted That Met QC Criteria
November 12, 2008
First Posted (Estimate)
November 13, 2008
Study Record Updates
Last Update Posted (Estimate)
May 31, 2013
Last Update Submitted That Met QC Criteria
April 22, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- CS-101
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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