Objective Testing of Tear Film Stability
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ClinicalTrials.gov Identifier: NCT00789529 |
Recruitment Status :
Completed
First Posted : November 13, 2008
Results First Posted : May 31, 2013
Last Update Posted : May 31, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Contact Lens Solutions | Device: Opti-Free® RepleniSH® MPDS Device: ReNu MultiPlus® | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 32 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | Objective Testing of Tear Film Stability |
Study Start Date : | September 2008 |
Actual Primary Completion Date : | November 2008 |
Actual Study Completion Date : | November 2008 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 1
Opti-Free® RepleniSH® MPDS
|
Device: Opti-Free® RepleniSH® MPDS
soft contact lens disinfecting solution |
Active Comparator: 2
Renu MultiPlus®
|
Device: ReNu MultiPlus®
soft contact lens disinfecting solution |
- 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.
- 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

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00789529
United States, New York | |
MVA/IVR | |
New York City, New York, United States, 10022 |
Principal Investigator: | George Zikos, OS, MS | MVA/IVR |
Responsible Party: | Manhattan Vision Associates |
ClinicalTrials.gov Identifier: | NCT00789529 |
Other Study ID Numbers: |
CS-101 |
First Posted: | November 13, 2008 Key Record Dates |
Results First Posted: | May 31, 2013 |
Last Update Posted: | May 31, 2013 |
Last Verified: | April 2013 |
Contact lenses, wettability, Contact Lens Disinfectant Solutions, pre-lens tear film |