Status:
COMPLETED
Objective Testing of Tear Film Stability
Lead Sponsor:
Manhattan Vision Associates
Collaborating Sponsors:
Alcon Research
Conditions:
Contact Lens Solutions
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00789529
Start Date
September 1 2008
End Date
November 1 2008
Last Update
May 31 2013
Active Locations (1)
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1
MVA/IVR
New York, New York, United States, 10022