N/A
N=32
Objective Testing of Tear Film Stability
Contact Lens Solutions
Bottom Line
View on ClinicalTrials.gov: NCT00789529 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
May 2013
Primary outcome: Primary: Objective, In-vivo Soft Contact Lens Wettability Index — -1.82; -1.98 wettability index
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Opti-Free® RepleniSH® MPDS (Device); ReNu MultiPlus® (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Manhattan Vision Associates
- Primary completion
- Nov 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective, In-vivo Soft Contact Lens Wettability Index |
-1.82; -1.98 | — |
| SECONDARY Subject Questionnaire Response |
42.7; 43.1 | — |
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 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)
Data sourced from ClinicalTrials.gov (NCT00789529). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.