Objective Testing of Tear Film Stability

Not Applicable

Completed

• Conditions: Contact Lens Solutions
• Interventions: Device: ReNu MultiPlus®; Device: Opti-Free® RepleniSH® MPDS

• Registration Number: NCT00789529
• Lead Sponsor: Manhattan Vision Associates

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Study First Submitted: 2008-11-11
• Study First Submitted QC: 2008-11-12
• Study First Posted: 2008-11-13
• Results First Submitted: 2011-07-25
• Status Verified: 2013-04
• Results First Submitted QC: 2013-04-22
• Last Update Submitted: 2013-04-22
• Results First Posted: 2013-05-31
• Last Update Posted: 2013-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

1. The subject must be at least 18 years of age and no more than 80 years of age.
2. The subject must have a best corrected visual acuity of 20/30 or better for each eye.
3. The subject must habitually wear contact lenses.
4. 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.
5. The subject must have normal eyes, no use of ocular medications, no ocular infection of any type, and no ocular inflammation.
6. The subject must read understand and sign the Statement of Informed Consent.
7. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.

Exclusion Criteria

1. Ocular or systemic allergies or disease that might interfere with contact lens wear.
2. Systemic disease, autoimmune disease or use of medication which might interfere with contact lens wear.
3. 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.
4. Clinically significant (FDA Scale grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
5. Any ocular infection.
6. Pregnancy or lactation.
7. Diabetes
8. Infectious diseases (e.g. hepatitis, tuberculosis)
9. Contagious immunosuppressive diseases (e.g. HIV)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	ReNu MultiPlus®	Renu MultiPlus®
1	Opti-Free® RepleniSH® MPDS	Opti-Free® RepleniSH® MPDS

Primary Outcome Measures

Name	Time	Method
Objective, In-vivo Soft Contact Lens Wettability Index	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.

Secondary Outcome Measures

Name	Time	Method
Subject Questionnaire Response	2 weeks	Subject questionnaire response: Overall comfort at 2 weeks in a 0-50 point scale.; 0=Very poor 50 = Excellent

Trial Locations

Locations (1)

MVA/IVR; 🇺🇸 New York City, New York, United States