Objective Testing of Tear Film Stability

Manhattan Vision Associates

Status: Completed

Conditions: Contact Lens Solutions

Treatments: Device: ReNu MultiPlus®; Device: Opti-Free® RepleniSH® MPDS

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00789529

CS-101

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

1

Active Comparator group

Description:

Opti-Free® RepleniSH® MPDS

Treatment:

Device: Opti-Free® RepleniSH® MPDS

2

Active Comparator group

Description:

Renu MultiPlus®

Treatment:

Device: ReNu MultiPlus®