Clinical Evaluation of 3 Contact Lens Materials With 3 Solution Types

Johnson & Johnson Vision Care, Inc.5 sites in 1 country130 target enrollmentFebruary 7, 2018

ConditionsVisual Acuity, Slit Lamp Biomicroscopy (Corneal Staining Assessment)

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Visual Acuity, Slit Lamp Biomicroscopy (Corneal Staining Assessment)
Sponsor: Johnson & Johnson Vision Care, Inc.
Enrollment: 130
Locations: 5
Primary Endpoint: Subject Comfort
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a multi-site, randomized, double-masked, contralateral, 2 treatment x 2 period crossover, dispensing, five-visit study to gain clinical insights of the study lenses and solutions.

Registry

clinicaltrials.gov

Start Date

February 7, 2018

End Date

June 19, 2018

Last Updated

6 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Johnson & Johnson Vision Care, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Potential subjects must satisfy all of the following criteria to be enrolled in the study:
•Subjects must be 18-69 years of age (inclusive).
•Subjects must be habitual disposable hydrogel or silicone hydrogel (1-day, 2-week, or monthly replacement schedule) soft lens wearer in both eyes. Habitual is defined as at least one (1) month of contact lens wear where the lenses are worn for a minimum of six (6) hours per day and a minimum of five (5) days per week.
•Subjects must have best corrected visual acuity of 20/25 (Snellen or equivalent) or better in each eye.
•The subject's refractive sphere (vertexed) must be between -1.00 and -6.00 D in each eye.
•The subject's refractive cylinder must be less than or equal to -1.00 D in each eye.
•The subject must have normal eyes (i.e., no ocular medications or infections of any type).
•Subjects must possess a functional/usable pair of spectacles and bring them to the visit (only if applicable - to the investigators discretion).
•Subjects must read, understand, and sign the Statement of Informed Consent.
•Subjects must appear able and willing to adhere to the instructions set forth in this clinical protocol.

Exclusion Criteria

•Potential subjects who meet any of the following criteria will be excluded from participating in the study:
•Currently pregnant or breast-feeding.
•Any ocular or systemic allergies or disease which may interfere with contact lens wear (at the discretion of the investigator).
•Any systemic disease, autoimmune disease, or use of medication which may interfere with contact lens wear (at the discretion of the investigator).
•Any infectious diseases (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (eg, HIV), by self-report.
•Current habitual use of Restasis, Xiidra, ocular steroids, or any medication (RX or OTC) that may interfere with contact lens wear (at the discretion of the investigator).
•Grade 2 or greater corneal staining or conjunctival injection on the FDA scale.
•Clinically significant (Grade 3 or greater on the FDA scale) corneal edema, corneal vascularization, or any other abnormalities of the cornea (excluding corneal staining) which would contraindicate contact lens wear.
•Clinically significant (Grade 3 or greater on the FDA scale) tarsal abnormalities which might interfere with contact lens wear.
•Any active ocular abnormalities/conditions that may interfere with contact lens wear (at the discretion of the investigator).

Outcomes

Primary Outcomes

Subject Comfort

Time Frame: Up to 2-Hours Post Lens Fitting

Subjective assessment of initial comfort was conducted using Visual Analogue Scale (VAS) of comfort. VAS of comfort consists of a vertical line which represents continuous scale from 0 (extremely uncomfortable) to 100 (extremely comfortable). VAS comfort was measured at 1-min, 5-min, 45-min, and 2-hours post-fit. The average comfort score for each solution was reported. This is a contralateral crossover, subject used the revitalens solution in one eye throughout the entire study therefore there are twice as many observations for revitalens compared to the other solutions.