Clinical Evaluation of 3 Contact Lens Materials With 3 Solution Types

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Evaluation of 3 Contact Lens Materials With 3 Solution Types

Conditions
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Visual Acuity, Slit Lamp Biomicroscopy (Corneal Staining Assessment)

Intervention / Treatment
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* Device: Opti-Free : RevitaLens / Clear Care : RevitaLens
* Device: Opti-Free : RevitaLens / RevitaLens : Clear Care
* Device: Clear Care : RevitaLens/ Opti-Free : RevitaLens
* Device: Clear Care : RevitaLens / RevitaLens : Opti-Free
* Device: RevitaLens : Clear Care/ Opti-Free : RevitaLens
* Device: RevitaLens : Clear Care / RevitaLens : Opti-Free
* Device: RevitaLens : Opti-Free / Clear Care : RevitaLens
* Device: RevitaLens : Opit-Free / RevitaLens : Clear Care


Participation Criteria
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Eligibility Criteria
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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. Diabetes 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). Any corneal distortion due to previous rigid gas permeable lens wear, surgery or pathology. History of any ocular or corneal surgery (eg, RK, PRK, LASIK). Habitual contact lens wear modality as extended wear. Participation in any pharmaceutical or medical device related clinical trial within 7 days prior to study enrollment. History of binocular vision abnormality or strabismus. Habitual wearers of rigid gas permeable lens within the past 3 months. Employees of investigational clinic (investigator, coordinator, and technician etc.) or family members of employees of the investigational clinic by self-report

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: etafilcon A<br>Eligible subjects were randomized to the etafilcon A lens in both eyes throughout the entire duration of the study. | Device: Opti-Free : RevitaLens / Clear Care : RevitaLens<br>* Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.<br>* Other names: Right eye : left eye / right eye : left eye;Device: Opti-Free : RevitaLens / RevitaLens : Clear Care<br>* Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.<br>* Other names: Right eye : left eye / right eye : left eye;Device: Clear Care : RevitaLens/ Opti-Free : RevitaLens<br>* Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.<br>* Other names: Right eye : left eye / right eye : left eye;Device: Clear Care : RevitaLens / RevitaLens : Opti-Free<br>* Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.<br>* Other names: Right eye : left eye / right eye : left eye;Device: RevitaLens : Clear Care/ Opti-Free : RevitaLens<br>* Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.<br>* Other names: Right eye : left eye / right eye : left eye;Device: RevitaLens : Clear Care / RevitaLens : Opti-Free<br>* Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.<br>* Other names: Right eye : left eye / right eye : left eye;Device: RevitaLens : Opti-Free / Clear Care : RevitaLens<br>* Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.<br>* Other names: Right eye : left eye / right eye : left eye;Device: RevitaLens : Opit-Free / RevitaLens : Clear Care<br>* Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.<br>* Other names: Right eye : left eye / right eye : left eye;|
| Active Comparator: senofilcon A<br>Eligible subjects were randomized to the senofilcon A lens in both eyes throughout the entire duration of the study. | Device: Opti-Free : RevitaLens / Clear Care : RevitaLens<br>* Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.<br>* Other names: Right eye : left eye / right eye : left eye;Device: Opti-Free : RevitaLens / RevitaLens : Clear Care<br>* Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.<br>* Other names: Right eye : left eye / right eye : left eye;Device: Clear Care : RevitaLens/ Opti-Free : RevitaLens<br>* Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.<br>* Other names: Right eye : left eye / right eye : left eye;Device: Clear Care : RevitaLens / RevitaLens : Opti-Free<br>* Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.<br>* Other names: Right eye : left eye / right eye : left eye;Device: RevitaLens : Clear Care/ Opti-Free : RevitaLens<br>* Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.<br>* Other names: Right eye : left eye / right eye : left eye;Device: RevitaLens : Clear Care / RevitaLens : Opti-Free<br>* Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.<br>* Other names: Right eye : left eye / right eye : left eye;Device: RevitaLens : Opti-Free / Clear Care : RevitaLens<br>* Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.<br>* Other names: Right eye : left eye / right eye : left eye;Device: RevitaLens : Opit-Free / RevitaLens : Clear Care<br>* Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.<br>* Other names: Right eye : left eye / right eye : left eye;|
| Active Comparator: senofilcon C<br>Eligible subjects were randomized to the senofilcon C lens in both eyes throughout the entire duration of the study. | Device: Opti-Free : RevitaLens / Clear Care : RevitaLens<br>* Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.<br>* Other names: Right eye : left eye / right eye : left eye;Device: Opti-Free : RevitaLens / RevitaLens : Clear Care<br>* Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.<br>* Other names: Right eye : left eye / right eye : left eye;Device: Clear Care : RevitaLens/ Opti-Free : RevitaLens<br>* Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.<br>* Other names: Right eye : left eye / right eye : left eye;Device: Clear Care : RevitaLens / RevitaLens : Opti-Free<br>* Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.<br>* Other names: Right eye : left eye / right eye : left eye;Device: RevitaLens : Clear Care/ Opti-Free : RevitaLens<br>* Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.<br>* Other names: Right eye : left eye / right eye : left eye;Device: RevitaLens : Clear Care / RevitaLens : Opti-Free<br>* Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.<br>* Other names: Right eye : left eye / right eye : left eye;Device: RevitaLens : Opti-Free / Clear Care : RevitaLens<br>* Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.<br>* Other names: Right eye : left eye / right eye : left eye;Device: RevitaLens : Opit-Free / RevitaLens : Clear Care<br>* Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.<br>* Other names: Right eye : left eye / right eye : left eye;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject Comfort | 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. | Up to 2-Hours Post Lens Fitting |