Comparing a Monthly Replacement Lens Versus a Daily Disposable Lens

Study Overview
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Brief Summary
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The purpose of this study is to compare subjective ratings of lens handling at insertion for a monthly replacement lens versus a daily disposable lens in habitual soft lens wearers.

Detailed Description
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This is a non-dispensing, randomized, double-masked, crossover study. Participants will wear 2 different contact lenses bilaterally over 4 study visits, all conducted on the same day. Estimated duration of involvement for each participant is 4 hours.

Official Title
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Comparing Clariti Elite Versus Proclear 1 Day

Conditions
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Myopia, Hyperopia

Intervention / Treatment
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* Device: Control Contact Lens
* Device: Test Contact Lens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Are 17 to 40 years of age and have full legal capacity to volunteer; Have read and signed an information consent letter; Are willing and able to follow instructions and maintain the appointment schedule; Are habitual daily wearers of spherical single vision soft contact lenses to correct for distance vision in each eye Are correctable to a visual acuity of 20/20 or better (in each eye) with sphero-cylindrical subjective refraction; Have an astigmatism of ≤ 0.75DC in subjective refraction; Can be fit with the study contact lenses with a power between -1.00 and -6.00DS; this translates to best corrected vision sphere refraction that vertexes to a CL power between -1.00 and -6.00 (inclusive) at screening visit. Demonstrate an acceptable fit with the study lenses. Exclusion Criteria: Have taken part in another clinical research study within the last 14 days; Are currently habitual wearers of toric, multifocal or monovision lenses. Have worn any rigid contact lenses in the past 6 months Are an extended lens wearer (i.e., sleeping with their lenses) Have a difference of ≥1.5 D in best vision sphere subjective refraction between eyes; Have amblyopia and/or distance strabismus/binocular vision problem; Have any known active ocular disease, allergies and/or infection; Have a systemic condition that in the opinion of the investigator may affect a study outcome variable; Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable; Have a known sensitivity to the diagnostic pharmaceuticals to be used in the study; Have undergone refractive error surgery or intraocular surgery; Are a member of CORE directly involved in the study.

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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 |
| --- | --- |
| Experimental: Control Lens, then Test Lens<br>Participants will wear the Control Lens for 90 minutes, then crossover to the Test Lens for 90 minutes. | Device: Control Contact Lens<br>* Daily disposable contact lens for 90 minutes<br>Device: Test Contact Lens<br>* Monthly replacement contact lens for 90 minutes<br>|
| Experimental: Test Lens, then Control Lens<br>Participants will wear the Test Lens for 90 minutes, then crossover to the Control Lens for 90 minutes. | Device: Control Contact Lens<br>* Daily disposable contact lens for 90 minutes<br>Device: Test Contact Lens<br>* Monthly replacement contact lens for 90 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lens Handling at Insertion | Binocular subjective rating of the ease of lens application to eye, using a 0-100 scale (0=Very difficult, 100=Very easy) | 90 minutes of wear | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Refractive Errors, Eye Diseases