1 Week Crossover Dispensing Study Between Two Soft Contact Lenses

Study Overview
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Brief Summary
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The objective of this investigation is to compare the visual clinical performance of a silicone hydrogel daily disposable investigational contact lenses to a hydrogel daily disposable commercially available contact lenses.

Detailed Description
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This is a prospective, bilateral, double masked (participant and investigator), randomized, cross-over dispensing study with 1 week wearing period in each arm by comparing visual acuity and subjective vision quality.

Official Title
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1 Week Crossover Dispensing Study: Buttermere Versus MiSight 1 Day Soft Contact Lenses

Conditions
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Myopia

Intervention / Treatment
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* Device: Test Lenses
* Device: Control Lenses


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Are 8 to 18 years of age inclusive and have full legal capacity to volunteer; Have read and signed and dated the Parental Permission Form (for those aged 16 and younger); participant has read, signed and dated the study Information Consent Letter (if aged 17 or 18 years) or Assent (aged 16 and younger); 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; Currently wears spherical soft contact lenses or myopia control soft lenses; Have a pair of wearable back-up spectacles; Are willing and able to wear contact lenses for at least 10 hours a day, 6 days a week while in the study; Are myopic with subjective refraction: -0.75D to -7.00D spherical, with an astigmatism ≤ -0.75D in each eye with maximum spherical equivalent anisometropia of 1.00D Are correctable to a visual acuity of +0.10 logMAR or better (in each eye) with sphero-cylindrical subjective refraction; Have clear corneas with no corneal scars or any active ocular disease; Can be fit with the study contact lenses with a power between -0.75 and -7.00 DS; this translates to best corrected vision sphere refraction that vertexes to a CL power between -0.75 and -7.00 (inclusive) at screening visit. Demonstrate an acceptable fit with the study lenses. Demonstrate that they can safely and independently insert and remove contact lenses at the screening/fitting visit; Exclusion Criteria: Have taken part in another clinical research study within the last 14 days; Are currently habitual wearers of toric lenses. Have worn any rigid contact lenses or ortho-keratology lenses in the past 30 days Are an extended lens wearer (i.e., sleeping with their lenses) Are on ongoing atropine treatment for myopia control Have a difference of > 1.0 D in best vision sphere subjective refraction between eyes; Have amblyopia and/or 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: 8 Years
Maximum Age: 18 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: Test Lenses, Then Control Lenses<br>Participants will wear the Test Lenses in both eyes for one week and then cross over to the Control Lenses in both eyes for one week. | Device: Test Lenses<br>* Daily disposable, silicone hydrogel investigational lenses for one week<br>Device: Control Lenses<br>* Daily disposable, hydrogel commercially available lenses for one week<br>|
| Experimental: Control Lenses, Then Test Lenses<br>Participants will wear the Control Lenses in both eyes for one week and then cross over to the Test Lenses in both eyes for one week. | Device: Test Lenses<br>* Daily disposable, silicone hydrogel investigational lenses for one week<br>Device: Control Lenses<br>* Daily disposable, hydrogel commercially available lenses for one week<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| High contrast, binocular, distance visual acuity | Distance visual acuity (LogMAR) will be measured using high and low contrast computer-generated acuity charts. | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Vision Quality | Subjective vision quality on 0-100 scale, integer steps (0 = Very poor; 100 = Excellent vision, totally sharp) | 7 days |