The Impact of Soft Contact Lens Attributes on Symptoms Associated With Digital Eye Strain in Symptomatic Soft Contact Lens Wearers

Study Overview
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Brief Summary
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Despite its prevalence, the ocular causes of eye fatigue or unknown and may be related to the cornea/contact lens surface, the accommodative system, the convergence system, overall postural/muscle fatigue, or a combination of these or other causes. The current study aims to systematically investigate the incremental benefits in ameliorating eye fatigue.

Official Title
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The Impact of Soft Contact Lens Attributes on Symptoms Associated With Digital Eye Strain in Symptomatic Soft Contact Lens Wearers

Conditions
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Asthenopia, Myopia

Intervention / Treatment
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* Device: Contact lens with Multifocal Optics
* Device: Contact lens with Single Vision Optics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Self-reported eye fatigue at least once per week attributable to digital device use with baseline. Uses a digital device (phone, tablet, computer, etc) at least 4 hours per day Mobile digital device with active data and text plan, able to receive email and text messages Habitual 2-week or monthly silicone single vision hydrogel soft contact lens use; habitually wearing lenses for 6 or more hours per day for 5 or more days per week for the past 30 days Habitual soft contact lens prescription optimized over-refraction within ±0.25 D 18-35 years of age The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. Vertex corrected refractive cylinder must be -0.75 or less. Visual acuity best correctable to 20/25 or better for each eye The subject must read and sign the Informed Consent form. Exclusion Criteria: A habitual wearer of any of the test lenses Any active conditions that may prevent soft contact lens wear. Any doctor diagnosed, self-reported ocular surface disease or dry eye requiring regular, ongoing treatment Any doctor diagnosed, self-reported accommodative or binocular vision issues History of issues of eye alignment or binocularity by self-report

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Multifocal Optics first, then Single Vision Optics<br>First Intervention (1 week) Second Intervention (1 week) | Device: Contact lens with Multifocal Optics<br>* This contact lens has optics to aid the accommodative and convergence systems<br>Device: Contact lens with Single Vision Optics<br>* This contact lens has standard single vision optics<br>|
| Other: Single Vision Optics first, then Multifocal Optics<br>First Intervention (1 week) Second Intervention (1 week) | Device: Contact lens with Multifocal Optics<br>* This contact lens has optics to aid the accommodative and convergence systems<br>Device: Contact lens with Single Vision Optics<br>* This contact lens has standard single vision optics<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject Reported Eye Fatigue | Subjective Rating of Eye Fatigue, response to question How would you rate your overall eye fatigue/tiredness? on a 0-100 slider visual analog scale, where 0 represents 'Not Noticeable' and 100 represents 'Very Noticeable', with the numerical representation of their visual analog selection displayed to the right of the slider scale. Score reported is rating as described above. | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Eye Fatigue