Toric Contact Lens Performance Study

Study Overview
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Brief Summary
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This study seeks to quantify digital visual performance and subjective visual acceptance of toric contact lenses as compared to spherical lenses in low to moderate astigmatic patients.

Detailed Description
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This is a prospective, single site, randomized, masked, crossover study. This study will evaluate the ability of toric contact lenses to decrease signs and symptoms of asthenopia and improve digital reading performance. Symptoms and objective near vision outcomes will be measured at baseline and after 1 week of wear with each correction.

Official Title
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Toric Contact Lens Performance Study

Conditions
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Astigmatism

Intervention / Treatment
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* Device: Dailies Aqua Comfort Plus Toric
* Device: Dailies Aqua Comfort Plus Sphere


Participation Criteria
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Eligibility Criteria
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Inclusion +6.00 to -6.00 D vertexed sphere power and -0.75 to -1.50 D vertexed refractive cylinder in the right and left eyes Best corrected acuity of 20/25 or better in each eye Self report of at least 4 hrs/day using digital devices Current/established soft contact lens wearer (has worn contact lenses in the past year) Exclusion An optometrist or optometry student History of ocular pathology or surgery Binocular vision disorder (i.e., tropia, convergence or accommodative insufficiency) Gas permeable lens wear for at least 3 months Presbyopic (based on refraction)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 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 |
| --- | --- |
| Experimental: Toric, Then Sphere<br>Participants who received Toric contact lenses first and spherical lenses after 10 days | Device: Dailies Aqua Comfort Plus Toric<br>* Daily disposable soft toric contact lens<br>Device: Dailies Aqua Comfort Plus Sphere<br>* Daily disposable soft spherical contact lens<br>|
| Experimental: Sphere, Then Toric<br>Participants who received Spherical contact lenses first and Toric lenses after 10 days | Device: Dailies Aqua Comfort Plus Toric<br>* Daily disposable soft toric contact lens<br>Device: Dailies Aqua Comfort Plus Sphere<br>* Daily disposable soft spherical contact lens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Near Visual LogMAR Acuity | High contrast LogMAR visual acuity was assessed at 40 cm using the M&S Clinical Trial Suite system (Niles, Illinois, USA). The system was calibrated according to the manufacturer's directions every day, prior to use. Testing was performed binocularly. The test started at 20/200 and continued until three letters were missed on a line. | 10 +/- 2 days |