Toric Contact Lens Digital Performance and Comfort 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 study seeks to quantify the near visual performance and subjective visual acceptance of toric contact lenses as compared to spherical lenses in an astigmatic cohort of patients. Primary Hypotheses: Subjects will have better near visual acuity and near visual performance with toric, as opposed to spherical, contact lens correction. As such, the following hypotheses will be tested: H01: There is no statistically significant difference in near visual acuity or near vision performance between contact lenses corrections Ha1: There is a statistically significant difference in visual acuity or vision performance between contact lenses corrections

Official Title
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Toric Contact Lens Digital Performance and Comfort Study

Conditions
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Astigmatism

Intervention / Treatment
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* Device: Precision1 for Astigmatism
* Device: Precision1 Sphere


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 to 39 years of age (inclusive) pl to -6.00D vertexed sphere power and -0.75 to -1.50D vertexed refractive cylinder OD and OS Current/established full time (>6 days week, >8 hours/day) soft contact lens wearer Best corrected acuity of 20/25 or better in each eye Self-report of at least 4 hrs/day using digital devices Willing to wear lenses at least 8 hours each day during the study period Able to speak and read English at a high school level / have at least a high school diploma or equivalent (by self-report) Enclusion Criteria: 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 Symptomatic soft contact lens wearer (CLDEQ-8 score <12 at baseline)

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: Precision1 for Astigmatism<br>* Daily disposable soft toric contact lens<br>Device: Precision1 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: Precision1 for Astigmatism<br>* Daily disposable soft toric contact lens<br>Device: Precision1 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 10+/-2 days after each intervention. The test started at 20/60 and continued until three letters were missed on a line. | 10 +/- 2 days | 
| Dynamic Visual Acuity | Dynamic VA was determined using a custom-made iPad application. The subject was instructed to hold the iPad at 40cm and presented with a Landolt C surrounded by crowding bars for 0.3s each, starting from 0.5 LogMAR and progressing to smaller sizes using a staircase threshold method. Testing was performed binocularly 10+/-2 days after each intervention | 10 +/- 2 days |