Toric Contact Lens Performance Study

NCT ID: NCT03546647

Last Updated: 2021-06-07

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-18

Study Completion Date

2018-12-21

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.

Conditions

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Astigmatism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Toric, Then Sphere

Participants who received Toric contact lenses first and spherical lenses after 10 days

Group Type EXPERIMENTAL

Dailies Aqua Comfort Plus Toric

Intervention Type DEVICE

Daily disposable soft toric contact lens

Dailies Aqua Comfort Plus Sphere

Intervention Type DEVICE

Daily disposable soft spherical contact lens

Sphere, Then Toric

Participants who received Spherical contact lenses first and Toric lenses after 10 days

Group Type EXPERIMENTAL

Dailies Aqua Comfort Plus Toric

Intervention Type DEVICE

Daily disposable soft toric contact lens

Dailies Aqua Comfort Plus Sphere

Intervention Type DEVICE

Daily disposable soft spherical contact lens

Interventions

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Dailies Aqua Comfort Plus Toric

Daily disposable soft toric contact lens

Intervention Type DEVICE

Dailies Aqua Comfort Plus Sphere

Daily disposable soft spherical contact lens

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

+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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Houston

OTHER

Sponsor Role lead

Responsible Party

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Kathryn Richdale

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kathryn Richdale, OD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Houston College of Optometry

Locations

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University of Houston College of Optometry

Houston, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Informed Consent Form

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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Study00000682

Identifier Type: -

Identifier Source: org_study_id

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