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OpenTrials
Completed

NCT Number: NCT03546647

Toric Contact Lens Performance Study

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.

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Key information

Conditions

Astigmatism Eye Diseases Refractive Errors

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Houston College of Optometry

Houston, Texas, 77204, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Dailies Aqua Comfort Plus Toric

Device

Daily disposable soft toric contact lens

Dailies Aqua Comfort Plus Sphere

Device

Daily disposable soft spherical contact lens

Primary outcomes

  1. Near Visual LogMAR Acuity

    Time frame: 10 +/- 2 days

    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.

Sponsors and collaborators

Lead sponsor

University of Houston

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 6, 2018
Registry last updated
Jun 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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