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OpenTrials
Completed

NCT Number: NCT05028790

Evaluating Contact Lens Optics

This study will evaluate changes in refractive error and visual performance between a single vision soft contact lens and multifocal soft contact lens

Completed

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Key information

Conditions

Myopia 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

Houston, Texas, 77204, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Able to read and understand the informed consent document
  • 18 to 39 years of age (inclusive)
  • Best corrected visual acuity of 20/25 or better in the right eye
  • Refractive error from -1.00D to -6.00D with astigmatism less than or equal to -1.00D in the right eye (corneal plane)

Exclusion criteria

  • Any ocular or systemic conditions affecting vision, refraction, or the ability to wear a soft contact lens
  • History of ocular trauma or surgery causing abnormal or distorted vision
  • Current Rigid Gas Permeable (RGP) contact lens wearers
  • Unwilling to have contact lens fit photographed
  • Pregnant and/or lactating females, by self-report

Treatment and study plan

Single vision Contact lens

Device

Participants will wear a single vision soft contact lens during the study visit

Other names: comfilcon A

Multifocal Contact Lens

Device

Participants will wear a multifocal soft contact lens during the study visit

Other names: comfilcon A

Primary outcomes

  1. Visual Performance

    Time frame: Through completion of study visit, an average of 2.5 hours

    Low contrast visual acuity was measured for each participant while wearing each of the two lenses

Secondary outcomes

  1. Spherical Equivalent Refractive Error On-axis

    Time frame: Through completion of study visit, an average of 2.5 hours

    Refraction was measured after cycloplegia with two drops of 1% tropicamide hydrochloride. Spherical equivalent refractive error was then measured 3 times with an aberrometer and averaged.

  2. Spherical Equivalent Refractive Error at 30 Degrees Temporal Retina

    Time frame: Through completion of study visit, an average of 2.5 hours

    Cycloplegic spherical equivalent refractive error was measured 3 times with an aberrometer and averaged.

  3. Spherical Equivalent Refractive Error at 20 Degrees Temporal Retina

    Time frame: Through completion of study visit, an average of 2.5 hours

    Cycloplegic spherical equivalent refractive error was measured 3 times with an aberrometer and averaged.

  4. Spherical Equivalent Refractive Error at 20 Degrees Nasal Retina

    Time frame: Through completion of study visit, an average of 2.5 hours

    Cycloplegic spherical equivalent refractive error was measured 3 times with an aberrometer and averaged.

  5. Spherical Equivalent Refractive Error at 30 Degrees Nasal Retina

    Time frame: Through completion of study visit, an average of 2.5 hours

    Cycloplegic spherical equivalent refractive error was measured 3 times with an aberrometer and averaged.

Sponsors and collaborators

Lead sponsor

David A Berntsen, OD PhD

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 31, 2021
Registry last updated
Feb 6, 2024

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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