Evaluating Contact Lens Optics

NCT ID: NCT05028790

Last Updated: 2024-02-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-27

Study Completion Date

2022-12-13

Brief Summary

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

Detailed Description

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Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants
Participants were masked to the order in which they wore contact lenses

Study Groups

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Single vision soft contact lens first, then multifocal soft contact lens

Participants wore the single vision soft contact lens first, then a multifocal soft contact lens

Group Type EXPERIMENTAL

Single vision contact lens

Intervention Type DEVICE

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

Multifocal contact lens

Intervention Type DEVICE

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

Multifocal soft contact lens first, then single vision soft contact lens

Participants wore the multifocal soft contact lens first, then the single vision soft contact lens

Group Type EXPERIMENTAL

Single vision contact lens

Intervention Type DEVICE

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

Multifocal contact lens

Intervention Type DEVICE

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

Interventions

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Single vision contact lens

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

Intervention Type DEVICE

Multifocal contact lens

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

Intervention Type DEVICE

Other Intervention Names

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comfilcon A comfilcon A

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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David A Berntsen, OD PhD

OTHER

Sponsor Role lead

Responsible Party

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David A Berntsen, OD PhD

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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David A Berntsen, OD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Houston College of Optometry

Locations

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University of Houston

Houston, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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STUDY00002545

Identifier Type: -

Identifier Source: org_study_id

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