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

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: Single vision contact lens; Device: Multifocal contact lens

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77204
      • University of Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: Single vision contact lens; Participants will wear a single vision soft contact lens during the study visit; Other Names: comfilcon A; Device: Multifocal contact lens; Participants will wear a multifocal soft contact lens during the study visit; Other Names: comfilcon A
Experimental: 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	Device: Single vision contact lens; Participants will wear a single vision soft contact lens during the study visit; Other Names: comfilcon A; Device: Multifocal contact lens; Participants will wear a multifocal soft contact lens during the study visit; Other Names: comfilcon A

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Performance	Low contrast visual acuity was measured for each participant while wearing each of the two lenses	Through completion of study visit, an average of 2.5 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spherical Equivalent Refractive Error On-axis	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.	Through completion of study visit, an average of 2.5 hours
Spherical Equivalent Refractive Error at 30 Degrees Temporal Retina	Cycloplegic spherical equivalent refractive error was measured 3 times with an aberrometer and averaged.	Through completion of study visit, an average of 2.5 hours
Spherical Equivalent Refractive Error at 20 Degrees Temporal Retina	Cycloplegic spherical equivalent refractive error was measured 3 times with an aberrometer and averaged.	Through completion of study visit, an average of 2.5 hours
Spherical Equivalent Refractive Error at 20 Degrees Nasal Retina	Cycloplegic spherical equivalent refractive error was measured 3 times with an aberrometer and averaged.	Through completion of study visit, an average of 2.5 hours
Spherical Equivalent Refractive Error at 30 Degrees Nasal Retina	Cycloplegic spherical equivalent refractive error was measured 3 times with an aberrometer and averaged.	Through completion of study visit, an average of 2.5 hours

Collaborators and Investigators

• Sponsor: David A Berntsen, OD PhD
• Investigators: Principal Investigator: David A Berntsen, OD, PhD, University of Houston College of Optometry

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2022
• Primary Completion (Actual): December 13, 2022
• Study Completion (Actual): December 13, 2022

Study Registration Dates

• First Submitted: August 25, 2021
• First Submitted That Met QC Criteria: August 25, 2021
• First Posted (Actual): August 31, 2021

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 2, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: STUDY00002545

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No