Contact Lens Optics and Visual Performance

This study will evaluate changes in visual performance at different pupil sizes between a single vision soft contact lens and multifocal soft contact lens, and compare refractive error measured between these two lenses with an autorefractor and an aberrometer

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 24
• 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
• Genders Eligible for Study: All

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 -8.00D 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
• 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
Other: Single vision contact lens; Subjects will wear a single vision soft contact lens during the study visit	Device: Single vision contact lens; Subjects will wear a single vision soft contact lens only during the study visit; Other Names: comfilcon A
Other: Multifocal contact lens; Subjects will wear a multifocal soft contact lens during the study visit	Device: Multifocal contact lens; Subjects will wear a multifocal soft contact lens only 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 performance will be measured at different pupil sizes for each subject while wearing each of the two lenses	Through completion of study visit, an average of 3 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Refractive error	Refractive error will be measured with an autorefractor and an aberrometer with subjects wearing each of the two lenses	Through completion of study visit, an average of 3 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): June 13, 2022
• Primary Completion (Actual): July 27, 2022
• Study Completion (Actual): July 27, 2022

Study Registration Dates

• First Submitted: March 24, 2022
• First Submitted That Met QC Criteria: March 24, 2022
• First Posted (Actual): April 1, 2022

Study Record Updates

• Last Update Posted (Actual): August 9, 2022
• Last Update Submitted That Met QC Criteria: August 6, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: STUDY00003513

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