Back to resultsContact Lens Optics and Visual Performance
Primary Purpose
Myopia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Single vision contact lens
Multifocal contact lens
Sponsored by
About this trial
This is an interventional other trial for Myopia
Eligibility Criteria
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
Sites / Locations
- University of Houston
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Single vision contact lens
Multifocal contact lens
Arm Description
Subjects will wear a single vision soft contact lens during the study visit
Subjects will wear a multifocal soft contact lens during the study visit
Outcomes
Primary Outcome Measures
Visual performance
Low contrast visual performance will be measured at different pupil sizes for each subject while wearing each of the two lenses
Secondary Outcome Measures
Refractive error
Refractive error will be measured with an autorefractor and an aberrometer with subjects wearing each of the two lenses
Full Information
NCT ID
NCT05308069
First Posted
March 24, 2022
Last Updated
August 6, 2022
Sponsor
David A Berntsen, OD PhD
1. Study Identification
Unique Protocol Identification Number
NCT05308069
Brief Title
Contact Lens Optics and Visual Performance
Official Title
Contact Lens Optics and Visual Performance
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
June 13, 2022 (Actual)
Primary Completion Date
July 27, 2022 (Actual)
Study Completion Date
July 27, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
David A Berntsen, OD PhD
4. Oversight
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
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single vision contact lens
Arm Type
Other
Arm Description
Subjects will wear a single vision soft contact lens during the study visit
Arm Title
Multifocal contact lens
Arm Type
Other
Arm Description
Subjects will wear a multifocal soft contact lens during the study visit
Intervention Type
Device
Intervention Name(s)
Single vision contact lens
Other Intervention Name(s)
comfilcon A
Intervention Description
Subjects will wear a single vision soft contact lens only during the study visit
Intervention Type
Device
Intervention Name(s)
Multifocal contact lens
Other Intervention Name(s)
comfilcon A
Intervention Description
Subjects will wear a multifocal soft contact lens only during the study visit
Primary Outcome Measure Information:
Title
Visual performance
Description
Low contrast visual performance will be measured at different pupil sizes for each subject while wearing each of the two lenses
Time Frame
Through completion of study visit, an average of 3 hours
Secondary Outcome Measure Information:
Title
Refractive error
Description
Refractive error will be measured with an autorefractor and an aberrometer with subjects wearing each of the two lenses
Time Frame
Through completion of study visit, an average of 3 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David A Berntsen, OD, PhD
Organizational Affiliation
University of Houston College of Optometry
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77204
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Contact Lens Optics and Visual Performance
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