NCT05028790

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 31, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

February 27, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2022

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

February 6, 2024

Completed
Last Updated

February 6, 2024

Status Verified

February 1, 2024

Enrollment Period

10 months

First QC Date

August 25, 2021

Results QC Date

November 28, 2023

Last Update Submit

February 2, 2024

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Spherical Equivalent Refractive Error On-axis

    Through completion of study visit, an average of 2.5 hours

  • Spherical Equivalent Refractive Error at 30 Degrees Temporal Retina

    Through completion of study visit, an average of 2.5 hours

  • Spherical Equivalent Refractive Error at 20 Degrees Temporal Retina

    Through completion of study visit, an average of 2.5 hours

  • Spherical Equivalent Refractive Error at 20 Degrees Nasal Retina

    Through completion of study visit, an average of 2.5 hours

  • Spherical Equivalent Refractive Error at 30 Degrees Nasal Retina

    Through completion of study visit, an average of 2.5 hours

Study Arms (2)

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

EXPERIMENTAL

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

Device: Single vision contact lensDevice: Multifocal contact lens

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

EXPERIMENTAL

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

Device: Single vision contact lensDevice: Multifocal contact lens

Interventions

Single vision contact lensDEVICE

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

Also known as: comfilcon A
Multifocal soft contact lens first, then single vision soft contact lensSingle vision soft contact lens first, then multifocal soft contact lens
Multifocal contact lensDEVICE

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

Also known as: comfilcon A
Multifocal soft contact lens first, then single vision soft contact lensSingle vision soft contact lens first, then multifocal soft contact lens

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Able to read and understand the informed consent document
  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Houston

Houston, Texas, 77204, United States

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Results Point of Contact

Title
David A Berntsen, OD PhD
Organization
University of Houston
dberntsen@uh.edu
713-743-5836

Study Officials

  • David A Berntsen, OD, PhD

    University of Houston College of Optometry

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants were masked to the order in which they wore contact lenses
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 25, 2021

First Posted

August 31, 2021

Study Start

February 27, 2022

Primary Completion

December 13, 2022

Study Completion

December 13, 2022

Last Updated

February 6, 2024

Results First Posted

February 6, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)