Toric Contact Lens Digital Performance and Comfort Study

Sponsor
Kathryn Richdale (Other)
Overall Status
Recruiting
CT.gov ID
NCT04772560
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
21.5
Anticipated Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study seeks to quantify digital visual performance and subjective visual acceptance of toric contact lenses as compared to spherical lenses in low to moderate astigmatic patients.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: Precision1 for Astigmatism
  • Device: Precision1 Sphere
N/A

Detailed Description

This study seeks to quantify the near visual performance and subjective visual acceptance of toric contact lenses as compared to spherical lenses in an astigmatic cohort of patients. Primary Hypotheses: Subjects will have better near visual acuity and near visual performance with toric, as opposed to spherical, contact lens correction. As such, the following hypotheses will be tested: H01: There is no statistically significant difference in near visual acuity or near vision performance between contact lenses corrections Ha1: There is a statistically significant difference in visual acuity or vision performance between contact lenses corrections

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Toric Contact Lens Digital Performance and Comfort Study
Actual Study Start Date :
Mar 16, 2021
Anticipated Primary Completion Date :
Oct 30, 2021
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

ArmIntervention/Treatment
Experimental: Toric, Then Sphere

Participants who received Toric contact lenses first and spherical lenses after 10 days

Device: Precision1 for Astigmatism
Daily disposable soft toric contact lens

Device: Precision1 Sphere
Daily disposable soft spherical contact lens

Experimental: Sphere, Then Toric

Participants who received Spherical contact lenses first and Toric lenses after 10 days

Device: Precision1 for Astigmatism
Daily disposable soft toric contact lens

Device: Precision1 Sphere
Daily disposable soft spherical contact lens

Outcome Measures

Primary Outcome Measures

  1. Near Visual LogMAR Acuity [10 +/- 2 days]

    High contrast LogMAR visual acuity was assessed at 40 cm using the M&S Clinical Trial Suite system (Niles, Illinois, USA). The system was calibrated according to the manufacturer's directions every day, prior to use. Testing was performed binocularly. The test started at 20/60 and continued until three letters were missed on a line.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 39 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • 18 to 39 years of age (inclusive)

  • pl to -6.00D vertexed sphere power and -0.75 to -1.50D vertexed refractive cylinder OD and OS

  • Best corrected acuity of 20/25 or better in each eye

  • Self-report of at least 4 hrs/day using digital devices

  • No history of ocular pathology or surgery

  • No binocular vision disorder (i.e., tropia, convergence or accommodative insufficiency)

  • No gas permeable lens wear for at least 3 months

  • Current/established full time (>6 days week, >8 hours/day) soft contact lens wearer

  • Asymptomatic soft contact lens wearer (CLDEQ-8 score <12 at baseline)

  • Willing to wear lenses at least 8 hours each day during the study period

  • Not an optometrist

  • Able to speak and read English at a high school level / have at least a high school diploma or equivalent (by self-report)

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1University of Houston College of OptometryHoustonTexasUnited States77204

Sponsors and Collaborators

  • Kathryn Richdale

Investigators

  • Principal Investigator: Kathryn Richdale, University of Houston College of Optometry

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kathryn Richdale, Associate professor, University of Houston
ClinicalTrials.gov Identifier:
NCT04772560
Other Study ID Numbers:
  • STUDY00002753
First Posted:
Feb 26, 2021
Last Update Posted:
Aug 19, 2021
Last Verified:
Aug 1, 2021
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.:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 19, 2021