Toric Contact Lens Digital Performance and Comfort Study

Sponsor
Kathryn Richdale (Other)
Overall Status
Completed
CT.gov ID
NCT04772560
Collaborator
(none)
30
1
2
8.9
3.4

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 Disease Intervention/Treatment Phase
  • 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
Actual 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
Actual Primary Completion Date :
Dec 13, 2021
Actual Study Completion Date :
Dec 13, 2021

Arms and Interventions

Arm Intervention/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 10+/-2 days after each intervention. The test started at 20/60 and continued until three letters were missed on a line.

  2. Dynamic Visual Acuity [10 +/- 2 days]

    Dynamic VA was determined using a custom-made iPad application. The subject was instructed to hold the iPad at 40cm and presented with a Landolt C surrounded by crowding bars for 0.3s each, starting from 0.5 LogMAR and progressing to smaller sizes using a staircase threshold method. Testing was performed binocularly 10+/-2 days after each intervention

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

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

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

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

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

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

Enclusion Criteria:
  • History of ocular pathology or surgery

  • Binocular vision disorder (i.e., tropia, convergence or accommodative insufficiency)

  • Gas permeable lens wear for at least 3 months

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Houston College of Optometry Houston Texas United States 77204

Sponsors and Collaborators

  • Kathryn Richdale

Investigators

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

Study Documents (Full-Text)

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:
Mar 10, 2022
Last Verified:
Feb 1, 2022
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

Participant Flow

Recruitment Details 30 participants were screened for eligibility between March and December 2021
Pre-assignment Detail 23 of 30 participants were randomized. Of those not randomized, 7 did not meet inclusion criteria.
Arm/Group Title Toric Then Spherical Spherical Then Toric
Arm/Group Description Participants who received toric contact lenses first and spherical lenses after 10 days Participants who received spherical contact lenses first and toric lenses after 10 days
Period Title: Overall Study
STARTED 11 12
COMPLETED 11 12
NOT COMPLETED 0 0

Baseline Characteristics

Arm/Group Title All Participants
Arm/Group Description 23 participants who had completed the study
Overall Participants 23
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
24.4
(4.2)
Sex: Female, Male (Count of Participants)
Female
17
73.9%
Male
6
26.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
9
39.1%
Not Hispanic or Latino
14
60.9%
Unknown or Not Reported
0
0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
1
4.3%
Asian
8
34.8%
Native Hawaiian or Other Pacific Islander
0
0%
Black or African American
3
13%
White
11
47.8%
More than one race
0
0%
Unknown or Not Reported
0
0%
Region of Enrollment (participants) [Number]
United States
23
100%

Outcome Measures

1. Primary Outcome
Title Near Visual LogMAR Acuity
Description 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 10+/-2 days after each intervention. The test started at 20/60 and continued until three letters were missed on a line.
Time Frame 10 +/- 2 days

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title All Participants
Arm/Group Description 23 participants who had completed the study
Measure Participants 23
Toric CL
-0.10
(0.02)
Spherical CL
-0.03
(0.21)
2. Primary Outcome
Title Dynamic Visual Acuity
Description Dynamic VA was determined using a custom-made iPad application. The subject was instructed to hold the iPad at 40cm and presented with a Landolt C surrounded by crowding bars for 0.3s each, starting from 0.5 LogMAR and progressing to smaller sizes using a staircase threshold method. Testing was performed binocularly 10+/-2 days after each intervention
Time Frame 10 +/- 2 days

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title All Participants
Arm/Group Description 23 participants who had completed the study
Measure Participants 23
Toric CL
0.04
(0.02)
Spherical CL
0.11
(0.02)

Adverse Events

Time Frame 10 ± 2 days for each intervention
Adverse Event Reporting Description AE information was collected at each study visit
Arm/Group Title Toric Contact Lens Wear Spherical Contact Lens Wear
Arm/Group Description 23 participants had completed the study 23 participants had completed the study
All Cause Mortality
Toric Contact Lens Wear Spherical Contact Lens Wear
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/23 (0%) 0/23 (0%)
Serious Adverse Events
Toric Contact Lens Wear Spherical Contact Lens Wear
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/23 (0%) 0/23 (0%)
Other (Not Including Serious) Adverse Events
Toric Contact Lens Wear Spherical Contact Lens Wear
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 4/23 (17.4%) 0/23 (0%)
Eye disorders
Corneal staining 3/23 (13%) 3 0/23 (0%) 0
Hordeolum 1/23 (4.3%) 1 0/23 (0%) 0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Kathryn Richdale OD, PhD
Organization University of Houston
Phone 713-743-1974
Email richdale@uh.edu
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:
Mar 10, 2022
Last Verified:
Feb 1, 2022