Toric Contact Lens Performance Study

Sponsor
University of Houston (Other)
Overall Status
Completed
CT.gov ID
NCT03546647
Collaborator
(none)
35
Enrollment
1
Location
2
Arms
6.1
Actual Duration (Months)
5.7
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: Dailies Aqua Comfort Plus Toric
  • Device: Dailies Aqua Comfort Plus Sphere
N/A

Detailed Description

This is a prospective, single site, randomized, masked, crossover study. This study will evaluate the ability of toric contact lenses to decrease signs and symptoms of asthenopia and improve digital reading performance. Symptoms and objective near vision outcomes will be measured at baseline and after 1 week of wear with each correction.

Study Design

Study Type:
Interventional
Actual Enrollment :
35 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Toric Contact Lens Performance Study
Actual Study Start Date :
Jun 18, 2018
Actual Primary Completion Date :
Dec 21, 2018
Actual Study Completion Date :
Dec 21, 2018

Arms and Interventions

ArmIntervention/Treatment
Experimental: Toric, Then Sphere

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

Device: Dailies Aqua Comfort Plus Toric
Daily disposable soft toric contact lens

Device: Dailies Aqua Comfort Plus 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: Dailies Aqua Comfort Plus Toric
Daily disposable soft toric contact lens

Device: Dailies Aqua Comfort Plus 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 20/200 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

+6.00 to -6.00 D vertexed sphere power and -0.75 to -1.50 D vertexed refractive cylinder in the right and left eyes Best corrected acuity of 20/25 or better in each eye Self report of at least 4 hrs/day using digital devices Current/established soft contact lens wearer (has worn contact lenses in the past year)

Exclusion An optometrist or optometry student 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 Presbyopic (based on refraction)

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1University of Houston College of OptometryHoustonTexasUnited States77204

Sponsors and Collaborators

  • University of Houston

Investigators

  • Principal Investigator: Kathryn Richdale, OD, PhD, 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:
NCT03546647
Other Study ID Numbers:
  • Study00000682
First Posted:
Jun 6, 2018
Last Update Posted:
Jun 7, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details37 participants were screened for eligibility between March and November 2018.
Pre-assignment Detail35 of 37 participants were randomized. Of those not randomized, 2 did not meet inclusion criteria. One randomized subject was removed from the study due to an adverse event.
Arm/Group TitleToric, Then SphereSphere, Then Toric
Arm/Group DescriptionParticipants who received Toric contact lenses first and spherical lenses after 10 daysParticipants who received Sphere contact lenses first and Toric lenses after 10 days
Period Title: Overall Study
STARTED1817
COMPLETED1717
NOT COMPLETED10

Baseline Characteristics

Arm/Group TitleAll Study Participants
Arm/Group DescriptionToric group: Participants who received Toric contact lenses first and spherical lenses after 10 days Sphere group: Participants who received spherical contact lenses first and Toric lenses after 10 days
Overall Participants34
Age, Customized (years) [Mean (Standard Deviation) ]
Male
22.2
(2.7)
Female
27.5
(5.3)
Sex: Female, Male (Count of Participants)
Female
26
76.5%
Male
8
23.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
19
55.9%
Not Hispanic or Latino
15
44.1%
Unknown or Not Reported
0
0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
Asian
6
17.6%
Native Hawaiian or Other Pacific Islander
1
2.9%
Black or African American
7
20.6%
White
18
52.9%
More than one race
0
0%
Unknown or Not Reported
2
5.9%
Region of Enrollment (participants) [Number]
United States
34
100%

Outcome Measures

1. Primary Outcome
TitleNear Visual LogMAR Acuity
DescriptionHigh 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 20/200 and continued until three letters were missed on a line.
Time Frame10 +/- 2 days

Outcome Measure Data

Analysis Population Description
All participants who received each intervention and completed all study visits were included in the efficacy analysis.
Arm/Group TitleToricSphere
Arm/Group DescriptionParticipants who wore Toric contact lenses for 10 daysParticipants who wore Spherical contact lenses for 10 days
Measure Participants3434
Mean (Standard Deviation) [LogMAR]
-0.09
(0.07)
-0.02
(0.09)

Adverse Events

Time Frame10 ± 2 days for each intervention
Adverse Event Reporting Description AE information was collected at each study visit
Arm/Group TitleToricSphere
Arm/Group DescriptionSoft toric contact lens Dailies Aqua Comfort Plus Toric: Daily disposable soft toric contact lensSoft sphere contact lens Dailies Aqua Comfort Plus Sphere: Daily disposable soft spherical contact lens
All Cause Mortality
ToricSphere
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/34 (0%) 0/34 (0%)
Serious Adverse Events
ToricSphere
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/34 (0%) 0/34 (0%)
Other (Not Including Serious) Adverse Events
ToricSphere
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total1/34 (2.9%) 0/34 (0%)
Eye disorders
Keratitis1/34 (2.9%) 10/34 (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/TitleKathryn Richdale OD, PhD
OrganizationUniversity of Houston
Phone713-743-1974
Emailrichdale@central.uh.edu
Responsible Party:
Kathryn Richdale, Associate Professor, University of Houston
ClinicalTrials.gov Identifier:
NCT03546647
Other Study ID Numbers:
  • Study00000682
First Posted:
Jun 6, 2018
Last Update Posted:
Jun 7, 2021
Last Verified:
Jun 1, 2021