Back to resultsToric Contact Lens Digital Performance and Comfort Study
Primary Purpose
Astigmatism
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Precision1 for Astigmatism
Precision1 Sphere
Sponsored by
About this trial
This is an interventional treatment trial for Astigmatism
Eligibility Criteria
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)
Sites / Locations
- University of Houston College of Optometry
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Toric, Then Sphere
Sphere, Then Toric
Arm 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
Outcomes
Primary Outcome Measures
Near Visual LogMAR Acuity
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.
Dynamic Visual Acuity
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04772560
Brief Title
Toric Contact Lens Digital Performance and Comfort Study
Official Title
Toric Contact Lens Digital Performance and Comfort Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
March 16, 2021 (Actual)
Primary Completion Date
December 13, 2021 (Actual)
Study Completion Date
December 13, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kathryn Richdale
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.
Yes
Data Monitoring Committee
No
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Astigmatism
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Toric, Then Sphere
Arm Type
Experimental
Arm Description
Participants who received Toric contact lenses first and spherical lenses after 10 days
Arm Title
Sphere, Then Toric
Arm Type
Experimental
Arm Description
Participants who received Spherical contact lenses first and Toric lenses after 10 days
Intervention Type
Device
Intervention Name(s)
Precision1 for Astigmatism
Intervention Description
Daily disposable soft toric contact lens
Intervention Type
Device
Intervention Name(s)
Precision1 Sphere
Intervention Description
Daily disposable soft spherical contact lens
Primary Outcome Measure Information:
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
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathryn Richdale
Organizational Affiliation
University of Houston College of Optometry
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Houston College of Optometry
City
Houston
State/Province
Texas
ZIP/Postal Code
77204
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Toric Contact Lens Digital Performance and Comfort Study
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