Back to resultsToric Contact Lens Performance Study
Primary Purpose
Astigmatism
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dailies Aqua Comfort Plus Toric
Dailies Aqua Comfort Plus Sphere
Sponsored by
About this trial
This is an interventional treatment trial for Astigmatism
Eligibility Criteria
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)
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. The test started at 20/200 and continued until three letters were missed on a line.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03546647
Brief Title
Toric Contact Lens Performance Study
Official Title
Toric Contact Lens Performance Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
June 18, 2018 (Actual)
Primary Completion Date
December 21, 2018 (Actual)
Study Completion Date
December 21, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Houston
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.
No
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 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.
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
35 (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)
Dailies Aqua Comfort Plus Toric
Intervention Description
Daily disposable soft toric contact lens
Intervention Type
Device
Intervention Name(s)
Dailies Aqua Comfort Plus 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. The test started at 20/200 and continued until three letters were missed on a line.
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
+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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathryn Richdale, OD, PhD
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
Plan to Share IPD
No
Learn more about this trial
Toric Contact Lens Performance Study
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