Toric Contact Lens Performance Study
1 other identifier
interventional
35
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 18, 2018
CompletedFirst Posted
Study publicly available on registry
June 6, 2018
CompletedStudy Start
First participant enrolled
June 18, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 21, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 21, 2018
CompletedResults Posted
Study results publicly available
June 7, 2021
CompletedJune 7, 2021
June 1, 2021
6 months
May 18, 2018
January 7, 2021
June 4, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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.
10 +/- 2 days
Study Arms (2)
Toric, Then Sphere
EXPERIMENTALParticipants who received Toric contact lenses first and spherical lenses after 10 days
Sphere, Then Toric
EXPERIMENTALParticipants who received Spherical contact lenses first and Toric lenses after 10 days
Interventions
Daily disposable soft toric contact lens
Daily disposable soft spherical contact lens
Eligibility Criteria
You may qualify if:
- +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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Houston College of Optometry
Houston, Texas, 77204, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Kathryn Richdale OD, PhD
- Organization
- University of Houston
Study Officials
- PRINCIPAL INVESTIGATOR
Kathryn Richdale, OD, PhD
University of Houston College of Optometry
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
May 18, 2018
First Posted
June 6, 2018
Study Start
June 18, 2018
Primary Completion
December 21, 2018
Study Completion
December 21, 2018
Last Updated
June 7, 2021
Results First Posted
June 7, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will not share