Toric Contact Lens Performance Study
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 |
---|---|---|
|
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
Arms and Interventions
Arm | Intervention/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
- 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
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
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University of Houston College of Optometry | Houston | Texas | United States | 77204 |
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.- Study00000682
Study Results
Participant Flow
Recruitment Details | 37 participants were screened for eligibility between March and November 2018. |
---|---|
Pre-assignment Detail | 35 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 Title | Toric, Then Sphere | Sphere, Then Toric |
---|---|---|
Arm/Group Description | Participants who received Toric contact lenses first and spherical lenses after 10 days | Participants who received Sphere contact lenses first and Toric lenses after 10 days |
Period Title: Overall Study | ||
STARTED | 18 | 17 |
COMPLETED | 17 | 17 |
NOT COMPLETED | 1 | 0 |
Baseline Characteristics
Arm/Group Title | All Study Participants |
---|---|
Arm/Group Description | Toric 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 Participants | 34 |
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
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 |
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 Title | Toric | Sphere |
---|---|---|
Arm/Group Description | Participants who wore Toric contact lenses for 10 days | Participants who wore Spherical contact lenses for 10 days |
Measure Participants | 34 | 34 |
Mean (Standard Deviation) [LogMAR] |
-0.09
(0.07)
|
-0.02
(0.09)
|
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 | Sphere | ||
Arm/Group Description | Soft toric contact lens Dailies Aqua Comfort Plus Toric: Daily disposable soft toric contact lens | Soft sphere contact lens Dailies Aqua Comfort Plus Sphere: Daily disposable soft spherical contact lens | ||
All Cause Mortality |
||||
Toric | Sphere | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/34 (0%) | 0/34 (0%) | ||
Serious Adverse Events |
||||
Toric | Sphere | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/34 (0%) | 0/34 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
Toric | Sphere | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 1/34 (2.9%) | 0/34 (0%) | ||
Eye disorders | ||||
Keratitis | 1/34 (2.9%) | 1 | 0/34 (0%) | 0 |
Limitations/Caveats
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 |
richdale@central.uh.edu |
- Study00000682