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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Toric, Then Sphere | Experimental | Participants who received Toric contact lenses first and spherical lenses after 10 days |
|
| Sphere, Then Toric | Experimental | Participants who received Spherical contact lenses first and Toric lenses after 10 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dailies Aqua Comfort Plus Toric | Device | Daily disposable soft toric contact lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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)
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| Name | Affiliation | Role |
|---|---|---|
| Kathryn Richdale, OD, PhD | University of Houston College of Optometry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Houston College of Optometry | Houston | Texas | 77204 | United States |
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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.
37 participants were screened for eligibility between March and November 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | Toric, Then Sphere | Participants who received Toric contact lenses first and spherical lenses after 10 days |
| FG001 | Sphere, Then Toric | Participants who received Sphere contact lenses first and Toric lenses after 10 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All participants who received each intervention and completed all study visits were included in the efficacy analysis. | Posted | Mean | Standard Deviation | LogMAR | 10 +/- 2 days |
|
10 ± 2 days for each intervention
AE information was collected at each study visit
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Toric | Soft toric contact lens Dailies Aqua Comfort Plus Toric: Daily disposable soft toric contact lens |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Keratitis | Eye disorders | Systematic Assessment | superficial punctate keratitis > grade 2 OU |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kathryn Richdale OD, PhD | University of Houston | 713-743-1974 | richdale@central.uh.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Aug 27, 2018 | Jan 5, 2021 | Prot_ICF_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 27, 2018 | Jan 5, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Dailies Aqua Comfort Plus Sphere | Device | Daily disposable soft spherical contact lens |
|
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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Participants who wore Spherical contact lenses for 10 days
|
|
| 0 |
| 34 |
| 0 |
| 34 |
| 1 |
| 34 |
| EG001 | Sphere | Soft sphere contact lens Dailies Aqua Comfort Plus Sphere: Daily disposable soft spherical contact lens | 0 | 34 | 0 | 34 | 0 | 34 |
|
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