Astigmatism
Conditions
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.
Interventions
DEVICEDailies Aqua Comfort Plus Toric
Daily disposable soft toric contact lens
DEVICEDailies Aqua Comfort Plus Sphere
Daily disposable soft spherical contact lens
Sponsors
University of Houston
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 39 Years
Healthy volunteers
Yes
Inclusion 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
37 participants were screened for eligibility between March and November 2018.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 34 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Customized Female | 27.5 years STANDARD_DEVIATION 5.3 |
| Age, Customized Male | 22.2 years STANDARD_DEVIATION 2.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 19 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 18 Participants |
| Region of Enrollment United States | 34 participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 34 |
| other Total, other adverse events | 1 / 34 | 0 / 34 |
| serious Total, serious adverse events | 0 / 34 | 0 / 34 |
Outcome results
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.
Time frame: 10 +/- 2 days
Population: All participants who received each intervention and completed all study visits were included in the efficacy analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Toric | Near Visual LogMAR Acuity | -0.09 LogMAR | Standard Deviation 0.07 |
| Sphere | Near Visual LogMAR Acuity | -0.02 LogMAR | Standard Deviation 0.09 |