Astigmatism Bilateral
Conditions
Keywords
contact lenses, astigmatism
Brief summary
Comparison of wear experience with daily disposable and monthly replacement soft contact lenses in contact lens wearers who have astigmatism.
Interventions
DEVICEDaily disposable toric soft contact lens
Daily disposable toric soft contact lens
DEVICEMonthly replacement toric daily wear soft contact lens
Monthly replacement toric daily wear soft contact lens
Sponsors
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects must be current soft lens wearers in both eyes. * Subjects must have 20/25 or better distance visual acuity with current lenses (entering acuity). * Good general health (defined by medication use that has not changed within the last month and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the PI) * Ability to give informed consent * Willing to spend time for the study. Subjects will be required to attend two study visits and wear contact lenses on days between study visits. * Either gender * Any racial or ethnic origin
Exclusion criteria
* Participants cannot be pregnant or lactating. * Participants cannot be current wearers of the study lenses * No current ocular inflammation or infection as assessed by the study investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale Survey of Overall Comfort | 1 month | Visual analog scale survey of comfort from 0 to 100, with 0 anchored as poor and 100 as excellent |
Countries
United States
Participant flow
Pre-assignment details
There were 4 screen failures at the first visit.
Participants by arm
| Arm | Count |
|---|---|
| Daily Disposable Lens Worn First, Reusable Lens Worn Second Subject will wear contact lenses for 30 days during the day only.
Daily disposable toric soft contact lens: Daily disposable toric soft contact lens
Monthly replacement toric daily wear soft contact lens: Monthly replacement toric daily wear soft contact lens | 28 |
| Reusable Lens Worn First, Daily Disposable Lens Worn Second Subject will wear contact lenses for 30 days during the day only.
Daily disposable toric soft contact lens: Daily disposable toric soft contact lens
Monthly replacement toric daily wear soft contact lens: Monthly replacement toric daily wear soft contact lens | 31 |
| Total | 59 |
Baseline characteristics
| Characteristic | Daily Disposable Lens Worn First, Reusable Lens Worn Second | Reusable Lens Worn First, Daily Disposable Lens Worn Second | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 28 Participants | 31 Participants | 59 Participants |
| Age, Continuous | 31 years STANDARD_DEVIATION 10.8 | 31.9 years STANDARD_DEVIATION 9.2 | 31.5 years STANDARD_DEVIATION 10 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 4 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants | 27 Participants | 52 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 5 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 22 Participants | 24 Participants | 46 Participants |
| Region of Enrollment United States | 28 Participants | 31 Participants | 59 Participants |
| Sex/Gender, Customized Female | 18 Participants | 16 Participants | 34 Participants |
| Sex/Gender, Customized Male | 10 Participants | 12 Participants | 22 Participants |
| Sex/Gender, Customized Nonbinary | 0 Participants | 1 Participants | 1 Participants |
| Sex/Gender, Customized Transgender Female | 0 Participants | 1 Participants | 1 Participants |
| Sex/Gender, Customized Transgender Male | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 63 | 0 / 61 |
| other Total, other adverse events | 0 / 63 | 0 / 61 |
| serious Total, serious adverse events | 0 / 63 | 0 / 61 |
Outcome results
Primary
Visual Analog Scale Survey of Overall Comfort
Visual analog scale survey of comfort from 0 to 100, with 0 anchored as poor and 100 as excellent
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Daily Disposable Lens | Visual Analog Scale Survey of Overall Comfort | 71.6 units on a scale | Standard Deviation 26.3 |
| Reusable Lens | Visual Analog Scale Survey of Overall Comfort | 63.2 units on a scale | Standard Deviation 28.9 |