Astigmatism of Both Eyes, Contact Lens
Conditions
Keywords
Toric Contact Lens, Daily Contact Lens
Brief summary
This study is evaluating the wear experience of a daily toric contact lens after 10, 12, 14, and 16 hours of lens wear.
Interventions
DEVICEPrecision1® Daily Disposable Toric Contact Lens
Soft, toric contact lens used to correct distance vision and astigmatism.
Sponsors
Alcon Research
Ohio State University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Must be current soft toric contact lens wearers with longs days of lens wear within the parameters of Precision1® lenses available. * Distance visual acuity of 20/25 or better with current lenses. * Recent eye exam in the last year. * 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. * Must have a working smart phone or device and be willing to receive and respond to texts and/or emails. * Willing to spend time for the study, which includes three in-person study visits (with a possible fourth visit if needed), wearing contact lenses on days between study visits, and responding to communications on a smart phone or other electronic device on five weekdays between Visits 2 and 3.
Exclusion criteria
* Current ocular inflammation or infection as assessed by the study investigator. * Currently pregnant, lactating, or planning to become pregnant during the course of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Vision in Contact Lenses Assessed Using a 1 to 10 Scale After 16 Hours of Wear in One Day (After up to 14 Days of Wear) | Assessment is taken at the 16 hour of wear time point in a single day, after up to 14 days of wear. | 1 describes poor experience, and 10 describes excellent experience. |
| Subjective Comfort on a 1-10 Scale After 16 Hours of Wear in One Day (After up to 14 Days of Wear) | Taken at the 16 hour of wear time point in a single day, after up to 14 days of wear Up to 14 days | 1 describes poor experience, and 10 describes excellent experience. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Daily Disposable Toric Contact Lens All subjects are fit into Precision1® toric contact lenses. Subjects are requested to wear the lenses for a total of two weeks.
Precision1® Daily Disposable Toric Contact Lens: Soft, toric contact lens used to correct distance vision and astigmatism. | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Daily Disposable Toric Contact Lens |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants |
| Age, Continuous | 28.4 years STANDARD_DEVIATION 6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 21 Participants |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
Subjective Comfort on a 1-10 Scale After 16 Hours of Wear in One Day (After up to 14 Days of Wear)
1 describes poor experience, and 10 describes excellent experience.
Time frame: Taken at the 16 hour of wear time point in a single day, after up to 14 days of wear Up to 14 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Daily Disposable Toric Contact Lens | Subjective Comfort on a 1-10 Scale After 16 Hours of Wear in One Day (After up to 14 Days of Wear) | 8.4 units on a scale |
Primary
Subjective Vision in Contact Lenses Assessed Using a 1 to 10 Scale After 16 Hours of Wear in One Day (After up to 14 Days of Wear)
1 describes poor experience, and 10 describes excellent experience.
Time frame: Assessment is taken at the 16 hour of wear time point in a single day, after up to 14 days of wear.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Daily Disposable Toric Contact Lens | Subjective Vision in Contact Lenses Assessed Using a 1 to 10 Scale After 16 Hours of Wear in One Day (After up to 14 Days of Wear) | 9 units on a scale |