Astigmatism, Refractive Errors
Conditions
Keywords
Contact lenses, Daily disposable
Brief summary
The purpose of this study to evaluate the overall performance of PRECISION1™ for Astigmatism contact lenses with MyDay® Toric contact lenses.
Detailed description
Subjects will be expected to attend 4 visits and wear study lenses daily for approximately 10 hours per day. On the day prior to the Week 1 Follow-up visit of each crossover period, subjects will be asked to wear the respective study lens for at least 16 hours. The expected duration of subject participation in the study is approximately 3 weeks.
Interventions
Soft contact lenses for optical correction of astigmatism, used as indicated
DEVICEStenfilcon A toric contact lenses
Soft contact lenses for optical correction of astigmatism, used as indicated
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Successful wear of toric soft contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months. * Willing to wear study contact lenses for at least 16 hours on the day prior to the Week 1 Follow up visit of each lens type. * Other protocol-defined inclusion criteria may apply. Key
Exclusion criteria
* Current/previous wear of PRECISION1 for Astigmatism or MyDay Toric contact lenses. * Current wear of spherical contact lenses. * Wears habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week). * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of lenses with axis orientation within ±30 degrees inclusive from the intended axis, 10 minutes after lens insertion | Day 1, 10 minutes after lens insertion, each product | Axis orientation (orientation of the scribe mark) will be assessed by slit lamp examination and recorded as deviations from intended axis. |
Countries
United States
Outcome results
None listed