Clinical Comparison of Two Daily Disposable Contact Lenses
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Alcon Research
- Enrollment
- 170
- Locations
- 8
- Primary Endpoint
- Least Squares Mean Distance VA (logMAR) With Study Lenses
Study Overview
Brief Summary
The purpose of this study is to compare the clinical performance of PRECISION1™ contact lenses to Clariti® 1 day contact lenses.
Detailed Description
Subjects will be expected to attend 3 study visits and wear the study lenses daily for at least 10 hours per day. On the day prior to Visits 2 and 3, subjects will be expected to wear the study lenses for at least 16 hours. The total duration of subject participation will be up to 22 days.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Successful wearer of spherical soft contact lenses with at least 3 months wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day.
- •Possess spectacles and willing to wear habitual spectacles for vision correction when study lenses are not worn, as needed.
- •Willing to wear contact lenses for at least 16 hours on one of the days (day prior to each week 1 visit).
- •Other protocol-specified inclusion criteria may apply.
Exclusion Criteria
- •Habitual PRECISION1, Clariti 1-Day, and DAILIES TOTAL1 contact lens wearers.
- •Any monovision and multifocal lens wearers.
- •Other protocol-specified exclusion criteria may apply.
Arms & Interventions
PRECISION1, then Clariti 1-Day
Verofilcon A contact lenses worn first, with somofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 days in a daily disposable modality.
Intervention: Somofilcon A contact lenses (Device)
PRECISION1, then Clariti 1-Day
Verofilcon A contact lenses worn first, with somofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 days in a daily disposable modality.
Intervention: Verofilcon A contact lenses (Device)
Clariti 1-Day, then PRECISION1
Somofilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 days in a daily disposable modality.
Intervention: Verofilcon A contact lenses (Device)
Clariti 1-Day, then PRECISION1
Somofilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 days in a daily disposable modality.
Intervention: Somofilcon A contact lenses (Device)
Outcomes
Primary Outcomes
Least Squares Mean Distance VA (logMAR) With Study Lenses
Time Frame: Day 8, each study lens type
Distance visual acuity (VA) was assessed with study lenses in place. VA was collected for each eye separately using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity.
Secondary Outcomes
No secondary outcomes reported