Clinical Performance of a Silicone Hydrogel Following Six Nights of Extended Wear
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Alcon Research
- Enrollment
- 22
- Locations
- 3
- Primary Endpoint
- Visual Acuity (VA) With Study Lenses, Collected by Eye
Study Overview
Brief Summary
The purpose of this clinical study is to evaluate the on-eye performance of an investigational soft contact lens compared to a commercially available soft contact lens following 1 week of extended wear.
Detailed Description
Subjects will be randomized to wear the investigational contact lens in 1 eye and the commercially available contact lens in the other eye. Subjects will be expected to attend 3 scheduled study visits: Day 1 Baseline/Dispense; Day 2 Follow-up; and Week 1 Follow-up/Exit. The expected duration of exposure to each of the study lenses for all randomized, completed subjects was approximately 7 days / 6 nights of wear.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Able to understand and sign an Institutional Review Board/Ethics Committee-approved Informed Consent form.
- •Successful wear of spherical soft contact lenses in both eyes during the past 3 months for a minimum of 5 days per week and in an extended wear modality a minimum of 1 night per week.
- •Best Corrected Visual Acuity (BCVA) of 20/25 or better in each eye.
- •Other protocol-specified inclusion criteria may apply.
Exclusion Criteria
- •Any condition, use of medications, or surgery that could contraindicate contact lens wear, as determined by the Investigator.
- •Current Biofinity© lens wearer.
- •Pregnant or breast-feeding.
- •Other protocol-specified exclusion criteria may apply.
Outcomes
Primary Outcomes
Visual Acuity (VA) With Study Lenses, Collected by Eye
Time Frame: Day 1 Dispense; Day 2 Follow-up (ideally within 4 hours of awakening); Week 1 Follow-up/Exit
Visual acuity (VA) was assessed for each eye individually with study lenses in place using a letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity. No formal hypothesis testing was planned.
Secondary Outcomes
No secondary outcomes reported