Performance Assessment of a Modified Daily Disposable Contact Lens
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Alcon Research
- Enrollment
- 62
- Locations
- 5
- Primary Endpoint
- High Contrast Distance Visual Acuity (logMAR)
Study Overview
Brief Summary
The purpose of this study is to compare visual acuity between two daily disposable contact lenses.
Detailed Description
The expected duration of subject participation in the study is approximately 2 weeks, with 3 scheduled visits.
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
- •Able to understand and sign an approved Informed Consent form;
- •Current wearer of commercial DAILIES TOTAL1 Contact Lenses in both eyes;
- •Other protocol-specified inclusion criteria may apply.
Exclusion Criteria
- •Any eye condition that contraindicates contact lens wear, as determined by the Investigator;
- •Any eye surgery that contraindicates contact lens wear, as determined by the Investigator;
- •Wears habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week)
- •Monocular (only one eye with functional vision);
- •Other protocol-specified exclusion criteria may apply.
Arms & Interventions
MDACL, then DACL
Modified delefilcon A contact lenses (MDACL) worn first, followed by delefilcon A contact lenses (DACL), as randomized. Each product worn bilaterally (in both eyes) for approximately 1 week in a daily disposable modality.
Intervention: Delefilcon A contact lenses (Device)
MDACL, then DACL
Modified delefilcon A contact lenses (MDACL) worn first, followed by delefilcon A contact lenses (DACL), as randomized. Each product worn bilaterally (in both eyes) for approximately 1 week in a daily disposable modality.
Intervention: Modified delefilcon A contact lenses (Device)
DACL, then MDACL
DACL worn first, followed by MDACL, as randomized. Each product worn bilaterally for approximately 1 week in a daily disposable modality.
Intervention: Modified delefilcon A contact lenses (Device)
DACL, then MDACL
DACL worn first, followed by MDACL, as randomized. Each product worn bilaterally for approximately 1 week in a daily disposable modality.
Intervention: Delefilcon A contact lenses (Device)
Outcomes
Primary Outcomes
High Contrast Distance Visual Acuity (logMAR)
Time Frame: Day 1 Dispense, Day 7 Follow-Up
Distance visual acuity (VA) testing was performed using letter charts. Each row of the chart contained 5 letters, with the letters on each row progressively smaller than the row above. The subject read the letters from larger to smaller. The test terminated when the subject either misidentified a majority of letters on 1 row or progressed to the smallest row of letters. Visual acuity scoring sheets were used to record the number of letters correctly read. LogMAR VA was calculated based on the total number of letters read incorrectly as follows: LogMAR Acuity = base reading + (0.02 x number of letters missed). A lower logMAR value indicates better VA.
Secondary Outcomes
No secondary outcomes reported