Clinical Evaluation of Two Daily Disposable Lenses in Sphere Design
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Coopervision, Inc.
- Enrollment
- 41
- Locations
- 1
- Primary Endpoint
- Lens Fit Acceptance
Study Overview
Brief Summary
This was a single-blind, interventional, prospective, direct refit, bilateral wear, fixed-sequence crossover study.
Detailed Description
The aim of this study was to evaluate the visual performance and subjective experiences of daily disposable hydrogel lens (DDH) when compared to daily disposable silicone hydrogel lens (DDSH) after 15 minutes of daily wear each.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Is at least 18 years of age and has full legal capacity to volunteer.
- •Has read and signed an information consent letter.
- •Self-reports having a full eye examination in the previous two years.
- •Anticipates being able to wear the study lenses for the required time of the study.
- •Is willing and able to follow instructions and maintain the appointment schedule.
- •Has refractive astigmatism no higher than -0.75 DC.
- •Can be fit with the available lens parameters (sphere +8.00 to -10.00D).
- •Can achieve binocular distance vision of at least 20/30 Snellen (logMAR 0.18) with the study contact lenses.
Exclusion Criteria
- •Is participating in any concurrent clinical or research study.
- •Has any known active ocular disease and/or infection that contraindicates contact lens wear.
- •Has a systemic condition that in the opinion of the investigator may affect a study outcome variable.
- •Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable.
- •Has known sensitivity to the diagnostic sodium fluorescein used in the study.
- •Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment.
- •Has undergone refractive error surgery or intraocular surgery.
Arms & Interventions
Lens A
All participants wore Lens A for 15 minutes (Period 1)
Intervention: Lens A (Device)
Lens B
All participants wore Lens B for 15 minutes (Period 2)
Intervention: Lens B (Device)
Outcomes
Primary Outcomes
Lens Fit Acceptance
Time Frame: 15 minutes
Measured on a scale of 0-4 (0 = Should not be worn, 1 = Borderline but unacceptable, 2 = Min. acceptable, early review, 3 = Not perfect but OK to dispense, 4 = Perfect) as assessed by an investigator.
Secondary Outcomes
No secondary outcomes reported