NCT06400914CompletedNot Applicable
Clinical Evaluation of Biomedics Monthly Sphere and Avaira Vitality Sphere
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- CooperVision, Inc.
- Enrollment
- 44
- Locations
- 2
- Primary Endpoint
- Lens Fit Acceptance Ratings
Study Overview
Brief Summary
The aim of this study is to compare the short-term clinical performance of two sphere contact lenses.
Detailed Description
The aim of this study is to evaluate the short-term clinical performance of two different sphere contact lenses 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 +6.00 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.
Outcomes
Primary Outcomes
Lens Fit Acceptance Ratings
Time Frame: At the end of 15 Minutes of wear
Overall lens fit acceptance was measured on a scale from 0-4 (0=Should not be worn and 4= Perfect)
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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