N/A
N=40
Clinical Evaluation of Two Frequent Replacement Soft Spherical Contact Lenses
Myopia · Hyperopia
Bottom Line
View on ClinicalTrials.gov: NCT05656885 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcome: Primary: Lens Fit Acceptance Rating — 3.28; 3.48 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Lens A (Device); Lens B (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- CooperVision, Inc.
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lens Fit Acceptance Rating |
3.28; 3.48 | — |
Summary
This was a single-blind (participant masked), interventional, prospective, direct refit, bilateral wear short-term fitting study.
Eligibility Criteria
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 at least 8 hours a day, 5 days a week.
- Is willing and able to follow instructions and maintain the appointment schedule.
- Habitual soft contact lens wearers who currently wear sphere contact lenses, or use spectacles for all distances vision correction, for the past 3 months minimum.
- Has refractive astigmatism no higher than -0.75DC.
- Can be fit and achieve binocular distance vision of at least 20/30 Snellen (or +0.20 logMAR) which participants also deem to be 'acceptable', with the available study lens parameters (powers +8.00 to -12.00DS)
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.
Data sourced from ClinicalTrials.gov (NCT05656885). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.