N/A
N=30
Comparing a Monthly Replacement Lens Versus a Daily Disposable Lens
Myopia
Bottom Line
View on ClinicalTrials.gov: NCT06046209 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Lens Handling at Insertion — 83; 93 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Control Lens (Device); Test Lens (Device)
- Age
- Pediatric, Adult · 17+ yrs
- Sex
- All
- Sponsor
- CooperVision, Inc.
- Primary completion
- Nov 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lens Handling at Insertion |
83; 93 | — |
Summary
The purpose of this study was to compare subjective ratings of lens handling at insertion for a monthly replacement lens versus a daily disposable lens in habitual soft lens wearers.
Eligibility Criteria
Inclusion Criteria
- Were 17 to 40 years of age and have full legal capacity to volunteer;
- Had read and signed an information consent letter;
- Were willing and able to follow instructions and maintain the appointment schedule;
- Were habitual daily wearers of spherical single vision soft contact lenses to correct for distance vision in each eye
- Were correctable to a visual acuity of 20/20 or better (in each eye) with sphero-cylindrical subjective refraction;
- Had an astigmatism of ≤ 0.75DC in subjective refraction;
- Could be fit with the study contact lenses with a power between -1.00 and -6.00DS; this translates to best corrected vision sphere refraction that vertexes to a CL power between -1.00 and -6.00 (inclusive) at screening visit.
- Demonstrated an acceptable fit with the study lenses.
Exclusion Criteria
- Had taken part in another clinical research study within the last 14 days;
- Were currently habitual wearers of toric, multifocal or monovision lenses.
- Had worn any rigid contact lenses in the past 6 months
- Were an extended lens wearer (i.e., sleeping with their lenses)
- Had a difference of ≥1.5 D in best vision sphere subjective refraction between eyes;
- Had amblyopia and/or distance strabismus/binocular vision problem;
- Had any known active ocular disease, allergies and/or infection;
- Had a systemic condition that in the opinion of the investigator may affect a study outcome variable;
- Were using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
- Had a known sensitivity to the diagnostic pharmaceuticals to be used in the study;
- Had undergone refractive error surgery or intraocular surgery;
- Were a member of CORE directly involved in the study.
Data sourced from ClinicalTrials.gov (NCT06046209). 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.