1 Week Crossover Dispensing Study Between Two Soft Contact Lenses
Not Applicable
Completed
- Conditions
- Myopia
- Registration Number
- NCT06170658
- Lead Sponsor
- CooperVision International Limited (CVIL)
- Brief Summary
The objective of this investigation is to compare the visual clinical performance of a silicone hydrogel daily disposable investigational contact lenses to a hydrogel daily disposable commercially available contact lenses.
- Detailed Description
This is a prospective, bilateral, double masked (participant and investigator), randomized, cross-over dispensing study with 1 week wearing period in each arm by comparing visual acuity and subjective vision quality.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- Are 8 to 18 years of age inclusive and have full legal capacity to volunteer;
- Have read and signed and dated the Parental Permission Form (for those aged 16 and younger); participant has read, signed and dated the study Information Consent Letter (if aged 17 or 18 years) or Assent (aged 16 and younger);
- Are willing and able to follow instructions and maintain the appointment schedule;
- Are habitual daily wearers of spherical single vision soft contact lenses to correct for distance vision in each eye;
- Currently wears spherical soft contact lenses or myopia control soft lenses;
- Have a pair of wearable back-up spectacles;
- Are willing and able to wear contact lenses for at least 10 hours a day, 6 days a week while in the study;
- Are myopic with subjective refraction: -0.75D to -7.00D spherical, with an astigmatism ≤ -0.75D in each eye with maximum spherical equivalent anisometropia of 1.00D
- Are correctable to a visual acuity of +0.10 logMAR or better (in each eye) with sphero-cylindrical subjective refraction;
- Have clear corneas with no corneal scars or any active ocular disease;
- Can be fit with the study contact lenses with a power between -0.75 and -7.00 DS; this translates to best corrected vision sphere refraction that vertexes to a CL power between -0.75 and -7.00 (inclusive) at screening visit.
- Demonstrate an acceptable fit with the study lenses.
- Demonstrate that they can safely and independently insert and remove contact lenses at the screening/fitting visit;
Exclusion Criteria
- Have taken part in another clinical research study within the last 14 days;
- Are currently habitual wearers of toric lenses.
- Have worn any rigid contact lenses or ortho-keratology lenses in the past 30 days
- Are an extended lens wearer (i.e., sleeping with their lenses)
- Are on ongoing atropine treatment for myopia control
- Have a difference of > 1.0 D in best vision sphere subjective refraction between eyes;
- Have amblyopia and/or strabismus/binocular vision problem
- Have any known active ocular disease, allergies and/or infection;
- Have a systemic condition that in the opinion of the investigator may affect a study outcome variable;
- Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
- Have a known sensitivity to the diagnostic pharmaceuticals to be used in the study;
- Have undergone refractive error surgery or intraocular surgery;
- Are a member of CORE directly involved in the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method High contrast, binocular, distance visual acuity 7 days Distance visual acuity (LogMAR) will be measured using high and low contrast computer-generated acuity charts.
- Secondary Outcome Measures
Name Time Method Subjective Vision Quality 7 days Subjective vision quality on 0-100 scale, integer steps (0 = Very poor; 100 = Excellent vision, totally sharp)
Trial Locations
- Locations (1)
University of Waterloo
🇨🇦Waterloo, Ontario, Canada
University of Waterloo🇨🇦Waterloo, Ontario, Canada