Clinical trial NCT06170658: 1 Week Crossover Dispensing Study Between Two Soft Contact Lenses
Official title: 1 Week Crossover Dispensing Study: Buttermere Versus MiSight 1 Day Soft Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2023-12-14
Enrollment: 30
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Are 8 to 18 years of age inclusive and have full legal capacity to volunteer;
2. 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);
3. Are willing and able to follow instructions and maintain the appointment schedule;
4. Are habitual daily wearers of spherical single vision soft contact lenses to correct for distance vision in each eye;
5. Currently wears spherical soft contact lenses or myopia control soft lenses;
6. Have a pair of wearable back-up spectacles;
7. Are willing and able to wear contact lenses for at least 10 hours a day, 6 days a week while in the study;
8. 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
9. Are correctable to a visual acuity of +0.10 logMAR or better (in each eye) with sphero-cylindrical subjective refraction;
10. Have clear corneas with no corneal scars or any active ocular disease;
11. 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.
12. Demonstrate an acceptable fit with the study lenses.
13. Demonstrate that they can safely and independently insert and remove contact lenses at the screening/fitting visit;

Exclusion Criteria:

1. Have taken part in another clinical research study within the last 14 days;
2. Are currently habitual wearers of toric lenses.
3. Have worn any rigid contact lenses or ortho-keratology lenses in the past 30 days
4. Are an extended lens wearer (i.e., sleeping with their lenses)
5. Are on ongoing atropine treatment for myopia control
6. Have a difference of \> 1.0 D in best vision sphere subjective refraction between eyes;
7. Have amblyopia and/or strabismus/binocular vision problem
8. Have any known active ocular disease, allergies and/or infection;
9. Have a systemic condition that in the opinion of the investigator may affect a study outcome variable;
10. Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
11. Have a known sensitivity to the diagnostic pharmaceuticals to be used in the study;
12. Have undergone refractive error surgery or intraocular surgery;
13. Are a member of CORE directly involved in the study.

Primary outcomes:
measure: High contrast, binocular, distance visual acuity
timeFrame: 7 days
Secondary outcomes:
measure: Subjective Vision Quality
timeFrame: 7 days
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: University of Waterloo
state: Ontario
Study officials:
affiliation: University of Waterloo
name: Lyndon Jones, PhD,FCOptom
role: PRINCIPAL_INVESTIGATOR
References: