Phase
Condition
Myopia
Treatment
Test Lenses
Control Lenses
Clinical Study ID
Ages 8-18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 andyounger); participant has read, signed and dated the study Information ConsentLetter (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 correctfor 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 aweek while in the study;
Are myopic with subjective refraction: -0.75D to -7.00D spherical, with anastigmatism ≤ -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) withsphero-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 CLpower 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 lensesat the screening/fitting visit;
Exclusion
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 betweeneyes;
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 studyoutcome variable;
Are using any systemic or topical medications that in the opinion of theinvestigator 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 Description
Connect with a study center
University of Waterloo
Waterloo, Ontario N2L 3G1
CanadaSite Not Available
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