1 Week Crossover Dispensing Study Between Two Soft Contact Lenses

Last updated: February 13, 2025
Sponsor: CooperVision International Limited (CVIL)
Overall Status: Completed

Phase

N/A

Condition

Myopia

Treatment

Test Lenses

Control Lenses

Clinical Study ID

NCT06170658
CV-23-58
  • Ages 8-18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 andyounger); participant has read, signed and dated the study Information ConsentLetter (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 correctfor 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 aweek while in the study;

  8. 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

  9. Are correctable to a visual acuity of +0.10 logMAR or better (in each eye) withsphero-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 CLpower 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 lensesat the screening/fitting visit;

Exclusion

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 betweeneyes;

  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 studyoutcome variable;

  10. Are using any systemic or topical medications that in the opinion of theinvestigator 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.

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: Test Lenses
Phase:
Study Start date:
December 11, 2023
Estimated Completion Date:
August 21, 2024

Study 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.

Connect with a study center

  • University of Waterloo

    Waterloo, Ontario N2L 3G1
    Canada

    Site Not Available

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