1 Week Crossover Dispensing Study Between Two Soft Contact Lenses

Myopia Clinical Trial

Official title:

1 Week Crossover Dispensing Study: Buttermere Versus MiSight 1 Day Soft Contact Lenses

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06170658
• Other study ID #: CV-23-58
• Status: Recruiting
• Phase: N/A
• Start date: December 11, 2023
• Est. completion date: July 31, 2024

Study information

• Verified date: November 2023
• Source: Coopervision, Inc.
• Contact: Cameron Postnikoff
• Phone: 9257306734
• Email: cpostnikoff[@]coopervision.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 31, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Test Lenses
Daily disposable, silicone hydrogel investigational lenses for one week
• Control Lenses
Daily disposable, hydrogel commercially available lenses for one week

Locations

Country	Name	City	State
Canada	University of Waterloo	Waterloo	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Coopervision, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	High contrast, binocular, distance visual acuity	Distance visual acuity (LogMAR) will be measured using high and low contrast computer-generated acuity charts.	7 days
Secondary	Subjective Vision Quality	Subjective vision quality on 0-100 scale, integer steps (0 = Very poor; 100 = Excellent vision, totally sharp)	7 days