1 Week Crossover Dispensing Study Between Two Soft Contact Lenses

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

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.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: Test Lenses (stenfilcon A); Device: Control Lenses (omafilcon A)

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Waterloo, Ontario, Canada, N2L 3G1
      • University of Waterloo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test Lenses, Then Control Lenses; Participants will wear the Test Lenses in both eyes for one week and then cross over to the Control Lenses in both eyes for one week.	Device: Test Lenses (stenfilcon A); Daily disposable, silicone hydrogel investigational lenses for one week; Device: Control Lenses (omafilcon A); Daily disposable, hydrogel commercially available lenses for one week
Experimental: Control Lenses, Then Test Lenses; Participants will wear the Control Lenses in both eyes for one week and then cross over to the Test Lenses in both eyes for one week.	Device: Test Lenses (stenfilcon A); Daily disposable, silicone hydrogel investigational lenses for one week; Device: Control Lenses (omafilcon A); Daily disposable, hydrogel commercially available lenses for one week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Vision Quality	Subjective vision quality on 0-100 scale, integer steps (0 = Very poor; 100 = Excellent vision, totally sharp)	7 days

Collaborators and Investigators

• Sponsor: CooperVision, Inc.
• Investigators: Principal Investigator: Lyndon Jones, PhD,FCOptom, University of Waterloo

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2023
• Primary Completion (Actual): August 21, 2024
• Study Completion (Actual): August 21, 2024

Study Registration Dates

• First Submitted: December 6, 2023
• First Submitted That Met QC Criteria: December 6, 2023
• First Posted (Actual): December 14, 2023

Study Record Updates

• Last Update Posted (Actual): August 6, 2025
• Last Update Submitted That Met QC Criteria: August 1, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: CV-23-58

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes