Short-term Study of Two Soft Contact Lenses in Wearers With Low Astigmatism

Short-term Study of Myday Sphere and Myday Toric Lenses in Existing Spherical Soft Contact Lenses Wearers With Low Astigmatism (Pacific)

The primary objective of the study is to evaluate and compare the performance of two soft contact lens.

Study Overview

• Status: Completed
• Conditions: Astigmatism; Myopia; Hyperopia
• Intervention / Treatment: Device: Control Contact Lens (stenfilcon A Sphere); Device: Test Contact Lens (stenfilcon A Toric)

Detailed Description

The primary objective of the study is to evaluate and compare the performance of two different soft contact lens in existing spherical soft contact lens (CL) wearers with low levels of refractive astigmatism over a 2-week wear period.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Waterloo, Ontario, Canada, N2L 3G1
      • School of Optometry & Vision Science

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. At least 17 years and no more than 42 years of age.
2. Have read and signed the study consent form.
3. Are willing and able to follow instructions and maintain the appointment schedule.
4. Are habitual wearer of spherical soft contact lenses (not toric or multifocal design), any brand and any replacement frequency.
5. Are willing to wear the study contact lenses for 6 days a week while in this study and on three days (day 1, Day 7 and Day 13) for at least 12 hours.
6. Are willing to provide a contact email and telephone number and to use a device that allows them to respond to a short online questionnaire every 3 hours on days 1, 7 and 13 of each lens arm, while wearing one of the 2 study lenses.
7. Are non-presbyopic i.e. no requirement for a reading addition for routine daily tasks (self report).
8. Have astigmatism of either -0.50, -0.75, -1.00 or -1.25 DC in each eye by subjective sphero-cylindrical refraction.
9. Achieves at least 0.10 LogMAR in each eye by subjective sphero-cylindrical refraction.
10. Can be fit with available study contact lens powers of between +6.00 to -10.00 DS.
11. Demonstrate an acceptable fit with the study contact lenses.

Exclusion Criteria:

1. Are participating in any concurrent clinical interventional study.
2. Have worn rigid contact lenses in the last 3 months.
3. Have worn soft toric contact lenses in the past 3 months.
4. Have any known active ocular disease or allergies and/or infection.
5. Have clinically significant biomicroscopy findings or have an ocular condition that contraindicate contact lens wear.
6. Have a systemic condition that in the opinion of the investigator may affect a study outcome variable or contraindicate wearing soft contact lenses.
7. Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable or contraindicate wearing soft contact lenses.
8. Have known sensitivity to the diagnostic sodium fluorescein to be used in the study.
9. Have undergone refractive error surgery or intraocular surgery.
10. Are an employee of the Centre for Ocular Research & Education directly involved in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Control Contact Lens (stenfilcon A Sphere); All participants will wear Control Contact Lens for one week (Period 1).	Device: Control Contact Lens (stenfilcon A Sphere); One week of wear
Experimental: Test Contact Lens (stenfilcon A Toric); All participants will wear Test Contact Lens for one week (Period 2).	Device: Test Contact Lens (stenfilcon A Toric); One week of wear

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contact Lens Comfort	Contact lens comfort will be measured on the scale of 0-100 where, (0=worst and 100=best)	Day 1 (day after dispense), Day 7 and Day 13 at 12 hours contact lens wear

Collaborators and Investigators

• Sponsor: CooperVision International Limited (CVIL)
• Collaborators: Centre for Ocular Research & Education, Canada
• Investigators: Principal Investigator: Lyndon Jones, PhD,FCOptom, Centre for Ocular Research and Education

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2025
• Primary Completion (Actual): July 11, 2025
• Study Completion (Actual): July 11, 2025

Study Registration Dates

• First Submitted: March 7, 2025
• First Submitted That Met QC Criteria: March 7, 2025
• First Posted (Actual): March 12, 2025

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 6, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia; Astigmatism; Hyperopia
• Other Study ID Numbers: CV-24-42

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