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

NCT06873048 | Completed FDA Device

• 1 other identifier: CV-24-42
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Astigmatism; Myopia; Hyperopia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Control Contact Lens (stenfilcon A Sphere)

EXPERIMENTAL

All participants will wear Control Contact Lens for one week (Period 1).

Device: Control Contact Lens (stenfilcon A Sphere)

Test Contact Lens (stenfilcon A Toric)

EXPERIMENTAL

All participants will wear Test Contact Lens for one week (Period 2).

Device: Test Contact Lens (stenfilcon A Toric)

Interventions

Control Contact Lens (stenfilcon A Sphere) DEVICE

One week of wear

Control Contact Lens (stenfilcon A Sphere)

Test Contact Lens (stenfilcon A Toric) DEVICE

One week of wear

Test Contact Lens (stenfilcon A Toric)

Eligibility Criteria

• Age: 17 Years - 42 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• At least 17 years and no more than 42 years of age.
• Have read and signed the study consent form.
• Are willing and able to follow instructions and maintain the appointment schedule.
• Are habitual wearer of spherical soft contact lenses (not toric or multifocal design), any brand and any replacement frequency.
• 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.
• 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.
• Are non-presbyopic i.e. no requirement for a reading addition for routine daily tasks (self report).
• Have astigmatism of either -0.50, -0.75, -1.00 or -1.25 DC in each eye by subjective sphero-cylindrical refraction.
• Achieves at least 0.10 LogMAR in each eye by subjective sphero-cylindrical refraction.
• Can be fit with available study contact lens powers of between +6.00 to -10.00 DS.
• Demonstrate an acceptable fit with the study contact lenses.

You may not qualify if:

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

Sponsors & Collaborators

• CooperVision International Limited (CVIL): lead
• Centre for Ocular Research & Education, Canada: collaborator

Study Sites (1)

School of Optometry & Vision Science

Waterloo, Ontario, N2L 3G1, Canada

Location

MeSH Terms

Conditions

Astigmatism; Myopia; Hyperopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Lyndon Jones, PhD,FCOptom

  Centre for Ocular Research and Education

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: March 12, 2025
• Study Start: February 26, 2025
• Primary Completion: July 11, 2025
• Study Completion: July 11, 2025
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

CA (1)