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

Last updated: March 7, 2025
Sponsor: CooperVision International Limited (CVIL)
Overall Status: Active - Recruiting

Phase

N/A

Condition

Eye Disorders/infections

Eye Disease

Astigmatism

Treatment

Test Contact Lens (stenfilcon A Toric)

Control Contact Lens (stenfilcon A Sphere)

Clinical Study ID

NCT06873048
CV-24-42
  • Ages 17-42
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 multifocaldesign), any brand and any replacement frequency.

  5. Are willing to wear the study contact lenses for 6 days a week while in this studyand 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 thatallows them to respond to a short online questionnaire every 3 hours on days 1, 7and 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 dailytasks (self report).

  8. Have astigmatism of either -0.50, -0.75, -1.00 or -1.25 DC in each eye by subjectivesphero-cylindrical refraction.

  9. Achieves at least 0.10 LogMAR in each eye by subjective sphero-cylindricalrefraction.

  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

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 thatcontraindicate contact lens wear.

  6. Have a systemic condition that in the opinion of the investigator may affect a studyoutcome variable or contraindicate wearing soft contact lenses.

  7. Are using any systemic or topical medications that in the opinion of theinvestigator may affect a study outcome variable or contraindicate wearing softcontact 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 inthis study.

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: Test Contact Lens (stenfilcon A Toric)
Phase:
Study Start date:
February 26, 2025
Estimated Completion Date:
August 15, 2025

Study 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.

Connect with a study center

  • School of Optometry & Vision Science

    Waterloo, Ontario N2L 3G1
    Canada

    Active - Recruiting

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