CompletedNot Applicable

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

Canada32 participantsStarted 2025-02-26

Plain-language summary

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

Age range17 Years – 42 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.

Contact Lens Comfort

Timeframe: Day 1 (day after dispense), Day 7 and Day 13 at 12 hours contact lens wear

NCT IDNCT06873048

SponsorCooperVision International Limited (CVIL)

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-07-11

Who can participate

Age range17 Years – 42 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.