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CompletedNCT06873048Updated Apr 8, 2026

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

An interventional study of Control Contact Lens (stenfilcon A Sphere) and Test Contact Lens (stenfilcon A Toric) in Astigmatism, Myopia and Hyperopia, sponsored by CooperVision International Limited (CVIL). Completed at 1 site in Canada. Open to participants aged 17 Years to 42 Years. Per ClinicalTrials.gov, last updated 2026-04-08.

Sponsored by CooperVision International Limited (CVIL) (part of CooperCompanies) · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Jul 2025, 1 year 4 months ago, and no results have been posted to the registry.
Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Non-randomized
Ages
17 Years to 42 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Astigmatism
  • Myopia
  • Hyperopia
03

In context

Astigmatism

417 studies on the registry are indexed under Astigmatism; 50 are open to participants now.

This study's enrollment of 32 is below the median of 55 across 325 interventional studies indexed under Astigmatism.

Browse Astigmatism studies →

Lead sponsor

CooperVision International Limited (CVIL) is the lead sponsor of 138 studies on the registry; 6 are open to participants now.

Of its 74 completed or terminated interventional studies of FDA-regulated products, 66 (89%) have results posted.

Browse CooperVision International Limited (CVIL) studies →All CooperCompanies studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
17 Years to 42 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
32 participants (actual)

Study arms

  • 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)

  • 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)

Interventions

  • DeviceControl Contact Lens (stenfilcon A Sphere)

    One week of wear

  • DeviceTest Contact Lens (stenfilcon A Toric)

    One week of wear

06

What researchers measure

Primary outcomes

  1. Contact Lens Comfort

    Contact lens comfort will be measured on the scale of 0-100 where, (0=worst and 100=best)

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

07

Study locations

1 site
  • School of Optometry & Vision Science
    Waterloo, Ontario N2L 3G1, Canada
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2025 to primary completion in Jul 2025, 4 months.

Of 106 industry-sponsored interventional studies with no phase under Astigmatism, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 19. This study's 4 months is below that.

Counting every sponsor, half of 183 studies reached it within 12 months; a quarter within 4 and three quarters within 26.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 7, 2025
First posted
Mar 12, 2025
StartActual
Feb 26, 2025
Primary completionActual
Jul 11, 2025
CompletionActual
Jul 11, 2025
Last update
Apr 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06873048
Lead sponsor
CooperVision International Limited (CVIL)
Collaborators
Centre for Ocular Research & Education, Canada
Responsible party
Sponsor
First posted
Mar 12, 2025
Start date
Feb 26, 2025
Primary completion
Jul 11, 2025
Completion
Jul 11, 2025
Last update
Apr 8, 2026

Study contacts

Lyndon Jones, PhD,FCOptom
principal investigator · Centre for Ocular Research and Education

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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