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RecruitingNCT07829419Updated Nov 4, 2026

Evaluation of Two Monthly Silicone Hydrogel Multifocal Toric in Soft Contact Lens Wearers

An interventional study of Lens A ( comfilcon A) and Lens B ( lehfilcon A) in Astigmatism and Myopia, sponsored by CooperVision International Limited (CVIL). Recruiting at 3 sites in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.

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

Updated Nov 4, 2026Now RecruitingSite recruiting status changed+1 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Study summary

To compare the performance of two leading soft multifocal Toric contact lenses.

Read the detailed description

Prospective, randomized, subject-masked, bilateral crossover dispensing study.

02

Conditions studied

  • Astigmatism
  • Myopia
03

In context

Astigmatism

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

This study's planned enrollment of 60 is close to 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
40 Years and older
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

A person is eligible for inclusion in the study if they are:

  1. Participants at least 40 years of age.
  2. Participants requiring lens powers within the range available for the study lenses.
  3. Participants with a spherical refractive error at the corneal plane of plano to -6.00.
  4. Participants with a minimum reading add of +0.75DS (based on their spectacle refraction at screening). At least 12 participants will be enrolled per add group: low (+0.75 to +1.25D), medium (+1.50 to +1.75D), and high (+2.00 to +2.50).
  5. Participants with refractive astigmatism at the corneal plane of 0.75 to 2.00DC.
  6. Best spectacle corrected visual acuity greater than or equal to 20/25 (less than or equal to LogMAR 0.1).
  7. Habitually using soft contact lenses (multifocal soft contact lenses, sphere or toric lenses for monovision, or sphere or toric lenses for distance vision correction and spectacles for near vision correction) and have worn lenses at least 3 days a week for at least the past six months.
  8. Anticipating being able to wear contact lenses for at least 8 hours a day, 5 days a week.
  9. Willing and able to follow instructions and maintain the appointment schedule.

Exclusion criteria

Exclusion Criteria:

  1. Anterior segment infection, inflammation or abnormality that would contraindicate contact lens wear.
  2. Any active anterior segment ocular disease that would contraindicate contact lens wear.
  3. The use of systemic or ocular medications that would contraindicate contact lens wear.
  4. History of herpetic keratitis.
  5. History of refractive surgery or irregular cornea.
  6. Slit lamp findings that are more serious than grade 1 (see ISO 11980 scale).
  7. Inactive (i.e. ghost) vessels greater than 1 mm of penetration into the cornea.
  8. Participation of the participant in a contact lens or contact lens care product clinical trial within the previous 90 days if involving orthokeratology, 30 days if involving extended wear, rigid gas permeable corneal and scleral lenses, or 15 days if involving daily disposable, daily wear soft lenses.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Lens A then Lens B

    Participants will wear the Test Lenses in both eyes for one month and then cross over to the Control Lenses in both eyes for one month.

    Device: Lens A ( comfilcon A)

  • Experimental
    Lens B and then Lens A

    Participants will wear the Control Lenses in both eyes for one month and then cross over to the Test Lenses in both eyes for one month.

    Device: Lens B ( lehfilcon A)

Interventions

  • DeviceLens A ( comfilcon A)

    Daily disposable, soft contact lenses worn for one month

  • DeviceLens B ( lehfilcon A)

    Daily disposable, soft contact lenses worn for one month

06

What researchers measure

Primary outcomes

  1. Ease of handling

    Ease of handling for lens removal (0-100)

    Time frame: 1 month

07

Study locations

1 of 3 sites recruiting
  • Sacco Eye Group
    New York, New York 13850, United States
    Not yet recruiting
  • ProCare Vision Center
    Granville, Ohio 43023, United States
    Not yet recruiting
    • Katherine Bickle · Contactkbickle12@yahoo.com · 7405873937
    • Katherine Bickle, OD · Principal investigator
  • Drs. Mcintyre Garza Avila & Jurica
    Corpus Christi, Texas 78411, United States
    Recruiting
    • Alissa Shawver · Contactalissa@cccontacts.com · 3619940310
    • David Browning, OD · Principal investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar 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

Started Nov 2026 (actual). Primary completion is estimated for Sep 2027, 10 months after the start.

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 planned 10 months is above that.

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

Start moved once since we started tracking on Sep 25, 2026: Sep 2026 → Nov 2026, on Nov 4, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

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

Registered
Sep 15, 2026
First posted
Sep 21, 2026
StartActual
Nov 2, 2026was Sep 2026
Primary completionEst.
Sep 2027
CompletionEst.
Sep 2027
Last update
Nov 4, 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.
Status
Not yet recruiting→Recruiting
changed Nov 4, 2026
Sites
3 sites changed recruiting status (2 now not yet recruiting, 1 now recruiting)
Show 3 sites
  • Sacco Eye Group · New York, United Statesno status→Not yet recruiting
  • ProCare Vision Center · Granville, United Statesno status→Not yet recruiting
  • Drs. Mcintyre Garza Avila & Jurica · Corpus Christi, United Statesno status→Recruiting
Nov 4, 2026
Start date
Sep 2026→Nov 2, 2026 (actual)
Nov 4, 2026
Show all 1 update
  1. Nov 4, 2026
    Not yet recruiting→Recruiting
    3 sites changed recruiting status (2 now not yet recruiting, 1 now recruiting)
    Show 3 sites
    • Sacco Eye Group · New York, United Statesno status→Not yet recruiting
    • ProCare Vision Center · Granville, United Statesno status→Not yet recruiting
    • Drs. Mcintyre Garza Avila & Jurica · Corpus Christi, United Statesno status→Recruiting
    Start date Sep 2026→Nov 2, 2026 (now actual)

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07829419
Lead sponsor
CooperVision International Limited (CVIL)
Responsible party
Sponsor
First posted
Sep 21, 2026
Start date
Nov 2, 2026
Primary completion
Sep 2027 (estimated)
Completion
Sep 2027 (estimated)
Last update
Nov 4, 2026

Study contacts

Liandra Jung
Contact
liandra.jung@coopervision.com
+19253948002

Oversight

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

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