AstigmatismNCT07829419
Evaluation of Two Monthly Silicone Hydrogel Multifocal Toric in Soft Contact Lens Wearers
A study testing Lens A ( comfilcon A) and Lens B ( lehfilcon A) in people with Astigmatism and Myopia, run by CooperVision International Limited (CVIL) at 3 sites in United States.
Trial summary
To compare the performance of two leading soft multifocal Toric contact lenses. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Astigmatism, Myopia
- What is being tested?
- Lens A ( comfilcon A) and Lens B ( lehfilcon A)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2026to Sep 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A person is eligible for inclusion in the study if they are:
- Participants at least 40 years of age.
- Participants requiring lens powers within the range available for the study lenses.
- Participants with a spherical refractive error at the corneal plane of plano to -6.00.
- 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).
- Participants with refractive astigmatism at the corneal plane of 0.75 to 2.00DC.
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- Best spectacle corrected visual acuity greater than or equal to 20/25 (less than or equal to LogMAR 0.1).
- 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.
- Anticipating being able to wear contact lenses for at least 8 hours a day, 5 days a week.
- Willing and able to follow instructions and maintain the appointment schedule.
Who cannot join
- Anterior segment infection, inflammation or abnormality that would contraindicate contact lens wear.
- Any active anterior segment ocular disease that would contraindicate contact lens wear.
- The use of systemic or ocular medications that would contraindicate contact lens wear.
- History of herpetic keratitis.
- History of refractive surgery or irregular cornea.
- Slit lamp findings that are more serious than grade 1 (see ISO 11980 scale).
- Inactive (i.e. ghost) vessels greater than 1 mm of penetration into the cornea.
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
Drs. Mcintyre Garza Avila & Jurica
Corpus Christi, Texas, 78411
Alissa Shawver, 3619940310, alissa@cccontacts.com
David Browning, OD
ProCare Vision Center
Granville, Ohio, 43023
Katherine Bickle, 7405873937, kbickle12@yahoo.com
Katherine Bickle, OD
Sacco Eye Group
New York, New York, 13850
Staci Sacco, 6077981987, researchcoordinator@saccoresearch.com
Andrew Sacco, OD
About this study
Official title: Clinical Performance Evaluation of Two Monthly Replacement Silicone Hydrogel Multifocal Toric Lens Designs in Habitual Soft Contact Lens Wearers
To compare the performance of two leading soft multifocal Toric contact lenses.
Read the detailed description
Prospective, randomized, subject-masked, bilateral crossover dispensing study.
- Conditions
- Astigmatism, Myopia
- Being tested
- Lens A ( comfilcon A), Lens B ( lehfilcon A)
- Medical subject headings
- Astigmatism, Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lens A ( comfilcon A)Device
Daily disposable, soft contact lenses worn for one month
Lens B ( lehfilcon A)Device
Daily disposable, soft contact lenses worn for one month
| Study group | Role | What they receive |
|---|---|---|
| Lens A then Lens B | Experimental | 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. Receives: Device: Lens A ( comfilcon A) |
| Lens B and then Lens A | Experimental | 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. Receives: Device: Lens B ( lehfilcon A) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ease of handling
Ease of handling for lens removal (0-100)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AstigmatismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CooperVision International Limited (CVIL)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07829419
- Sponsor's protocol ID
- MKTG-26-24
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No