AstigmatismNCT07557030
Optimization for Toric Contact Lenses
A study testing Lens 1 ( stenfilcon A ) and Lens 2 ( comfilcon A ) in people with Astigmatism and Ametropia, run by CooperVision International Limited (CVIL) at 1 site in United States.
Trial summary
The aim of this study is to evaluate the agreement between subjective and objective toric lens prescriptions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Astigmatism, Ametropia
- What is being tested?
- Lens 1 ( stenfilcon A ) and Lens 2 ( comfilcon A )
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2026to 7 Jul 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- They are at least 18 years of age.
- They understand their rights as a research participant and are willing and able to sign a Statement of Informed Consent.
- They have spherical refractive error at the corneal plane between +4.00 to -7.00DS
- They have refractive astigmatism at the corneal plane of 0.75 to 2.25DC in one eye.
- They are able to achieve distance HCHL visual acuity of +0.10 logMAR or better in each eye
- They are a current soft contact lens wearer or have previous experience of successful soft contact lens wear in the past 3 years.
Who cannot join
- Is participating in any concurrent clinical or research trial.
- They have an ocular disorder which would normally contra-indicate contact lens wear.
- They have a systemic disorder which would normally contra-indicate contact lens wear.
- They are pseudophakic or aphakic.
- They have had corneal refractive surgery.
- They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
- Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to evaluate the agreement between subjective and objective toric lens prescriptions.
Read the detailed description
To evaluate agreement between subjective and objective optimized toric contact lens prescriptions.
- Conditions
- Astigmatism, Ametropia
- Being tested
- Lens 1 ( stenfilcon A ), Lens 2 ( comfilcon A )
- Medical subject headings
- Astigmatism, Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lens 1 ( stenfilcon A )Device
15 minutes of daily wear
Lens 2 ( comfilcon A )Device
15 minutes of daily wear
| Study group | Role | What they receive |
|---|---|---|
| Lens 1 ( stenfilcon A) | Experimental | All participants will be randomized to wear lens A Receives: Device: Lens 1 ( stenfilcon A ) |
| Lens 2 ( comfilcon A) | Experimental | All participants will be randomized to wear lens B Receives: Device: Lens 2 ( comfilcon A ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective assessment of optimization of Toric lenses
Proportion of eyes in which the optimized toric lens cylinder axis determined by the subjective method agrees with that determined by the objective method within ±10 degrees (measured at a single time point).
Measured: At the End of Baseline 15 minutes of daily wear
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start15 May 2026
- Primary completion7 Jul 2026
- Study completion7 Jul 2026
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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- CooperVision International Limited (CVIL)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Indiana University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07557030
- Sponsor's protocol ID
- CV-26-17
- Status last verified
- May 2026
- First submitted
- 23 Apr 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No