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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization for Toric Contact Lenses
- ClinicalTrials.gov ID
- NCT07557030
- Acronym / sponsor ID
- CV-26-17
- Conditions
- Astigmatism, Ametropia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- CooperVision International Limited (CVIL)Industry (pharma, biotech, devices)
- Collaborators
- Indiana University
- Study start
- 15 May 2026 (actual)
- Primary completion
- 7 Jul 2026 (actual)
- Study completion
- 7 Jul 2026 (actual)
- First posted
- 29 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate the agreement between subjective and objective toric lens prescriptions.
Detailed description
To evaluate agreement between subjective and objective optimized toric contact lens prescriptions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lens 1 ( stenfilcon A) | Experimental | Device: Lens 1 ( stenfilcon A )All participants will be randomized to wear lens A |
| Lens 2 ( comfilcon A) | Experimental | Device: Lens 2 ( comfilcon A )All participants will be randomized to wear lens B |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lens 1 ( stenfilcon A )15 minutes of daily wear | Device | Lens 1 ( stenfilcon A) |
| Lens 2 ( comfilcon A )15 minutes of daily wear | Device | Lens 2 ( comfilcon A) |
Primary outcome
Subjective assessment of optimization of Toric lenses
Time frame: At the End of Baseline 15 minutes of daily wear
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective assessment of optimization of Toric lenses (time frame: At the End of Baseline 15 minutes of daily wear). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.