AstigmatismNCT07898995
Clinical Performance and Outcomes After Toric Lens Transition
A study testing Fanfilcon A Toric Contact Lens in people with Astigmatism, run by CooperVision International Limited (CVIL) at 1 site in United States.
Trial summary
To evaluate subjective and clinical outcomes after transitioning from one toric soft contact lens to another over a one-month period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Astigmatism
- What is being tested?
- Fanfilcon A Toric Contact Lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Participants with eyes appropriate for the study being conducted.
- 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.
- Current habitual wearer of Biofinity toric soft contact lenses with contact lens power ranging from +8.00 to -10.00 DS and -0.75 to 2.25 DC.
- Anisometropia no greater than 1.50D, based on contact lens power spherical equivalent.
- Can achieve visual acuity of at least 0.1 logMAR (20/25) in each eye with contact lenses.
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- Able to wear the study contact lenses for 6 days a week, minimum 8 hours a day.
- Can be fitted with the study contact lenses (Avaira Vitality® toric).
- They agree not to participate in any other clinical research study while enrolled in this study.
Who cannot join
- Anterior segment infection, inflammation or abnormality
- 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 (ISO scale).
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- Inactive (i.e. ghost) vessels greater than 1 mm of penetration into the cornea
- They have corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
- They have participated in a contact lens or lens care product trial in past 30 days
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Indiana University
Bloomington, Indiana, 47405
Emily Koontz, 812-856-0108, emrwatki@iu.edu
Pete Kollbaum, OD, PhD
About this study
Official title: Clinical Performance and Patient Outcomes When Transitioning From Comfilcon A Toric to Fanfilcon A Toric Lenses
To evaluate subjective and clinical outcomes after transitioning from one toric soft contact lens to another over a one-month period.
Read the detailed description
Subject-masked, direct refit, daily wear, 1-month study
- Conditions
- Astigmatism
- Being tested
- Fanfilcon A Toric Contact Lens
- Keywords
- myopia
- Medical subject headings
- Astigmatism, Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fanfilcon A Toric Contact LensDevice
Participants are refit from their habitual toric soft contact lenses to fanfilcon A toric contact lenses and wear the lenses for approximately one month according to the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Refit to Fanfilcon A Toric Contact Lens | Experimental | Habitual wears of Confilcon A soft toric contact lenses Refitted to Fanfilcon A toric contact lenses and followed for one month. Receives: Device: Fanfilcon A Toric Contact Lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Comfort
Subjective comfort on insertion (0-100 Visual Analogue Scale)
Measured: Baseline, 1 week, and 1 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionFeb 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 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
- NCT07898995
- Sponsor's protocol ID
- MKTG-26-41
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 5 Nov 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 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance and Patient Outcomes When Transitioning From Comfilcon A Toric to Fanfilcon A Toric Lenses
- ClinicalTrials.gov ID
- NCT07898995
- Acronym / sponsor ID
- MKTG-26-41
- Conditions
- Astigmatism
- Keywords
- myopia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- CooperVision International Limited (CVIL)Industry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 27 Oct 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.
To evaluate subjective and clinical outcomes after transitioning from one toric soft contact lens to another over a one-month period.
Detailed description
Subject-masked, direct refit, daily wear, 1-month study
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Refit to Fanfilcon A Toric Contact Lens | Experimental | Device: Fanfilcon A Toric Contact LensHabitual wears of Confilcon A soft toric contact lenses Refitted to Fanfilcon A toric contact lenses and followed for one month. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Participants with eyes appropriate for the study being conducted.
- 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.
- Current habitual wearer of Biofinity toric soft contact lenses with contact lens power ranging from +8.00 to -10.00 DS and -0.75 to 2.25 DC.
- Anisometropia no greater than 1.50D, based on contact lens power spherical equivalent.
Key exclusion criteria (9 listed)
- Anterior segment infection, inflammation or abnormality
- 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
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 |
|---|---|---|
| Fanfilcon A Toric Contact LensParticipants are refit from their habitual toric soft contact lenses to fanfilcon A toric contact lenses and wear the lenses for approximately one month according to the study protocol. | Device | Refit to Fanfilcon A Toric Contact Lens |
Primary outcome
Subjective Comfort
Time frame: Baseline, 1 week, and 1 month.
Subjective comfort on insertion (0-100 Visual Analogue Scale)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fanfilcon A Toric Contact Lens in people with Astigmatism, 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 9 inclusion and 9 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: opening soon, as of the sponsor's last update on 5 Nov 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jose Vega, O.D., MSc., PhD, FAAO (9256402964, JVega2@coopervision.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective Comfort (time frame: Baseline, 1 week, and 1 month.). 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 5 Nov 2026.