ClinicalTrials.gg
Not yet recruitingNCT07898995Updated Nov 5, 2026

Clinical Performance and Outcomes After Toric Lens Transition

An interventional study of Fanfilcon A Toric Contact Lens in Astigmatism, sponsored by CooperVision International Limited (CVIL). Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.

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

Updated Nov 5, 2026Primary outcomes revisedNewly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
35
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Astigmatism

Keywords

  • 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 35 is below 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.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 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

  1. Participants with eyes appropriate for the study being conducted.
  2. They are at least 18 years of age.
  3. They understand their rights as a research participant and are willing and able to sign a Statement of .
  4. 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.
  5. Anisometropia no greater than 1.50D, based on contact lens power spherical equivalent.
  6. Can achieve visual acuity of at least 0.1 logMAR (20/25) in each eye with contact lenses.
  7. Able to wear the study contact lenses for 6 days a week, minimum 8 hours a day.
  8. Can be fitted with the study contact lenses (Avaira Vitality® toric).
  9. They agree not to participate in any other clinical research study while enrolled in this study.

Exclusion criteria

Exclusion Criteria:

  1. Anterior segment infection, inflammation or abnormality
  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 (ISO scale).
  7. Inactive (i.e. ghost) vessels greater than 1 mm of penetration into the cornea
  8. They have corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
  9. They have participated in a contact lens or lens care product trial in past 30 days
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
35 participants (estimated)

Study arms

  • Experimental
    Refit to Fanfilcon A Toric Contact Lens

    Habitual wears of Confilcon A soft toric contact lenses Refitted to Fanfilcon A toric contact lenses and followed for one month.

    Device: Fanfilcon A Toric Contact Lens

Interventions

  • DeviceFanfilcon A Toric Contact Lens

    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.

06

What researchers measure

Primary outcomes

  1. Subjective Comfort

    Subjective comfort on insertion (0-100 Visual Analogue Scale)

    Time frame: Baseline, 1 week, and 1 month.

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

2 registry updates since Sep 25, 2026
Primary outcomes
1 time frame changed, 1 description edited
What changed in the outcomes
  • Time frameSubjective Comfort1 week, 2 week and 1 month. → Baseline, 1 week, and 1 month.
  • DescriptionSubjective Comfort: how it is measured was reworded
Nov 5, 2026
Registered
First appeared on the registry
Oct 27, 2026
Show all 2 updates
  1. Nov 5, 2026
    Primary outcomes 1 time frame changed, 1 description edited
    What changed in the outcomes
    • Time frameSubjective Comfort1 week, 2 week and 1 month. → Baseline, 1 week, and 1 month.
    • DescriptionSubjective Comfort: how it is measured was reworded
  2. Oct 27, 2026
    First appeared on the registry

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
NCT07898995
Responsible party
Sponsor
First posted
Oct 27, 2026
Start date
Nov 2026 (estimated)
Primary completion
Feb 2027 (estimated)
Completion
Feb 2027 (estimated)
Last update
Nov 5, 2026

Study contacts

Jose Vega, O.D., MSc., PhD, FAAO
Contact
JVega2@coopervision.com
9256402964

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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