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CompletedNCT05039112Updated Dec 7, 2021

Clinical Comparison of 2 Daily Disposable Toric Soft Contact Lenses

An interventional study of Verofilcon A toric contact lenses and Stenfilcon A toric contact lenses in Refractive Errors and Astigmatism, sponsored by Alcon Research. Completed at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-12-07.

Sponsored by Alcon Research · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study to evaluate the overall performance of PRECISION1™ for Astigmatism contact lenses with MyDay® Toric contact lenses.

Read the detailed description

Subjects will be expected to attend 4 visits and wear study lenses daily for approximately 10 hours per day. On the day prior to the Week 1 Follow-up visit of each crossover period, subjects will be asked to wear the respective study lens for at least 16 hours. The expected duration of subject participation in the study is approximately 3 weeks.

02

Conditions studied

  • Refractive Errors
  • Astigmatism

Keywords

  • Contact lenses
  • Daily disposable
03

In context

Astigmatism

413 studies on the registry are indexed under Astigmatism; 55 are open to participants now.

This study's enrollment of 64 is above the median of 55 across 321 interventional studies indexed under Astigmatism.

Browse Astigmatism studies →

Lead sponsor

Alcon Research is the lead sponsor of 608 studies on the registry; 9 are open to participants now.

Of its 109 completed or terminated interventional studies of FDA-regulated products, 99 (91%) 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

Eligibility criteria

Key Inclusion Criteria:

  • Successful wear of toric soft contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months.
  • Willing to wear study contact lenses for at least 16 hours on the day prior to the Week 1 Follow up visit of each lens type.
  • Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

  • Current/previous wear of PRECISION1 for Astigmatism or MyDay Toric contact lenses.
  • Current wear of spherical contact lenses.
  • Wears habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week).
  • Other protocol-defined exclusion criteria may apply.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
64 participants (actual)

Study arms

  • Other
    P1fA, then MyDay Toric

    Verofilcon A toric contact lenses worn first, with stenfilcon A toric contact lenses worn second, as randomized. Each product will be worn bilaterally (in both eyes) for 8 (-0/+3) days in a daily disposable modality.

    Device: Verofilcon A toric contact lenses · Device: Stenfilcon A toric contact lenses

  • Other
    MyDay Toric, then P1fA

    Stenfilcon A toric contact lenses worn first, with verofilcon A toric contact lenses worn second, as randomized. Each product will be worn bilaterally (in both eyes) for 8 (-0/+3) days in a daily disposable modality.

    Device: Verofilcon A toric contact lenses · Device: Stenfilcon A toric contact lenses

Interventions

  • DeviceVerofilcon A toric contact lenses

    Soft contact lenses for optical correction of astigmatism, used as indicated

    Also known as: PRECISION1 for Astigmatism, P1fA

  • DeviceStenfilcon A toric contact lenses

    Soft contact lenses for optical correction of astigmatism, used as indicated

    Also known as: MyDay Toric

06

What researchers measure

Primary outcomes

  1. Percent of lenses with axis orientation within ±30 degrees inclusive from the intended axis, 10 minutes after lens insertion

    Axis orientation (orientation of the scribe mark) will be assessed by slit lamp examination and recorded as deviations from intended axis.

    Time frame: Day 1, 10 minutes after lens insertion, each product

07

Study locations

6 sites
  • Alcon Investigator 6565
    Maitland, Florida 32751, United States
  • Alcon Investigator 6567
    Pittsburg, Kansas 66762, United States
  • Alcon Investigator 8097
    Sterling Heights, Michigan 48312, United States
  • Alcon Investigator 6313
    Powell, Ohio 43065, United States
  • Alcon Investigator 6401
    Warwick, Rhode Island 02888, United States
  • Alcon Investigator 6353
    Memphis, Tennessee 38111, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 7, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05039112
Lead sponsor
Alcon Research
Responsible party
Sponsor
First posted
Sep 9, 2021
Start date
Sep 28, 2021
Primary completion
Nov 29, 2021
Completion
Nov 29, 2021
Last update
Dec 7, 2021

Study contacts

Clinical Trial Lead, Vision Care
study director · Alcon Research, LLC

Oversight

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

Not currently enrolling

This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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