Toric Soft Contact Lenses for Astigmatism

No longer recruiting at 21 trial locations

Overseen By Alcon Call Center

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Alcon Research

Disqualifiers: Current P1fA, MDT wearers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 16 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two types of daily disposable soft contact lenses for people with astigmatism, a common condition that causes blurred vision. The aim is to determine if PRECISION1™ for Astigmatism (Stenfilcon A toric soft contact lenses) provides as clear distance vision as MyDay® toric (Verofilcon A toric soft contact lenses). Participants will wear each brand for just over a week to assess their effectiveness. The trial seeks individuals who have successfully worn toric (astigmatism-correcting) soft contact lenses for at least three months, at least five days a week, and ten hours a day. Participants must also agree not to use rewetting or lubricating drops during the study. As an unphased trial, this study allows participants to contribute to advancements in vision care by helping researchers understand the effectiveness of different contact lenses for astigmatism.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does mention that you should not use rewetting or lubricating eye drops during the study.

What prior data suggests that these contact lenses are safe for use?

Research shows that both types of contact lenses in this trial have undergone thorough safety studies. Stenfilcon A toric soft contact lenses, often called MyDay®, are used by people with astigmatism and have FDA approval for daily wear. This approval indicates they are generally safe and comfortable, with no serious side effects reported in past studies.

Verofilcon A toric soft contact lenses, known as PRECISION1™ for Astigmatism, have also been tested for safety. One study found that all users experienced good lens movement, a positive sign for comfort and safety. These lenses are also approved for daily use, confirming their safety.

Both lenses are designed for single-day use and disposal, reducing the risk of infection associated with longer-wear lenses. Overall, current research suggests both lenses are safe choices. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these toric soft contact lenses because they offer a fresh approach to correcting astigmatism. Unlike standard lenses, both stenfilcon A and verofilcon A are designed for daily disposal, which can enhance hygiene and convenience for users. Additionally, these lenses are crafted to provide consistent comfort and vision clarity throughout the day. This trial aims to compare the performance and user experience of these two innovative lenses, potentially setting new standards for comfort and effectiveness in the world of contact lenses.

What evidence suggests that these contact lenses are effective for astigmatism?

In this trial, participants will wear both Stenfilcon A and Verofilcon A toric soft contact lenses in different sequences. Research has shown that users generally like Stenfilcon A toric soft contact lenses. One study found that over 80% of participants were very satisfied or satisfied with the lenses' performance, indicating that these lenses usually provide clear vision and comfort for most people.

Verofilcon A toric soft contact lenses have also delivered good results. Studies find that they settle on the eye quickly, in about 60 seconds, and remain in the correct position. Users have rated them highly for both vision quality and comfort. Both types of lenses are designed to provide clear vision for people with astigmatism and have effectively improved visual acuity. ^{6 7 8 9 10}

Who Is on the Research Team?

Sr. Clinical Trial Lead, Vision Care

Principal Investigator

Alcon Research, LLC

Are You a Good Fit for This Trial?

Inclusion Criteria

Successful wearers of toric soft contact lenses in both eyes with at least 3 months wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day.

Other protocol-defined inclusion criteria may apply.

Able to wear contact lenses within a range of sphere & cylinder power and axes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants wear each study lens type in a randomized, crossover sequence for 8 days each, with lenses worn for at least 10 hours per day

16 days

4 visits (in-person)

Follow-up

Participants are monitored for visual acuity and safety after wearing each lens type

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Stenfilcon A toric soft contact lenses
• Verofilcon A toric soft contact lenses

How Is the Trial Designed?

Group I: P1fA, then MDT Experimental Treatment 2 Interventions

Verofilcon A toric soft contact lenses worn first, followed by stenfilcon A toric soft contact lenses, as randomized. Each study lens type will be worn for 8 (-0/+3) days for at least 10 hours per day. Lenses will be removed nightly and disposed of after a single use.

Group II: MDT, then P1fA Experimental Treatment 2 Interventions

Stenfilcon A toric soft contact lenses worn first, followed by verofilcon A toric soft contact lenses, as randomized. Each study lens type will be worn for 8 (-0/+3) days for at least 10 hours per day. Lenses will be removed nightly and disposed of after a single use.

Who Is Running the Clinical Trial?

Alcon Research

Lead Sponsor

Trials

739

Recruited

128,000+

Raquel C. Bono

Alcon Research

Chief Medical Officer since 2022

MD from Harvard Medical School

David Endicott

Alcon Research

Chief Executive Officer since 2018

MBA from University of Southern California

Published Research Related to This Trial

The novel daily disposable contact lens made from verofilcon A showed superior pre-lens tear film stabilization and visual performance compared to other materials after 28 days of use in healthcare professionals, particularly under mask-wearing conditions.

Subjects using verofilcon A experienced better contrast sensitivity and longer non-invasive tear break up times, likely due to its unique surface technology and high water content, which helps maintain eye comfort and clarity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the Pre-Lens Tear Film Stability and Visual Performance of a Novel and Two Other Daily Disposable Contact Lenses in Healthcare Professionals Wearing Facial Masks for Prolonged Time. Penbe, A., Kanar, HS., Donmez Gun, R.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11761843/

Performance of a Toric, Monthly, Soft Contact Lens in ... Overall, how satisfied are you with the performance of the study contact lenses? Very Satisfied: 43.8%. Satisfied: 37.5%. Indifferent: 14.6%.

2. withpower.com withpower.com/trial/phase-refractive-errors-8-2022-d8ae5

Clinical Comparison of Two Daily Disposable Toric Soft ... The novel daily disposable contact lens made from verofilcon A showed superior pre-lens tear film stabilization and visual performance compared to other ...

3. researchgate.net researchgate.net/publication/388209209_Performance_of_a_Toric_Monthly_Soft_Contact_Lens_in_Digital_Device_Users

(PDF) Performance of a Toric, Monthly, Soft Contact Lens ... 26 The lenses performed well after 1 month, with 88% agreeing that the lenses provided good performance when using a digital device for at least ...

4. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/27/NCT05483127/SAP_001.pdf

Clinical Performance of Two Daily Disposable Toric Soft ... A listing of select effectiveness data will also be provided. 4.1 Effectiveness Endpoints. Primary Effectiveness Endpoint. The primary effectiveness endpoint is ...

5. isrctn.com isrctn.com/pdf/61640561

Post-market clinical follow-up for stenfilcon A sphere and ... A single-visit, observational study design has been chosen to reduce the burden on patients and doctors using the device, while assessing ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02801006

The Clinical Study of Silicone Hydrogel Daily Disposable ... The aim of this study is to evaluate the clinical performance of stenfilcon A toric lenses compared with etafilcon A toric lenses for astigmatism. If it is ...

7. coopervision.com.hk coopervision.com.hk/sites/coopervision.com.hk/files/myday_sphere_toric.pdf

MyDay (stenfilcon A) Daily Disposable Soft Contact Lenses The radiation blockage of the MyDay (stenfilcon A) lens will increase for thicker lenses (Please refer to accompanying transmittance curve graph).

8. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf22/K220070.pdf

K220070.pdf - accessdata.fda.gov The lenses may be worn by persons who exhibit astigmatism of -2.00 diopters or less that does not interfere with visual acuity. MyDay ( ...

9. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf4/k042275.pdf

OCT 2 82004 Summary of Safety and Effectiveness The VISTAKON® (senofilcon A) Toric Contact Lens is indicated for daily wear for the correction of visual acuity in phakic or aphakic persons ...

10. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf4/P040045b.pdf

senofilcon A hydrophilic contact lens De - accessdata.fda.gov SUMMARY OF SAFETY AND EFFECTIVENESS DATA​​ The VISTAKON® (senofilcon A) Toric Soft Contact Lens is indicated for the optical correction of visual acuity in ...