Clinical Comparison of Two Daily Disposable Toric Soft Contact Lenses

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

153 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing new soft contact lenses for people with astigmatism to see if they work as well as an existing product. The lenses help improve vision by adjusting how light enters the eye.

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 data supports the effectiveness of the treatment Stenfilcon A toric soft contact lenses, Verofilcon A toric soft contact lenses?

Research suggests that verofilcon A toric soft contact lenses provide fast stability and ease of fit, which are important for effective vision correction in people with astigmatism (a condition where the eye does not focus light evenly on the retina). Additionally, toric soft contact lenses, in general, are known to offer a wide visual field and comfort, making them a good option for correcting astigmatism. ^{1 2 3 4 5}

How do Stenfilcon A and Verofilcon A toric soft contact lenses differ from other treatments for astigmatism?

Stenfilcon A and Verofilcon A toric soft contact lenses are unique because they use advanced silicone hydrogel materials that provide better oxygenation and comfort, and they feature a novel design for rotational stabilization, which improves fit and stability on the eye compared to traditional lenses. ^{1 2 3 4 6}

Research Team

Sr. Clinical Trial Lead, Vision Care

Principal Investigator

Alcon Research, LLC

Eligibility Criteria

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

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

Treatment Details

Interventions

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

Participant Groups

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

Findings from Research

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]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Short-Term Fit Assessment of a Novel Daily Disposable, Toric, Silicone Hydrogel Contact Lens. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Clinical evaluation of a custom-made toric soft lens. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Inefficacy of aspheric soft contact lenses for the correction of low levels of astigmatism. [2022]

4. Romania pubmed.ncbi.nlm.nih.gov

[Now soft toric contact lenses; silicone hydrogel lens for astigmatism]. [2008]

5. New Zealand 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. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Soft contact lens fitting after intrastromal corneal ring segment implantation to treat keratoconus. [2022]