Contact Lenses for Astigmatism

Overseen By Percy Lazon, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: CooperVision International Limited (CVIL)

Must not be taking: Systemic medications

Disqualifiers: Ocular disease, Allergies, Surgery, others

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

Compensation: Varies

Number of Visits: 9

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two types of soft contact lenses, stenfilcon A Sphere and stenfilcon A Toric, to determine which is more effective for people with astigmatism, a condition that causes blurry vision. Participants will wear each lens type for a week and provide feedback on comfort and clarity. This trial suits those who regularly wear spherical soft contact lenses and have mild astigmatism in both eyes. Participants should also be able to wear the study lenses for most of the week and complete short online surveys. As an unphased trial, this study allows participants to contribute to research that could enhance vision correction options for astigmatism.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are using any medications that might affect the study or contact lens wear, the investigator may advise you to stop.

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

Previous studies have shown that stenfilcon A lenses, available in both Sphere and Toric types, are safe for people with astigmatism. Research indicates that users generally tolerate these lenses well. Reports from users show minimal discomfort and few negative side effects. The FDA has already approved the lenses for certain conditions, which adds confidence in their safety. This suggests that both the Sphere and Toric versions are generally safe for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about stenfilcon A Toric contact lenses because they offer a potential new solution for people with astigmatism. Unlike traditional contact lenses that may not fit perfectly on an irregularly shaped cornea, stenfilcon A Toric lenses are specifically designed to provide a more customized fit and improved vision correction for astigmatism. This new design could lead to better comfort and sharper vision compared to standard spherical lenses. The hope is that these lenses will offer a significant improvement in both vision quality and wearer comfort.

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

This trial will compare stenfilcon A Sphere lenses with stenfilcon A Toric lenses. Studies have shown that stenfilcon A Toric lenses can improve vision for people with astigmatism. One study found these lenses performed well compared to other toric lenses, which are designed to correct vision for those with an uneven curve in their eye. Another survey revealed mixed opinions, with only 60% of eye specialists agreeing that toric lenses provide better vision for mild astigmatism. However, many patients express high satisfaction with similar lenses, such as nesofilcon A. This suggests that stenfilcon A Toric lenses could effectively correct astigmatism. ^{1 2 6 7 8}

Who Is on the Research Team?

Lyndon Jones, PhD,FCOptom

Principal Investigator

Centre for Ocular Research and Education

Are You a Good Fit for This Trial?

This trial is for individuals with low astigmatism and may also have near-sightedness or farsightedness. Specific eligibility criteria are not provided, but typically participants must meet certain vision and eye health requirements.

Inclusion Criteria

Have specific astigmatism values in each eye

Achieves specific visual acuity in each eye

Fit with available study contact lens powers

Exclusion Criteria

Employee of the Centre for Ocular Research & Education directly involved in the study

Participating in any concurrent clinical interventional study

Worn rigid contact lenses in the last 3 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment - Period 1

Participants wear Control Contact Lens (stenfilcon A Sphere) for one week

1 week

Day 1 (in-person), Day 7 (in-person)

Treatment - Period 2

Participants wear Test Contact Lens (stenfilcon A Toric) for one week

1 week

Day 8 (in-person), Day 13 (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• stenfilcon A Sphere
• stenfilcon A Toric

Trial Overview The study aims to compare the performance of two types of soft contact lenses: a control lens (stenfilcon A Sphere) for standard vision correction, and a test lens (stenfilcon A Toric) designed specifically for astigmatism.

How Is the Trial Designed?

Group I: Test Contact Lens (stenfilcon A Toric) Experimental Treatment 1 Intervention

All participants will wear Test Contact Lens for one week (Period 2).

Group II: Control Contact Lens (stenfilcon A Sphere) Experimental Treatment 1 Intervention

All participants will wear Control Contact Lens for one week (Period 1).

Who Is Running the Clinical Trial?

CooperVision International Limited (CVIL)

Lead Sponsor

Trials

171

Recruited

14,600+

Dr. Patrizia Cavazzoni

CooperVision International Limited (CVIL)

Chief Medical Officer

MD from Harvard Medical School

Steven Robins

CooperVision International Limited (CVIL)

President, Americas

Bachelor of Arts from Bates College, participated in Pfizer Global Leadership Program with Harvard University

Centre for Ocular Research & Education, Canada

Collaborator

Trials

14

Recruited

2,600+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6331137/

Satisfaction of astigmatic patients with toric nesofilcon A ... As a measure of general satisfaction, 96% of patients indicated that their overall opinion of the toric nesofilcon A lens was good to excellent.

2. 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 ...

3. isrctn.com isrctn.com/pdf/61640561

Post-market clinical follow-up for stenfilcon A sphere and ... effectiveness (performance) of Stenfilcon A Sphere, Toric and Multifocal lenses compared with similar marketed state-of-the-art devices when ...

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

Clinical Comparison of Two Daily Disposable Toric Soft ... 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 ...

5. contactlensupdate.com contactlensupdate.com/2024/06/19/can-we-mask-corneal-astigmatism-with-soft-lenses/

Can we mask corneal astigmatism with soft lenses? A recent survey determined that only 60% of eye care practitioners agreed that toric lenses provide better visual acuity for low astigmats.

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf13/K131378.pdf

1K1313-1 S - accessdata.fda.gov The lenses may be worn by persons who exhibit astigmatism of -2.00 D or less that does not Interfere with visual acuity. Toric. SUS (stenfilcon ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6842293/

Objective Evaluation Of On-Eye Optical Quality Of Daily ... The senofilcon A lens had significantly lower average total HOAs, FI, and SI (p<0.001, p=0.001, p=0.007, respectively) than the etafilcon A lens. After 1-week ...

8. ctv.veeva.com ctv.veeva.com/study/the-clinical-study-of-silicone-hydrogel-daily-disposable-stenfilcon-a-toric-lens

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