Contact Lenses for Astigmatism
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.12345
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.12678
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment - Period 1
Participants wear Control Contact Lens (stenfilcon A Sphere) for one week
Treatment - Period 2
Participants wear Test Contact Lens (stenfilcon A Toric) for one week
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
2
Treatment groups
Experimental Treatment
All participants will wear Test Contact Lens for one week (Period 2).
All participants will wear Control Contact Lens for one week (Period 1).
Find a Clinic Near You
Who Is Running the Clinical Trial?
CooperVision International Limited (CVIL)
Lead Sponsor
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
Citations
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.
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 ...
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 ...
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.
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 ...
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-lensThe 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
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