Ask to take part

Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Mrs Shawna Bryant
+44 (0)2380 247120
sBryant3@coopervision.co.uk


Study Location:

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Be Part of Research - Trial Details - Post-market clinical follow-up for stenfilcon A sphere and toric lenses
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Post-market clinical follow-up for stenfilcon A sphere and toric lenses

Recruiting

Open to: All Genders

Age: Mixed

Glasgow Hereford St Albans Norwich

Medical Conditions

Myopia, astigmatism, hyperopia

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


The justification for this study is to confirm the current safety and efficacy of the lens as compared to similar marketed devices and to address long-term safety and performance in users of the lens. The choice of comparator devices was made to assess the clinical performance of the Test lens against currently marketed state-of-the-art products for the same indication.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 Apr 2024 30 Jun 2025

A single-visit, observational study design has been chosen to reduce the burden on patients and doctors using the device, while assessing outcomes in a real-world environment.

Recruitment:
Subjects will be recruited from the site's own patient listings based in England and Scotland.

Consenting:
Informed consent shall be obtained in writing from adult subjects, and assent and parental permission/consent from minors and their parent or legal guardian. The process shall be performed by an appropriately trained/delegated study member and will be documented before any procedure specific to the clinical investigation is carried out. The study members will be trained in the conduct of clinical research, show willingness to follow the study protocol and will be trained in GCP and the study protocol before commencing the study.


Patients aged between 8 and 75 years old who are current wearers of the Stenofilcon A sphere, toric or multifocal contact lens or similar marketed soft contact lens

You can take part if:



You may not be able to take part if:


1. Participation in a contact lens or contact lens care product clinical trial within the previous 30 days


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Peter Ivans Eye Care
    72 Drymen Road Bearsden
    Glasgow
    G61 2RH
  • Bbr Optometry Ltd
    Marbury House 38 St. Owen Street
    Hereford
    HR1 2PR
  • Leightons
    5 The Broadway
    St Albans
    AL1 3LH
  • Coleman Opticians
    7-11 St. Augustines Street
    Norwich
    NR3 3DH

Potential benefits:
There may not be direct benefits to the subjects in this study, however, participation in the study may contribute to scientific information that may be used in the development of new contact lens products.
The knowledge gained from this study may lead to important conclusions regarding the real-world safety and efficacy of this device. The potential risks for participating in this study are minimal, therefore the benefit-risk ratio is acceptable.
Participants will already be routinely wearing these lenses, and therefore this is considered a non-significant risk study. Routine, non-invasive procedures will be conducted in this study.

Mrs Shawna Bryant
+44 (0)2380 247120
sBryant3@coopervision.co.uk



The study is sponsored by CooperVision and funded by CooperVision.



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What will you do next?
Read full details for Trial ID: ISRCTN61640561
Last updated 07 March 2025

This page is to help you find out about a research study and if you may be able to take part

You can print or share the study information with your GP/healthcare provider or contact the research team directly.   

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