All studies
CompletedNot ApplicableObservational

Post-market clinical follow-up for stenfilcon A sphere and toric lenses

This UK observational study is checking the safety and performance of stenfilcon A soft contact lenses in everyday use. These lenses are commonly prescribed by opticians to correct short-sightedness, long-sightedness, and astigmatism. The makers of the lenses want to confirm how comfortable and effective they are compared with other standard lenses on the market. Taking part is straightforward because it involves just one single visit to a participating optician practice in England or Scotland. During this appointment, an eye care professional will carry out standard, non-invasive eye tests, very similar to a regular contact lens review. To be eligible, you must be between 8 and 75 years old and already wear stenfilcon A lenses or similar soft contact lenses. You cannot join if you have taken part in another contact lens trial within the past 30 days. Taking part carries minimal risk and helps improve future eye care products.

At a glance

Status
Completed
Phase
Not Applicable
Sponsor
CooperVision
Enrolment target
135
Start
01 Apr 2024
Estimated completion
03 Sep 2025

What is this study about?

Contact lenses are medical devices used by millions of people across the UK to help them see clearly. Even after a lens is approved and available to buy, manufacturers carry out follow-up studies to ensure the lenses continue to be safe, reliable, and comfortable over time. This type of research is called a post-market study, and it helps doctors understand how lenses perform in real-world conditions rather than just in a test laboratory.

This study focuses on daily soft contact lenses made from a material called stenfilcon A. These lenses are designed to correct common eyesight conditions, including myopia (short-sightedness), hyperopia (long-sightedness), and astigmatism (where an uneven eye shape causes blurred vision). Researchers want to compare feedback from people using stenfilcon A lenses against other standard soft lenses currently available in opticians.

Because the study observes people who already wear these lenses, it gives an accurate picture of everyday lens wear without disrupting participants' normal lives. The information gathered will help eye specialists ensure high standards of eye health and assist in designing even better, more comfortable contact lenses in the future.

Key takeaways

  • Checks the real-world comfort and safety of stenfilcon A contact lenses.
  • Open to everyday soft contact lens wearers aged between 8 and 75.
  • Requires only one single appointment at an optician in England or Scotland.
  • Involves only standard, painless eye checks with no experimental lenses.
  • Participation is voluntary and helps improve future contact lens designs.

Who may be eligible?

This study is open to adults and children aged between 8 and 75 years old living in England or Scotland. To take part, you must already be a regular wearer of stenfilcon A contact lenses (whether you use single-vision, toric lenses for astigmatism, or multifocal lenses) or a similar soft contact lens.

Children aged 8 and older can take part as long as their parent or legal guardian gives written permission and the child also agrees. Because the study only looks at people who already wear these lenses, you will not need to change your usual contact lens routine or brand.

You cannot take part if you have been involved in any other clinical trial testing contact lenses or contact lens cleaning solutions within the last 30 days.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you between 8 and 75 years old?
  2. Do you already wear stenfilcon A soft contact lenses (or a similar soft lens)?
  3. Are you a patient at a participating optician in England or Scotland?
  4. Have you been free from any other contact lens clinical trials for at least 30 days?
Answer every question to see your result.

What does participation involve?

Taking part in this study is designed to be simple and convenient. It involves just one single visit to an opticians practice in England or Scotland. There are no new medicines to take and no experimental lenses to test; you simply wear the lenses you normally use.

During your appointment, an eye care professional will carry out routine, gentle eye checks. These are the same types of non-invasive tests you would have during a normal contact lens check-up to see how your lenses fit, check your eye surface health, and test your vision. The visit usually takes less than an hour. Once your appointment is finished, your participation is complete, and no further follow-up visits are needed.

Potential risks and benefits

Because you will already be wearing these contact lenses in your daily life, the risks of taking part are considered very low. The eye tests are standard, routine, and completely painless. You may not experience any direct health benefits from taking part, but your involvement helps eye care specialists gather valuable information to improve future contact lens products. Joining this study is entirely your choice. You are free to withdraw at any point without giving a reason, and doing so will not affect your regular eye care in any way.

Locations (4)

  • Peter Ivans Eye Care
    City only
    Glasgow, Scotland
  • Bbr Optometry Ltd
    City only
    Hereford, England
  • Leightons
    Approximate
    St Albans, England
  • Coleman Opticians
    City only
    Norwich, England

Common questions

Will I have to try a brand-new or untested contact lens?

No. The study only involves lenses that are already approved, widely used, and that you already wear as part of your normal routine.

How many appointments will I need to go to?

You only need to attend one single appointment at a participating optician clinic.

Can children take part in this study?

Yes. Children aged 8 and older can join, provided their parent or guardian gives written permission and the young person also agrees.

Do the eye tests hurt?

Not at all. The checks are standard, gentle, and non-invasive, exactly like a normal contact lens check-up.

Will taking part cost me any money?

No, taking part in the study visit is free, and it will not change the normal arrangement you have for buying your lenses.

How to find out more

Archana Binod-Nair

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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