Clinical study of a range of soft contact lens brands

This study aims to assess the post-market safety and performance of a range of contact lens types

Registry ID
ISRCTN12617867
Source registry
ISRCTN
Status
Recruiting
Study type
OBSERVATIONAL
Sponsor
CooperVision Inc Ltd
Enrollment
700
Start date
2024-08-01
Completion date
2026-12-31
Last update
2026-08-17

Conditions

Summary

Myopia, astigmatism, hyperopia, presbyopia

Detailed description

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, as well as 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. The potential participant will attend the clinic for one study visit wearing the study test or control lenses. The visit will be about 2 hours long during which participants will be consented to participate in the study, complete a questionnaire, have their vision measured, the contact lens fit evaluated, and their eyes examined. In addition, the investigator will review participant clinical notes available at the practice site to ensure that any adverse events associated with wearing study tests or control lenses that may have occurred are identified and analysed. Please find below a list of the contact lenses ‘or similar’ tested:  Avaira Vitality Sphere  Proclear Sphere  Biomedics 55 Asphere  Biomedics Now Sphere  Avaira Vitality Toric  Proclear Toric and Toric XR  Biomedics Toric  Proclear Multifocal and Mulitfocal XR  Proclear Multifocal Toric  Clariti 1 day Daily Disposable Sphere  Biomedics 1 Day Extra-1 Day Sphere  Proclear - 1 Day – Sphere  Live 1 day  Clariti 1 day Daily Disposable Toric  Biomedics 1 Day Toric and EXTRA Toric  Clariti 1 day Daily Disposable Multifocal  Proclear 1 Day Multifocal The acceptance and performance of the contact lenses will be tested for efficacy as per ISO11980-2012: 1. Measurement of contact lens logMAR visual acuity 2. Subjective rating of comfort, visi

Interventions

Inclusion criteria

1. Age 8 to 75 years (inclusive) 2. They understand their rights as a research subject and are willing to sign a Statement of Informed Consent 3. Current wearer (for at least 6 months) of CE-marked CooperVision test or control lenses. Equivalent private-label contact lenses can be included in either group

Exclusion criteria

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

Locations

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