Clinical study of a range of soft contact lens brands
| ISRCTN | ISRCTN12617867 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12617867 |
| Secondary identifying numbers | CV-23-91 |
- Submission date
- 09/08/2024
- Registration date
- 16/08/2024
- Last edited
- 16/08/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Eye Diseases
Plain English Summary
Background and study aims
The aim of this study is to confirm the current safety and effectiveness of sphere, toric, and multifocal lenses compared to similar marketed devices and to address the long-term safety and performance of daily wear in users of these lenses. The choice of lenses was made to assess the clinical performance of the test lenses against currently marketed state-of-the-art products for the same indication.
Who can participate?
Patients aged between 8 and 75 years old who are current wearers of CE-marked CooperVision test or control lenses. Equivalent private-label contact lenses can be included in either group (for at least 6 months)
What does the study involve?
The participants 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 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 identify any adverse events associated with wearing study test or control lenses.
What are the possible benefits and risks of participating?
There may not be direct benefits to the participants, but participation 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 effectiveness of these lenses. The potential risks are minimal so the benefit-risk ratio is acceptable. Participants will already be routinely wearing these lenses so this is considered a non-significant risk study. Routine non-invasive procedures will be conducted in this study.
Where is the study run from?
Eurolens (UK)
When is the study starting and how long is it expected to run for?
December 2023 to July 2025
Who is funding the study?
CooperVision Inc., Ltd (USA)
Who is the main contact?
1. Poonam Chowdhary (Senior Clinical Research Associate) PChowdhary@coopervision.co.uk
2. Kenny Tran (Senior Clinical Scientist) ktran2@coopervision.com
Contact information
Public
R&D Facility
36 School Lane
Chandlers Ford
Eastleigh
Eastleigh
SO53 4LY
United Kingdom
| Phone | +44 (0)794293631 |
|---|---|
| PChowdhary@coopervision.co.uk |
Scientific
5870 Stoneridge Drive
Pleasanton
94588
United States of America
| Phone | +1 (0)9253538907 |
|---|---|
| KTran2@coopervision.com |
Principal Investigator
Eurolens Research
The University of Manchester
Manchester
M13 9PL
United Kingdom
| Phone | +44 (0)161 306 4441 |
|---|---|
| philip.morgan@manchester.ac.uk |
Study information
| Study design | Prospective single-visit open-label observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Population study |
| Study setting(s) | Medical and other records, Optician |
| Study type | Safety, Efficacy |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | This study aims to assess the post-market safety and performance of a range of contact lens types |
| Study hypothesis | The objective of this post-market study is to demonstrate acceptable safety and effectiveness (performance) of a range of CooperVision soft contact lens types compared with similar marketed devices, when used in the general population. |
| Ethics approval(s) |
Approved 02/07/2024, University Research Ethics Committees (URECs) (2nd Floor, The Christie Building, The University of Manchester, Oxford Road, Manchester, M13 9PL, United Kingdom; +44 (0)161 306 6000; urec1@manchester.ac.uk), ref: 2024-20572-36344 |
| Condition | Myopia, astigmatism, hyperopia, presbyopia |
| Intervention | 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, vision and handling 3. Subjective rating of contact lens fit and contact lens surface characteristics The performance will be tested for safety as per ISO11980-2012: 1. Identification of ocular adverse events related to contact lens wear 2. Measurement of spectacle logMAR visual acuity 3. Assessment of the ocular tissues and ratings as per ISO11980-2012 scales |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Range of soft contact lens brands |
| Primary outcome measure | 1. Visual performance (visual acuity) measured based on high-contrast visual acuity at one timepoint 2. Incidence of contact lens-related adverse events measured using subject reports and slit lamp evaluation |
| Secondary outcome measures | Relationship determination between lens fit, surface measurements, and subjective scores measured using appropriate statistical modeling, slit lamp evaluation, and VAS/ISO Questionnaires at one timepoint |
| Overall study start date | 05/12/2023 |
| Overall study end date | 01/07/2025 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Mixed |
| Lower age limit | 8 Years |
| Upper age limit | 75 Years |
| Sex | Both |
| Target number of participants | 700 |
| Participant 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 |
| Participant exclusion criteria | Participation in a contact lens or contact lens care product clinical trial within the previous 30 days |
| Recruitment start date | 01/08/2024 |
| Recruitment end date | 30/12/2024 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
Study participating centre
Oxford Road
Manchester
M13 9PL
United Kingdom
Sponsor information
Industry
5870 Stoneridge Drive
Pleasanton
94588
United States of America
| Phone | +1 (0)9253538907 |
|---|---|
| KTran2@coopervision.com | |
| Website | https://coopervision.com/ |
Funders
Funder type
Industry
Government organisation / For-profit companies (industry)
- Alternative name(s)
- CooperVision, Inc., CooperVision Inc, CooperVision Inc., CooperVision, Inc
- Location
- United States of America
Results and Publications
| Intention to publish date | 01/07/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Due to the confidential and proprietary nature of the clinical study, any presentation and/or publication including but not limited to those made at scientific meetings, in-house, in peer-review journals, professional publications, etc. cannot be published without the written consent of the Sponsor. Details of the publication procedures are in the clinical study agreement. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to the confidential and proprietary nature of the clinical study. Details of the publication procedures are in the clinical study agreement. |
Editorial Notes
16/08/2024: Study's existence confirmed by University Research Ethics Committee 1, University of Manchester.
