Post-market clinical follow-up for stenfilcon A sphere and toric lenses
| ISRCTN | ISRCTN61640561 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61640561 |
| IRAS number | 336756 |
| Secondary identifying numbers | IRAS 336756 |
- Submission date
- 13/11/2023
- Registration date
- 26/03/2024
- Last edited
- 07/03/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Eye Diseases
Plain English Summary
Background and study aims
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.
Who can participate?
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
What does the study involve?
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.
What are the possible benefits and risks of participating?
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.
Potential risks:
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.
Where is the study run from?
Sierra Clinical Services (USA)
When is the study starting and how long is it expected to run for?
August 2023 to June 2025
Who is funding the study?
Cooper Vision (USA)
Who is the main contact?
1. Shawna Bryant (Clinical Research Associate), sBryant3@coopervision.co.uk
2. Kathryn Richdale (Clinical Research Fellow), krichdale@coopervision.com
Contact information
Public
36 School Lane
Chandlers Ford
Eastleigh
SO53 4LY
United Kingdom
| Phone | +44 (0)2380 247120 |
|---|---|
| sBryant3@coopervision.co.uk |
Study information
| Study design | Prospective single-visit open-label observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Population study |
| Study setting(s) | 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 post-market safety and performance of stenfilcon A sphere, toric and multifocal contact lenses |
| Study acronym | CV-23-68 |
| Study hypothesis | Current study hypothesis as of 07/03/2025: The objective of this post-marketing study is to demonstrate acceptable safety and effectiveness (performance) of Stenfilcon A Sphere, Toric and Multifocal lenses compared with similar marketed state-of-the-art devices when used in the general population. Previous study hypothesis: The objective of this post-marketing study is to demonstrate acceptable safety and effectiveness (performance) of Stenfilcon A Sphere & Toric lenses compared with similar marketed state-of-the-art devices when used in the general population. |
| Ethics approval(s) |
1. Approved 27/02/2024, South Central - Oxford A Research Ethics Committee (Ground Floor, Temple Quay House, 2 The Square, Bristol, BS1 6PN, United Kingdom; +44 (0)207 1048171, +44 (0)207 104 8141, +44 (0)207 104 8272; oxforda.rec@hra.nhs.uk), ref: 24/SC/0070 - Protocol V1.0 2. Approved 18/02/2025, South Central Oxford A Research Ethics Committee (2 The Square, Bristol, BS1 6PN, United Kingdom; -; oxforda.rec@hra.nhs.uk), ref: 24/SC/0070 - Protocol V2.0 |
| Condition | Myopia, astigmatism, hyperopia |
| Intervention | The potential participant will attend the clinic for one study visit wearing the study contact lenses and having worn the study contact lenses for at least 3 hours that day. 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 they identify any adverse event associated with wearing Comfilcon A contact lenses that may have occurred are identified and analysed. 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 [3]: 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) | Stenofilcon A sphere, toric, multifocal contact lens |
| Primary outcome measure | 1. Visual performance measured using a visual acuity chart at the single study visit 2. Incidence of contact lens-related adverse events measured using a report of contact lens related adverse events in the past 12 months at the single study visit |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 17/08/2023 |
| Overall study end date | 30/06/2025 |
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 | 135 |
| Participant inclusion criteria | Current participant inclusion criteria as of 07/03/2025: 1. Aged 8 to 75 years old (inclusive) 2. Current wearer of the Stenfilcon A Sphere, Toric or Multifocal contact lens Previous participant inclusion criteria: 1. Aged 8 to 75 years old (inclusive) 2. Current wearer of the Stenfilcon A Sphere or Toric contact lens |
| Participant exclusion criteria | 1. Participation in a contact lens or contact lens care product clinical trial within the previous 30 days |
| Recruitment start date | 01/04/2024 |
| Recruitment end date | 30/06/2025 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
Study participating centres
Bearsden
Glasgow
G61 2RH
United Kingdom
38 St. Owen Street
Hereford
HR1 2PR
United Kingdom
St Albans
AL1 3LH
United Kingdom
Norwich
NR3 3DH
United Kingdom
Sponsor information
Industry
5870 Stoneridge Drive
Pleasanton
CA 94588
United States of America
| Phone | +1 (0)917 755 4548 |
|---|---|
| krichdale@coopervision.com | |
| Website | https://coopervision.com/ |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 30/06/2025 |
|---|---|
| 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
07/03/2025: The following changes were made:
1. The scientific title was changed from "This study aims to assess post-market safety and performance of stenfilcon A sphere & toric".
2. The study hypothesis and participant inclusion criteria were amended.
3. Drug/device/biological/vaccine name(s) were changed from "Stenofilcon A sphere or toric contact lens".
4. Ethics approval added.
5. The target number of participants was changed from 105 to 135.
6. The recruitment end date was changed from 31/12/2024 to 30/06/2025.
7. Bbr Optometry Ltd, Leightons, and Coleman Opticians were added as study participating centres.
12/02/2025: The overall study end date was changed from 28/02/2025 to 30/06/2025.
25/10/2024: The following changes were made to the study record:
1. The recruitment end date was changed from 31/10/2024 to 31/12/2024.
2. The overall study end date was changed from 31/12/2024 to 28/02/2025.
3. The intention to publish date was changed from 30/04/2025 to 30/06/2025.
23/08/2024: The following changes were made to the study record:
1. The recruitment end date was changed from 17/08/2024 to 31/10/2024.
2. The overall study end date was changed from 17/08/2024 to 31/12/2024.
3. The intention to publish date was changed from 01/04/2025 to 30/04/2025.
20/03/2024: Study's existence confirmed by South Central - Oxford A Research Ethics Committee.
