Clinical investigation of soft contact lenses in children
| ISRCTN | ISRCTN17872996 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17872996 |
| IRAS number | 357884 |
| Secondary identifying numbers | MKTG-166 |
- Submission date
- 03/10/2025
- Registration date
- 13/10/2025
- Last edited
- 13/10/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
The number of adolescents with myopia (short-sightedness) has been increasing rapidly over the last twenty years. The concern is that individuals with short-sighted eyes are more likely to develop eye diseases such as ocular pathology than individuals with healthy eyes. In order to minimize short-sightedness and potential problems later in life, various methods have been developed to reduce the effect of myopia. An example of a method used to reduce the impact of myopia is the use of special designed disposable contact lenses. This study aims to assess the short-term performance of a similar control lens versus CooperVision's test contact lenses in myopic children.
Who can participate?
Children (8 - 15 years) who have experience with soft contact lens wear, and can apply and remove soft contact lenses.
What does the study involve?
The participants will attend the visit wearing their glasses. The participant's habitual contact lenses should not be worn on the day of the visit. The visit is expected to take approximately 2.5 hours. The following procedures will be performed:
• Read and sign Informed Consent/Assent and Parental Permission/Consent. When the participant and parent have signed the appropriate forms, the participant will be considered to
be enrolled in the study.
• Demographics
• Medical and ocular health history
• Contact lens and refractive history
. 1st contact lens application
- Subjective responses
- Vision
- Lens fit
. 2nd contact lens application
- Subjective responses
- Vision
- Lens fit
. Lens removal
• Review of adverse events
• Study exit.
What are the possible benefits and risks of participating?
Participants have the opportunity to try contact lenses to help their vision and control the progression of their myopia. Any contact lens wear comes at the risk of corneal infection, but the incidence rate is very low.
Where is the study run from?
Eurolens Research, University of Manchester (UK).
When is the study starting, and how long is it expected to run for?
August 2025 to March 2026
Who is funding the study?
CooperVision International Limited (USA)
Who is the main contact?
Jose Vega, OD, MSc, PhD, FAAO
jvega2@coopervision.com
Contact information
Public, Scientific
2120 West Guadalupe Road, Suite 112
Gilbert
85233
United States of America
| Phone | +1-925-640-2964 |
|---|---|
| jvega2@coopervision.com |
Public, Principal investigator
Carys Bannister building
Division of Pharmacy and Optometry, Faculty of Biology, Medicine and Health. The University of
Manchester, Dover St.
Manchester
M13 9PL
United Kingdom
| Phone | +44 (0)161 306 8761 |
|---|---|
| carole.m-codina@manchester.ac.uk |
Public
6101 Bollinger Canyon Road, Suite 500
San Ramon
94583
United States of America
| Phone | +1-925-353-8425 |
|---|---|
| kokaur@coopervision.com |
Public
Delta Park, Concorde Way, Segensworth North
Fareham
PO15 5RL
United Kingdom
| Phone | +44 7974858818 |
|---|---|
| Archana.Binod-Nair@coopervision.co.uk |
Study information
| Study design | Single-visit randomized double-masked non-dispensing study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Clinical performance of two myopia control contact lenses in children |
| Study acronym | CPTMCCLC |
| Study objectives | The objective of this study is to assess the short-term performance of senofilcon A (control lens) versus stenfilcon A (test lens) silicone hydrogel daily disposable contact lenses in myopic children. |
| Ethics approval(s) |
Approved 14/08/2025, West Midlands - Edgbaston Research Ethics Committee (2 Redman Place, Stratford, E20 1JQ, United Kingdom; +44 20 7104 8260; edgbaston.rec@hra.nhs.uk), ref: 25/WM /0127 |
| Health condition(s) or problem(s) studied | Myopia |
| Intervention | The study will be a randomized, double-masked, non-dispensing, prospective study involving a single visit with approximately 2.5 hours of wear, to assess the short-term performance of senofilcon A (control lens) versus stenfilcon A (test lens) contact lenses in myopic children. The order in which the two study contact lenses will be fitted will be randomized to minimise bias. Block randomization will be computer-generated based on the maximum enrollment number. Participants will be assigned a participant ID, and this number will be linked to the randomisation assignment. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable, Contact Lens |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Stenfilcon A 1-day contact lenses |
| Primary outcome measure | High contrast, high luminance binocular distance visual acuity measured using the Precision-Vision Chart 2425-LED-200, at the one-day single visit. The visit is expected to take approximately 2.5 hours. |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 14/08/2025 |
| Completion date | 18/03/2026 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Child |
| Lower age limit | 8 Years |
| Upper age limit | 15 Years |
| Sex | All |
| Target number of participants | 35 |
| Key inclusion criteria | 1. Age 8 to 15 years (inclusive) 2. Current wearer of spherical soft contact lenses 3. The parent or guardian understands the study and rights of the participant and is willing to sign a statement of informed consent. 4. The participant understands the study at a level appropriate for their age and is willing to sign a statement of assent. |
| Key exclusion criteria | 1. Previous use of myopia control contact lenses. 2. Active anterior segment infection, inflammation, or abnormality that would contraindicate contact lens wear. 3. Use of systemic or ocular medication that would contraindicate contact lens wear 4. Used gas permeable/hard contact lenses (including orthokeratology) in the previous 3 months. 5. Participation in a contact lens or lens care product trial in the previous 30 days. |
| Date of first enrolment | 25/09/2025 |
| Date of final enrolment | 18/03/2026 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Manchester
M13 9PL
United Kingdom
Sponsor information
Industry
Delta Park, Concorde Way, Segensworth North
Fareham
PO15 5RL
England
United Kingdom
| Phone | +1489 883000 |
|---|---|
| jvega2@coopervision.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available, Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The data sharing plans for the current study are unknown. 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. |
Editorial Notes
06/10/2025: Trial's existence confirmed by West Midlands - Edgbaston Research Ethics Committee.
