Clinical performance and safety of soft contact lenses in children
| ISRCTN | ISRCTN19818206 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN19818206 |
| Secondary identifying numbers | MKTG-171 |
- Submission date
- 03/10/2025
- Registration date
- 13/10/2025
- Last edited
- 13/10/2025
- Recruitment status
- Not yet 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. To minimize short-sightedness and potential problems later in life, various methods have been developed to reduce the effect of myopia. Some methods used to reduce the impact of myopia are the use of specially designed disposable soft contact lenses and spectacle lenses. This study aims to assess the performance of myopic control soft daily disposable contact lenses and spectacles in myopic children.
Who can participate?
Otherwise healthy children aged 8 to 12 years who have experience with soft contact lenses and spectacles wear. Children who can apply and remove soft contact lenses and spectacle glasses.
What does the study involve?
The participants will attend the visit wearing their glasses or contact lenses. The visits are expected to take approximately 24 weeks, including initial and follow-up visits. 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
• First 12 weeks
- Collection and fitting
- Compliance and wear assessment
- Vision
. Second 12 weeks
- Collection and fitting
- Compliance and wear assessment
- Vision
. 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?
October 2025 to October 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
The University of Manchester, Dover St.
Manchester
M13 9PL
United Kingdom
| Phone | +44 (0)161 306 4441 |
|---|---|
| philip.morgan@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, Hamshire
PO15 5RL
United Kingdom
| Phone | +447974858818 |
|---|---|
| Archana.Binod-Nair@coopervision.co.uk |
Study information
| Study design | Randomized bilateral 12-week crossover study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Home, Other therapist office |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Clinical investigation of myopia control contact lenses and spectacles in children |
| Study acronym | CIMCCLSC |
| Study objectives | The objective of this study is to compare the clinical performance, safety, and subjective acceptance of myopia control soft contact lenses and myopia control spectacles in young myopes. |
| Ethics approval(s) |
Approved 01/09/2025, University Research Ethics Committee 3 (Research Governance, Ethics and Integrity, 2nd Floor Christie Building, The University of Manchester, Oxford Road, Manchester, M13 9PL, United Kingdom; +44 (0) 161-306-6000; urec3@manchester.ac.uk), ref: 2025-23893-4348 4 |
| Health condition(s) or problem(s) studied | Myopia |
| Intervention | The study will be a randomized, bilateral, 12-week crossover study comparing myopic control soft daily disposable contact lenses and spectacles in myopic children. Block randomization will be computer-generated based on maximum enrollment numbers. Participants will be assigned a participant ID, and this number will be linked to the randomization assignment. After subjects are enrolled in the study, they will be randomized into two groups (Contact Lenses and Spectacles). They will be followed at the following time points: 1, 4 and 12 weeks. After 12 weeks, they will cross over to the other treatment group ( Spectacles and Contact Lenses) and will be followed up for the same period of time prior to study exit. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Omafilcon A 1-day contact lenses |
| Primary outcome measure | Intervention preference between spectacles versus contact lenses will be measured by asking subjects to provide their overall preferred intervention and the reasons for their choice using a 5-point Likert scale at the 12-week timepoint. In addition, where a participant selects the neutral option, a follow-up question will be asked to “force” them to decide. Reasons for their choice will also be collected. |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/09/2025 |
| Completion date | 01/10/2026 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Child |
| Lower age limit | 8 Years |
| Upper age limit | 12 Years |
| Sex | Both |
| Target number of participants | 55 |
| Total final enrolment | 47 |
| Key inclusion criteria | To be enrolled, each participant shall meet the following criteria: 1. Age 8 to 12 years 2. They have no previous experience with 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 5. They are willing and able to follow the protocol |
| Key exclusion criteria | The following are specific criteria that exclude a candidate from enrolment in this study: 1. Ocular disorder that would normally contraindicate contact lens wear 2. Corneal refractive surgery or have an irregular cornea 3. Use of systemic or ocular medication that would contraindicate contact lens wear 4. Candidate is aphakic 5. Participation in a contact lens or lens care product trial in the previous 30 days |
| Date of first enrolment | 24/10/2025 |
| Date of final enrolment | 01/10/2026 |
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, Hampshire
PO15 5RL
England
United Kingdom
| Phone | +44 (0)1489 883000 |
|---|---|
| jvega2@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 | 01/10/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository, Not expected to be made available |
| 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
13/10/2025: Study's existence confirmed by the University of Manchester, University Research Ethics Committee 3, UK.
