Evaluation of the clinical acceptance of soft contact lenses for shortsightedness in adolescents
| ISRCTN | ISRCTN10586055 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10586055 |
| IRAS number | 266562 |
| Secondary identifying numbers | CV19-40 ID19-21, IRAS 266562 |
- Submission date
- 10/12/2020
- Registration date
- 28/01/2021
- Last edited
- 21/07/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
The number of adolescents with myopia (short sightedness) has been increasing very rapidly over the last 10 - 20 years. The concern is that short-sighted eyes are more likely to develop ocular pathology (eye disease) than normal eyes from the age of 60+. Therefore various methods are being developed to minimise short sightedness and prevent the potential problems later in life.
Studies to control the progression of myopia (increase in short-sightedness) are long-term studies lasting 3-5 years. The effectiveness of the contact lens in controlling myopia depends on the adolescent wearing the contact lens as long as possible everyday. The aim of this study is to test the visual acceptance of the prototype contact lens in the short term as a screening to their possibility of being used in a long-term study.
Who can participate?
Adolescents between the ages of 10 and 16 who require contact lenses
What does the study involve?
Three soft contact lenses will be worn in turn for 1 week by each participant in a random order. Each participant attends the clinic on five occasions: the first visit for enrolment, screening and fitting and the other four visits for contact lens dispensing and follow up measurements.
What are the possible benefits and risks of participating?
The participant can try using contact lenses to control their myopia.
Where is the study run from?
Ocular Technology Group - International Research Clinic (UK)
When is the study starting from and how long is it expected to run for?
March 2019 to September 2020
Who is funding the study?
CooperVision Inc (USA)
Who is the main contact?
Deborah Moore
dmoore@otg.co.uk
Contact information
Public
66 Buckingham Gate
London
SW1E 6AU
United Kingdom
| Phone | +44 (0)207 222 4224 |
|---|---|
| dmoore@otg.co.uk |
Study information
| Study design | Prospective double-masked single-group randomized cross over study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Evaluation of the clinical acceptance of soft contact lenses for myopia control |
| Study objectives | Visual satisfaction with a test contact lens is not inferior to the control contact lens. |
| Ethics approval(s) | Approved 10/07/2019, West of Scotland REC 4 (Ward 11 Dykebar Hospital, Grahamston Road, Paisley, PA2 7DE, Scotland, UK; +44 (0)141 314 0214; WoSREC4@ggc.scot.nhs.uk), REC ref: 19/WS/0099 |
| Health condition(s) or problem(s) studied | Myopia |
| Intervention | Randomisation is carried out by a standard computer randomisation generator software. Three soft contact lenses (Eni Eye Q Multifocal Contact Lenses for Daily Wear XT1, XT2 and XTC) will be worn in turn for 1 week by each participant in a random order. Each participant attends the clinic on five occasions: the first visit for enrolment, screening and fitting and the other four visits for contact lens dispensing and follow up measurements. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | Visual satisfaction measured using the mean of three questions each recorded on a 0 -100 visual analogue scale at each visit (baseline, V1 dispense, V2 10 +/- 3 days later, V3 10 +/- 3 days later, V4 10 +/- 3 days later) |
| Secondary outcome measures | Visual acuity measured using high and low LogMar visual acuity charts at a distance of 4 metres during each visit (baseline, V1 dispense, V2 10 +/- 3 days later, V3 10 +/- 3 days later, V4 10 +/- 3 days later) |
| Overall study start date | 01/03/2019 |
| Completion date | 30/09/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 10 Years |
| Upper age limit | 16 Years |
| Sex | Both |
| Target number of participants | 30 |
| Total final enrolment | 20 |
| Key inclusion criteria | 1. Age 10 to 16 years 2. Spectacle refraction: -0.75 to -6.00D spherical equivalent, maximum anisometropia 1.25D, cylinder up to -1.00DC 3. Best corrected visual acuity of at least 20/25 in each eye 4. Parents/guardians and participant have read and understood the Participant Information Sheet 5. Parents/guardians and participant have read, signed and dated the Informed Consent 6. Have normal eyes with the exception of the need for visual correction 7. Be willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment schedule |
| Key exclusion criteria | 1. Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear 2. Newly prescribed use of some systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator 3. Monocular participants (only one eye with functional vision) or participants fit with only one lens 4. Subjects with slit-lamp findings greater than grade 1 (e.g. edema, infiltrates, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival, anterior segment inflammation) as per ISO 11980, any previous history or signs of a contact lens related corneal inflammatory event (past corneal ulcers), or any other ocular abnormality that may contraindicate contact lens wear at the enrolment visit 5. History of herpetic keratitis, ocular surgery or irregular cornea 6. Enrolment of the family members of the investigator, family members of the investigator’s staff, or individuals living in the households of these individuals |
| Date of first enrolment | 01/11/2019 |
| Date of final enrolment | 01/12/2020 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
London
SW1E 6AU
United Kingdom
Sponsor information
Industry
6150 Stoneridge Mall Road
Pleasanton
94588
United States of America
| Phone | +1 (0)925 251 6682 |
|---|---|
| pchamberlain@coopervision.com | |
| Website | http://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 | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | There are no specific plans for publication or dissemination of the study results. Additional documents are not available. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 28/01/2021 | 21/07/2021 | No | No | |
| HRA research summary | 28/06/2023 | No | No |
Additional files
Editorial Notes
21/07/2021: Internal review.
28/01/2021: The basic results of this trial have been uploaded as an additional file.
27/01/2021: Trial's existence confirmed by West of Scotland REC 4.
