Clinical acceptance and performance of Hercules soft contact lenses
| ISRCTN | ISRCTN67481469 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67481469 |
| IRAS number | 296709 |
| Secondary identifying numbers | CV20-32 ID20-67, IRAS 296709 |
- Submission date
- 09/06/2021
- Registration date
- 11/06/2021
- Last edited
- 27/04/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English Summary
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 and satisfaction of the contact lenses.
Who can participate?
Adolescents between the ages of 10 and 18 that require contact lenses.
What does the study involve?
Participants will attend the clinic on three separate days approximately one week apart. Two different soft contact lenses will be dispensed at visit 1 and 2 and at visits 2 and 3, participants' vision and satisfaction will be measured by the investigators.
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?
Ocular Technology Group - International Research Clinic (UK)
When is the study starting and how long is it expecting to run for?
June 2021 to November 2021
Who is funding the study?
CooperVision International Limited (UK)
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 | Single-centre prospective double-masked randomized crossover trial |
|---|---|
| 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 contact details to request a participant information sheet. |
| Scientific title | Validation study of the clinical acceptance and performance of Hercules soft contact lenses |
| Study hypothesis | 1. Overall visual acuity performance with the Test contact lens is not statistically inferior to the Control contact lens after one week of wear 2. Comfort and wearing time with the Test contact lens is not statistically inferior to the Control contact lens after one week of wear |
| Ethics approval(s) | Approved 17/05/2021, Yorkshire & The Humber, Leeds West Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ, UK; +44(0)207 972 2504; leedswest.rec@hra.nhs.uk) ref: 21/YH/0074 |
| Condition | Clinical acceptance and performance of soft contact lenses |
| Intervention | Randomisation is carried out by a standard computer randomisation generator software. Two soft contact lenses will be worn by each participant in a random order in turn for 1 week on a daily disposable basis. Each participant attends the clinic on three occasions: the first visit for enrolment, screening and contact lens order 1 dispense, visit 2 for contact lens order 1 follow-up and contact lens order 2 dispense, and visit 3 for contact lens order 2 follow-up and discharge. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | MiSight® 1 day daily disposable contact lenses |
| Primary outcome measure | Overall binocular visual performance (logMAR chart) measured after 9 - 13 days of wear |
| Secondary outcome measures | 1. Overall comfort on a 100-point visual analog scale measured after 9 - 13 days of wear 2. Daily wearing time in hours measured after 9 - 13 days of wear |
| Overall study start date | 01/06/2021 |
| Overall study end date | 30/11/2021 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Child |
| Lower age limit | 8 Years |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | 90 |
| Total final enrolment | 63 |
| Participant inclusion criteria | 1. Age 8 to 18 years; 2. Current soft contact lens wearers; 3. Spectacle refraction: -0.75 to -6.00D spherical equivalent, with cylinder ≤ -0.75 DC and maximum anisometropia of <1.00D; 4. Best corrected visual acuity of at least 20/25 in each eye; 5. Parents/guardians and participant have read and understood the Participant Information Sheet; 6. Parents/guardians and participant have read, signed and dated the Informed Consent; 7. Have normal eyes with the exception of the need for visual correction; 8. Be willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment schedule. |
| Participant 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. |
| Recruitment start date | 14/06/2021 |
| Recruitment end date | 01/10/2021 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
London
SW1E 6AU
United Kingdom
Sponsor information
Industry
Delta Park
Concorde Way
Segensworth North
Fareham
PO15 5RL
United Kingdom
| lhall@coopervision.com | |
| Website | http://coopervision.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/12/2021 |
|---|---|
| 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 current data sharing plans for this study are unknown and will be available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | version 1.0 | 27/04/2022 | 27/04/2022 | No | No |
| HRA research summary | 26/07/2023 | No | No |
Additional files
Editorial Notes
27/04/2022: The following changes have been made:
1. The basic results of this trial have been uploaded as an additional file.
2. The total final enrolment number has been added.
09/06/2021: Trial's existence confirmed by Yorkshire & The Humber, Leeds West Research Ethics Committee.
