Proactive management to understand contact lens wearers success
| ISRCTN | ISRCTN11525595 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11525595 |
| IRAS number | 266960 |
| Secondary identifying numbers | CV19-55 ID19-23, IRAS 266960 |
- Submission date
- 10/12/2020
- Registration date
- 28/01/2021
- Last edited
- 20/07/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
Contact lenses are small prescription lenses, worn in "contact" with the eye. They are designed to correct eyesight and maintain eye health.
Up to 50% of contact lens wearers report discomfort hence it is important to try to find better ways to manage their contact lenses to improve their comfort. The aim will be to test if by increasing management over routine practice results in the wearer having a greater comfort.
Who can participate?
Soft contact lens wearers complaining of discomfort aged 18 to 40.
What does the study involve?
The study involves 5 visits. At the first visit, the participants are screened, enrolled and fitted with the contact lenses and dispensed with their management protocol. At the other 4 visits (1, 3, 6 and 12 months), the participants are monitored to quantify any improvement from baseline. Also, the participant will complete electronic questionnaires monthly to track their progress.
What are the possible benefits and risks of participating?
The benefits to the participant are the opportunity to try a different contact lens and or those in the test group to have increased management to solve their contact lens comfort problems than they would have in routine practice. There are no increased risks, the contact lenses and management system are all using CE marked products.
Where is the study run from?
Ocular Technology Group - International (UK)
When is the study starting and how long is it expected to run for?
July 2019 to May 2021
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 2224224 |
|---|---|
| dmoore@otg.co.uk |
Study information
| Study design | Early feasibility prospective single masked open label randomized parallel-group |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Understanding the impact of proactive management to improve symptomatic contact lens wearers success |
| Study objectives | Symptomatic contact lens wearers are refitted with a standard daily disposable contact lens, those who are proactively managed will experience lesser symptoms and longer comfortable wearing time than those who are managed by following a standard management routine. |
| Ethics approval(s) | Approved 06/08/2019, Yorkshire & The Humber - Bradford Leeds Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ, UK; +44 (0)207 1048 088; nrescommittee.yorkandhumber-bradfordleeds@nhs.net), ref: 19/YH/0245 |
| Health condition(s) or problem(s) studied | Management of soft contact lens wearing symptoms |
| Intervention | The participants were refitted with a daily disposable contact lens, half in the control group were managed as per conventional routine practice and the other half in the test group received enhanced management. The randomisation process was a 1:1 randomisation using a computerised program. The study involves 5 visits. At the first visit, the participants are screened, enrolled and fitted with the contact lenses and dispensed with their management protocol. At the other 4 visits (1, 3, 6 and 12 months), the participants are monitored to quantify any improvement from baseline. Also, the participant will complete electronic questionnaires monthly to track their progress. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Contact lens overall comfort measured using the CLDEQ8 questionnaire overall score at 1, 3, 6 and 12 months 2. Contact lens wearing time (hours) measured using self report at 1, 3, 6 and 12 months |
| Secondary outcome measures | Contact lens comfort at different times of the day measured using 100 point Visual Analogue scale at 1, 3, 6 and 12 months |
| Overall study start date | 01/07/2019 |
| Completion date | 01/05/2021 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 90 |
| Total final enrolment | 81 |
| Key inclusion criteria | 1. Age 18 to 40 years 2. Current daily wear soft contact lens wearer who have worn contact lenses for at least six months in total 3. CLDEQ-8 ≥14 and/or comfortable wearing time ≤ 9hrs; with selfreported end of day dryness or discomfort 4. Spectacle refraction: Sphere: -6.00D to + 4.00D Astigmatism: 0.00D to -0.75 5. Best corrected visual acuity of at least 20/30 in each eye 6. No significant ocular signs that would prohibit contact lens wear including: 6.1. Blepharitis score <3 (0 to 4-point scale) 6.2. Meibomian gland score <3 (0 to 4-point scale) 6.3. Corneal staining score <7 (0 to 10-point scale) 6.4. Conjunctival staining score <3 on (0 to 4-point scale) 6.5. TPH without contact lenses ≥0.125 mm 6.6. OSDI score without contact lenses <13 7. Have read and understood the Participant Information Sheet in English 8. Have read, signed and dated the Informed Consent 9. Have normal eyes with the exception of the need for visual correction 10. 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. Monocular participants (only one eye with functional vision) or participants fit with only one lens 3. Any moderate or severe ocular condition observed during the slit-lamp examination at the enrolment visit 4. History of herpetic keratitis, ocular surgery or irregular cornea 5. Known pregnancy or lactation during the study period as determined by self-report 6. Enrolment of the investigator or his/her staff, family members of the investigator, family members of the investigator’s staff, or individuals living in the households of these individuals 7. Individuals who are unable to read or understand the Participant Information Sheet in English |
| Date of first enrolment | 01/08/2019 |
| Date of final enrolment | 23/12/2020 |
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 | +1 925 251 6682 |
|---|---|
| nkeir@coopervision.com | |
| Website | http://coopervision.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/07/2022 |
|---|---|
| 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. |
| 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 v0.1 | 20/07/2021 | No | No | |
| HRA research summary | 28/06/2023 | No | No |
Additional files
Editorial Notes
20/07/2021: The basic results of this trial have been uploaded. Total final enrolment number added.
28/01/2021: Trial’s existence confirmed by Yorkshire & The Humber - Bradford Leeds Research Ethics Committee.
