Contact lens safety and performance study
| ISRCTN | ISRCTN14700465 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14700465 |
| IRAS number | 327576 |
| Secondary identifying numbers | ID23-05 CV23-24, IRAS 327576 |
- Submission date
- 29/08/2023
- Registration date
- 30/08/2023
- Last edited
- 30/08/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
Comfilcon A contact lenses are CE marked and have been on the European and UK markets under the name of Biofinity® or an alternate private label. Comfilcon A contact lenses are CE-marked for both daily and overnight wear of up to 7 days for use by children and adults. The intent of this study is to collect safety and performance data in current Biofinity wearers as post-market clinical follow-up and also collect data on long-term wearers in a real-world setting. The study is an observational study of long-term wearers of comfilcon A contact lenses with at least 12 months of wear. Potential participants will be identified in practices in London and the southeast who currently fit Comfilcon A contact lenses. The practices will make the initial contact with potential participants and if interested and agreeable they will send contact information to Ocular Technology Group – International (OTG-i). OTG-i will give potential participants greater details of the study and schedule the study visit if it is the wish of the potential participant.
Who can participate:
Contact lens wearers aged 8-75 years
What does the study involve?
The potential participant will attend the clinic for one study visit wearing the study contact lenses and having worn the study contact lenses for at least 3 hours that day. The visit will be about 2 hours long during which participants will be consented to participate in the study, complete a questionnaire, have their vision measured, the contact lens fit evaluated and their eyes examined. In addition, the investigator will review participant clinical notes available at the practice site to ensure that they identify any adverse event associated with wearing comfilcon A contact lenses that may have occurred are identified and analysed.
What are the possible benefits and risks of participating?
There might not be direct benefits to the participants in this study. However, participation in the study will contribute to added information on the performance and safety of the comfilcon A family of contact lenses used by a large number of contact lens wearers as their modality of vision correction.
No significant risk is associated with taking part in the study. All the assessments are routine clinical procedures, and none present any increased risks to participants compared with normal clinical routine. The study is an observation study of the participants wearing their habitual contact lenses during a single clinic visit.
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?
November 2022 to August 2025
Who is funding the study?
CooperVision International Limited (UK)
Who is the main contact?
Deborah Moore, DMoore@otg.co.uk
Contact information
Public
OTGi
66 Buckingham Gate
London
SW1E 6AU
United Kingdom
| Phone | +44 (0)207 222 4224 |
|---|---|
| dmoore@otg.co.uk |
Study information
| Study design | Single-arm observational population study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Population study |
| Study setting(s) | Other |
| Study type | Efficacy |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Comfilcon A contact lenses medical device regulation study |
| Study objectives | The primary efficacy hypothesis is that the binocular visual performance of comfilcon A contact lenses is non-inferior to that of the equivalent spectacle correction. The primary safety hypothesis is that the frequency of serious and significant adverse events is non-inferior (not greater) than the accepted frequency for extended-wear contact lenses (8.3% overall). |
| Ethics approval(s) |
Approved 09/06/2023, London - Riverside Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)20 7104 8150; riverside.rec@hra.nhs.uk), ref: 23/PR/0414 |
| Health condition(s) or problem(s) studied | Presbyopia, myopia, hyperopia, astigmatism |
| Intervention | The potential participant will attend the clinic for one study visit wearing the study contact lenses and having worn the study contact lenses for at least 3 hours that day. The visit will be about 2 hours long during which participants will be consented to participate in the study, complete a questionnaire, have their vision measured, the contact lens fit evaluated and their eyes examined. In addition, the investigator will review participant clinical notes available at the practice site to ensure that they identify any adverse event associated with wearing comfilcon A contact lenses that may have occurred are identified and analysed. The acceptance and performance of the contact lenses will be tested for efficacy as per ISO11980-2012: 1. Measurement of contact lens logMAR visual acuity 2. Subjective rating of comfort, vision and handling 3. Subjective rating of contact lens fit and contact lens surface characteristics The performance will be tested for safety as per ISO11980-2012 [3]: 1. Identification of ocular adverse events related to contact lens wear 2. Measurement of spectacle logMAR visual acuity 3. Assessment of the ocular tissues and ratings as per ISO11980-2012 scales Population profiling will use the following procedures: 1. Demographics and medical and ocular history 2. Contact lens-wearing characteristics 3. Manifest spectacle refraction (sphero-cylinder) 4. Keratometry |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Comfilcon A Contact Lenses |
| Primary outcome measure | logMAR photopic (200 cd/m2) high contrast (>90%) visual acuity at distance (400 cm) and near (40 cm) measured to the nearest letter, measured at a single timepoint during the visit |
| Secondary outcome measures | 1. Comfort recorded on a six-point scale, measured at a single timepoint during the visit 2. Vision recorded on a six-point scale, measured at a single timepoint during the visit 3. Handling recorded on a six-point scale, measured at a single timepoint during the visit |
| Overall study start date | 20/11/2022 |
| Completion date | 15/08/2025 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Mixed |
| Lower age limit | 8 Years |
| Upper age limit | 75 Years |
| Sex | Both |
| Target number of participants | 182 |
| Key inclusion criteria | 1. Contact lens wearers using comfilcon A family of contact lenses comprising Biofinity® and private label, sphere, toric, multifocal, toric multifocal 2. Age 8-75 years 3. Current wearer of one of the above contact lens types for at least 12 months managed by referring practice 4. At least occasional overnight wear in the last 12 months 5. Be willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment scheduled at OTG-i |
| Key exclusion criteria | Current participation of the subject in a contact lens or contact lens care product clinical trial |
| Date of first enrolment | 18/08/2023 |
| Date of final enrolment | 01/08/2025 |
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
England
United Kingdom
| Phone | +44 (0)238 0247105 |
|---|---|
| krichdale@coopervision.com | |
| Website | https://cooper vision.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/12/2025 |
|---|---|
| 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 | Not known as yet |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Editorial Notes
30/08/2023: Study's existence confirmed by the London - Riverside Research Ethics Committee.
