Testing two new methods to detect differences between contact lens materials
| ISRCTN | ISRCTN84775121 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84775121 |
| IRAS number | 335090 |
| Secondary identifying numbers | OTG-i ID23-50, IRAS 335090 |
- Submission date
- 28/11/2023
- Registration date
- 30/11/2023
- Last edited
- 04/07/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
Differences in modern contact lens acceptance, mainly differences in comfort and quality of vision, have been reported in many studies. It is thought to be due to differences in the characteristics of the different contact lens materials. However, studies using standard clinical techniques do not reveal any differences between the different materials. OTGi has developed advanced clinical techniques that may be more sensitive to detect differences between materials.
The aim of this study is to determine the precision of two OTG-i proprietary methodologies that could detect differences between contact lens materials, called in vivo de-wetting kinetics and Landolt ring timed controlled contrast sensitivity. The results of the study will make it possible to calculate future study sample sizes to measure the performance of different contact lenses.
Who can participate?
Adults aged 18 to 35 years who are current soft contact lens wearers and have low levels of astigmatism
What does the study involve?
There are three study visits, each at most 1 week apart. During the study visits, the participant will be fitted with one type of study contact lens, a set of visual measurements will be carried out and a video recording of the tear film will be made.
What are the possible benefits and risks of participating?
There might not be direct benefits to the participants in this study. However, in taking part in the study, the participants will have the opportunity to try a different contact lens type than their own contact lenses. Further, their participation in the study may contribute to scientific research information that may be used in the development of better clinical testing and/or better contact lenses.
Where is the study run from?
Ocular Technology Group - International (OTG-i) (UK)
When is the study starting and how long is it expected to run for?
July 2023 to May 2024
Who is funding the study?
Alcon Research, LLC (Switzerland)
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)20 7222 4224 |
|---|---|
| dmoore@otg.co.uk |
Scientific, Principal Investigator
66 Buckingham Gate
London
SW1E 6AU
United Kingdom
| Phone | +44 (0)207 222 4224 |
|---|---|
| mguillon@otg.co.uk |
Study information
| Study design | Prospective interventional test-re-test study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised 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 | Contact lens performance novel endpoints validation |
| Study objectives | The objective of the study will be to determine the repeatability of the two methodologies; hence, no specific hypotheses will be tested. |
| Ethics approval(s) |
Approved 01/11/2023, West Midlands - Edgbaston Research Ethics Committee (2 Redman Place, Stratford, E20 1JQ, United Kingdom; +44 (0)2071048357; edgbaston.rec@hra.nhs.uk), ref: 23/PR/1219 |
| Health condition(s) or problem(s) studied | Determination of the repeatability of OTG-i Vision Suite, Landolt ring contrast sensitivity and In vivo de-wetting kinetics |
| Intervention | Following a visit in which potential participants are screened, enrolled and familiarised with the testing procedures, participants will visit the clinic on two separate days within a 7-day period and will complete tests to evaluate their contrast sensitivity at 85 cd/m² and eye wettability at fixed timepoints. |
| Intervention type | Other |
| Primary outcome measure | 1. Post hoc analysis of tearscope digital video recording using scale percentage exposure per second, performed during visit 2 and visit 3 2. Timed letter contrast sensitivity using OTGi vision suite, the scale is in Log of contrast percentage, performed during visit 2 and visit 3 |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/07/2023 |
| Completion date | 01/05/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 35 Years |
| Sex | Both |
| Target number of participants | 25 |
| Key inclusion criteria | There are no requirements as to participant race or gender. 1. Age 18 to 35 years 2. Current daily disposable hydrogel or silicone hydrogel spherical contact lens wearer 3. Normal contact lens wearing characteristics as per Young modified questionnaire 4. Spectacle refraction: 4.1. Sphere: -6.00D to + 2.00D 4.2. Astigmatism: 0.00D to -0.75 5. Best corrected visual acuity of at least 20/25 in each eye The prospective participants will be given a Participant Information Sheet to read and an Informed Consent Form to sign prior to any evaluation. |
| Key exclusion criteria | To be eligible as a participant, each candidate shall be free of any ocular or medical condition that may affect the results of this study. The following are specific criteria that exclude a candidate from enrolment in this study: 1. Acute and subacute inflammation or infection of the anterior chamber of the eye 2. Any eye disease, injury or abnormality that affects the cornea, conjunctiva or eyelids that would contraindicate contact lens wear 3. Corneal hypoesthesia (reduced corneal sensitivity), if not aphakic 4. Severe insufficiency of lacrimal secretion (dry eyes) 5. Any systemic disease that may affect the eye or may be exaggerated by wearing contact lenses (e.g. acne and eczema) 6. Allergic reactions of ocular surfaces or adnexa that may be induced or exaggerated by wearing contact lenses or use of contact lens solutions 7. Any active corneal infection (bacterial, fungal, protozoal or viral) 8. Newly prescribed (within the past 30 days) use of some systemic medications (such as antihistamines, decongestants, diuretics, muscle relaxants, tranquilizers, stimulants, anti-depressants, anti-psychotics, oral contraceptives) or new prescription eyedrops which is not rewetting/lubricating eyedrops for which contact lens wear could be contraindicated as determined by the investigator 9. Monocular participants (only one eye with functional vision) or participants fit with only one contact lens 10. 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 11. History of corneal refractive surgery 12. 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 | 14/11/2023 |
| Date of final enrolment | 30/12/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
London
SW1E 6AU
United Kingdom
Sponsor information
Research organisation
66 Buckingham Gate
London
SW1E 6AU
England
United Kingdom
| Phone | +44 (0)20 7222 4224 |
|---|---|
| dmoore@otg.co.uk |
Funders
Funder type
Industry
Government organisation / For-profit companies (industry)
- Location
- United States of America
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 plans at this stage for publication or dissemination. |
| 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 | version 0.3 | 19/04/2024 | 04/07/2024 | No | No |
Additional files
Editorial Notes
04/07/2024: The basic results have been uploaded as an additional file.
30/11/2023: Study's existence confirmed by the West Midlands - Edgbaston Research Ethics Committee.
