Sensitivity of the front part of the eye and its association with dry eye
| ISRCTN | ISRCTN13906640 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13906640 |
| IRAS number | 318209 |
| Secondary identifying numbers | ID22-25 CV-22-22, IRAS 318209 |
- Submission date
- 06/09/2022
- Registration date
- 15/09/2022
- Last edited
- 13/03/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
Measurement of corneal sensitivity (how sensitive the front part of your eye is) has been a marker for contact lens performance for a long time. Recent technology developments have meant we have new instruments for measuring corneal sensitivity. Recent interest has been around corneal sensitivity in dry eye sufferers. To date, there is no corneal sensitivity data available for those with varying types and extents of dry eye and so this study aims to establish population norms.
Who can participate?
Individuals ages between 18 and 75 years old that are non-contact lens wearers can take part. You also can have no history of eye surgery or eye disease (except for dry eye).
What does the study involve?
The study involves a single clinic visit in which the extent of your dry eye will be assessed and your corneal sensitivity will be measured.
What are the possible benefits and risks of participating?
There may not be any direct benefits for participating in the study, however participants will be contributing to scientific research which can be used in the care of those suffering with dry eye. The measurements in the study, except for corneal sensitivity measurement, are routine clinical procedures and so present no more risk to patients than their own primary eye care. The measurement of corneal sensitivity is non-invasive using well-established technology. Participants will be under the care of the investigator while they are active in the study and the health of their eyes will be checked at the start and end of the study to ensure their vision and eye health is unchanged.
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?
March 2022 to December 2022
Who is funding the study?
CooperVision International Ltd. (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 2072224224 |
|---|---|
| dmoore@otg.co.uk |
Study information
| Study design | Single centre observational double masked single group study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Other |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Corneal sensitivity demographics and its association with dry eye |
| Study objectives | No formal hypotheses will be formulated for this study. But the following questions will be addressed separately: i. What are the corneal sensitivity characteristics of symptomatic and asymptomatic patients? ii. What are the corneal sensitivity characteristics of symptomatic patients with signs of aqueous deficient dry eyes? iii. What are the corneal sensitivity characteristics of symptomatic patients with signs of evaporative dry eyes? iv. What are the corneal sensitivity characteristics of symptomatic patients with signs of mixed dry eyes? v. What are the corneal sensitivity characteristics of three categories of dry eye sufferers (i. asymptomatic with signs of dry eyes; ii. symptomatic without signs of dry eye and iii. symptomatic with signs of dry eyes)? |
| Ethics approval(s) | Approved 02/08/2022, West Midlands - South Birmingham Research Ethics Committee (Equinox House, City Link, Nottingham, NG2 4LA, UK; +44 (0)207 1048345; southnirmingham.rec@hra.nhs.uk), ref: 22/WM/0179 |
| Health condition(s) or problem(s) studied | Non contact lens wearers that suffer from dry eye |
| Intervention | Participants will complete a dry eye evaluation by a qualified optometrist and also answer some questions about their dry eye. They will then have their corneal sensitivity assessed using a device called an aesthesiometer. |
| Intervention type | Other |
| Primary outcome measure | Corneal sensitivity is measured by the point at which a participant detects a light puff of air on their cornea. There are no defined time points for the measurement. |
| Secondary outcome measures | Extent of ocular symptoms measured by an OSDI questionnaire. |
| Overall study start date | 01/03/2022 |
| Completion date | 07/12/2022 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 120 |
| Key inclusion criteria | 1. Age 18 to 75 years; 2. No contact lens wear in the past 5 years. 3. Non-contact lens wearers divided into three groups based upon symptomatology: 3.1. Asymptomatic OSDI ≤ 9.0 points 3.2. Symptomatic slight to mild OSDI >9.0 points & ≤ 33.0 points 3.3. Symptomatic moderate to severe > 33 points 4. Best corrected visual acuity of at least 20/30 in each eye; 5. No history of eye surgery or ocular disease (except for dry eye) 6. No history of medical conditions which, in the investigator’s opinion, could impact ocular symptoms or corneal sensitivity. Examples include diabetes and autoimmune diseases. 7. No history of systemic or topical medication (except for artificial tears) which, in the investigator’s opinion, could impact symptoms or corneal sensitivity. Examples include acne medication, anti-inflammatory medication and/or dry eye medication; 8. Have read and understood the Participant Information Sheet in English; 9. Have read, signed and dated the Informed Consent. |
| Key exclusion criteria | 1. Ocular anterior segment infection, inflammation, abnormality, or active disease; 2. Monocular participants (only one eye with functional vision); 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; 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. |
| Date of first enrolment | 01/08/2022 |
| Date of final enrolment | 04/12/2022 |
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 | +1 (0)925 251 6768 |
|---|---|
| sbasuthkar@coopervision.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/01/2024 |
|---|---|
| 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 and dissemination in a public archive. |
| 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 1.0 | 07/03/2023 | 13/03/2023 | No | No |
| HRA research summary | 28/06/2023 | No | No |
Additional files
Editorial Notes
13/03/2023: Internal review.
08/03/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/11/2023 to 04/12/2022.
2. The overall end date was changed from 01/12/2023 to 07/12/2022.
3. The plain English summary was updated to reflect these changes.
07/03/2023: The basic results have been uploaded as an additional file.
07/09/2022: Trial's existence confirmed by West Midlands - South Birmingham Research Ethics Committee
