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Sensitivity of the front part of the eye and its association with dry eye

Corneal sensitivity demographics and its association with dry eye

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN13906640
Enrollment
120
Registered
2022-09-15
Start date
2022-08-01
Completion date
Unknown
Last updated
2023-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non contact lens wearers that suffer from dry eye Eye Diseases

Interventions

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 cal

Sponsors

CooperVision International Ltd
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Extent of ocular symptoms measured by an OSDI questionnaire.

Countries

England, United Kingdom

Contacts

Public ContactDeborah Moore
dmoore@otg.co.uk+44 2072224224

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026