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

Not Applicable

Completed

• Conditions: on contact lens wearers that suffer from dry eye; Eye Diseases

• Registration Number: ISRCTN13906640
• Lead Sponsor: CooperVision International Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-09-15
• Study Completion: 2022-12-07
• Last Update Posted: 27 March 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

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

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified