Dry eye Eye Diseases Other disorders of lacrimal gland
Conditions
Interventions
Participants are randomised 1:1:1 by random number generation to one of three groups (the researcher who tests the patients will not know whether they belong to the study group A, study group B, or co
Sponsors
Cathedral Eye Research
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 or over 2. Have otherwise healthy eyes 3. Are prepared not to wear contact lens for 3 months of the trial 4. Have a NITBUT <10s 5. OSDI score: greater than or equal to 12 6. Symptom frequency at least "some of the time" 7. Presence of cloudy fluid expressed from at least 1 of the central 8 glands on the lower/upper lid AND/OR presence of poor expressibility from at least 2-3 of the central 8 glands on the lower lid
Exclusion criteria
Exclusion criteria: 1. Conjunctivitis 2. Meibomian cysts 3. Styes 4. Damage to the cornea 5. Ocular injury 6. Cataract or laser refractive surgery in the past 6 months 7. Increased intraocular pressure (primary or secondary) 8. Any chronic disease of the eye
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tear film lipid layer thickness for right and left eyes, measured using images captured with Tearscope at 2 weeks, 1 month, 2 months and 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured at baseline, 1 month and 3 months: 1. Tear film quality, measured as non-invasive tear break up time using a slit-lamp-mounted TearScope on each eye in random order 2. Meibomian gland function, based upon meibum quality and expressibility using a slit-lamp following firm digital pressure to the eyelid margins 3. Ocular redness/hyperaemia, measured using images captured non-invasively using a high resolution digital slit-lamp photography of the limbal and temporal conjunctiva for both eyes. Ocular surface conjunctival blood-flow will also be observed and correlated with the heart beat/pulse of the patient 4. MMP-9, an inflammatory marker in the tears of patients with dry eye disease for right and left eyes, measured using a non-invasive RPS InflammaDry Detector 5. Corneal sensitivity for right and left eyes, measured using handheld esthesiometer (Cochet-Bonnet) 6. Corneal staining for right and left eyes, assessed via instillation of lissamine green and fluorescein sodium and using the Oxford corneal grading score 7. Tear volume for right and left eyes, measured using Phenol red thread test 8. Dry eye symptoms for right and left eyes, measured using the Ocular Surface Disease Index 9. Visual satisfaction, measured with Quality of Vision (QOV) questionnaire scores 10. Longitudinal progress of the patient’s dry eye symptoms and adherence to dry eye treatment, measured with the D-III questionnaire | — |
Countries
United Kingdom
Outcome results
None listed