Bilateral dry eye syndrome/ophthalmology Eye Diseases Disorders of lacrimal system
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Signed informed consent 2. Male and female patients aged 21 years and over 3. Diagnosis of dry eye syndrome refractory to conventional management 4. Schirmer test (without anaesthesia) was less than 5 mm/5 minutes in at least one eye 5. Low tear film break-up time (tBUT) (less than 5 seconds) 6. Mild superficial punctate keratitis, defined as a corneal punctate fluorescein staining score of greater than or equal to 1 in either eye (scale 0 [none] to 3 [severe]) 7. Symptoms of ocular irritation as assessed by an Ocular Surface Disease Index (OSDI) score of 25 or greater (on a scale of 0 - 59)
Exclusion criteria
Exclusion criteria: 1. History of any ocular disorder including injury 2. Ocular infection 3. Non-dry eye ocular inflammation 4. Ocular trauma 5.Ocular surgery within the prior 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Symptom scoring 2. Tear film BUT 3. Schirmer test (without anaesthesia) 4. Corneal fluorescein staining 5. Conjunctival impression cytologic analysis All performed before treatment, and at first, second and third months after initiation of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Goblet cell density, assessed before treatment, and at first, second and third months after initiation of treatment. | — |
Countries
Korea, South