Dry Eye
Conditions
Keywords
dry eye
Brief summary
To compare the efficacy, safety and tolerability of 0.05% topical cyclosporin eye drop to Refresh in moderate to severe dry eye patients. Null hypothesis is: there is no difference between these two groups.
Detailed description
Inclusion criteria: 1. Participants are moderate to severe dry eye patients aged more than 18 years of age 2. Oxford staining scores of more than five. 3. OSDI scores of more than 0.1 Outcome measurements: Main parameter is staining score (corneal + conjunctival) Other parameter is OSDI score, symptom of ocular surface discomfort score, number of daily artificial tear needed, TBUT, Schirmer I score, cytokines level & markers Safety parameters: VA, IOP, cyclosporin level
Interventions
bid dosage for 4 months
Sponsors
Allergan
Chulalongkorn University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* moderate to severe dry eye
Exclusion criteria
* lid anomaly, previous CsA use
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Corneal and conjunctival staining score | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Schirmer 1 score | 1 year |
Countries
Thailand
Contacts
Primary ContactVilavun Puangsricharern, MD
Backup ContactAnyanee Charoensri, MD
Outcome results
None listed