Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Allergan | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Inclusion criteria:
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
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | 0.05% cyclosporin |
|
| B | Active Comparator | Refresh |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.05% cyclosporin eye drop | Drug | bid dosage for 4 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Corneal and conjunctival staining score | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Schirmer 1 score | 1 year |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vilavun Puangsricharern, MD | Contact | 66-2256-4424 | vilavun@hotmail.com | |
| Anyanee Charoensri, MD | Contact | 66-8464-70202 | anyaneeam@yahoo.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OPD Chulalongkorn University Hospital | Active, not recruiting | Bangkok | 10330 | Thailand | ||
Not provided
Not provided
Not provided
Not provided
Not provided
| OPD Chulalongkorn University Hospital |
| Recruiting |
| Bangkok |
| Thailand |
|
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided