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To evaluate the efficacy of 0.05% cyclosporine ophthalmic emulsion (Restasis® , Allergan) versus an artificial tears alone in patients with meibomian gland dysfunction that have abnormal tear quality and quantity by subjective symptoms and signs including tear breakup time
Meibomian gland dysfunction patients will divide into 2 groups. One group will have 0.05% cyclosporine opthalmic emulsion and the other will have non-preservative artificial tear twice daily, compare the result in 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator |
| |
| B | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.05% cyclosporin eye drop | Drug | use the medication twice daily for 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| NTBUT | 0,1,2,3 month |
| Measure | Description | Time Frame |
|---|---|---|
| OSDI score, FTBUT, lid inflammation, meibomian gland secretion and expressibility, bulbar and tarsal conjunctival injection,fluorescein staining, rose bengal staining | 0,1,2,3 month |
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Inclusion Criteria:
Males or females, of legal age of consent
Patient has a diagnosis of meibomian gland dysfunction with at least 1 symptom as the following; ocular burning, ocular discomfort, and grittiness
Had a slit-lamp diagnosis of meibomian gland dysfunction based on the presence of one of the following
Non-invasive tear break up time (NTBUT) with Tear scope Plus(Keeler, Windsor, UK) ≤ 8 seconds
Ability to follow study instruction and likely to complete all required visits
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pinnita Prabhasawat, MD | Department of Ophthalmology, Siriraj H, Mahidol U | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Ophthalmology; Siriraj Hospital | Bangkok | Bangkok | 10700 | Thailand |
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| ID | Term |
|---|---|
| D000080343 | Meibomian Gland Dysfunction |
| ID | Term |
|---|---|
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
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