Efficacy of 0.05 % Cyclosporine Ophthalmic Emulsion Compare With Tear in Meibomian Gland Dysfunction

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Efficacy of 0.05 % Cyclosporine Ophthalmic Emulsion Compare With Tear in Meibomian Gland Dysfunction

Conditions
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Meibomian Gland Dysfunction

Intervention / Treatment
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* Drug: 0.05% cyclosporin eye drop


Participation Criteria
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Eligibility Criteria
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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 meibomian gland inflammation by lid margin or tarsal erythema, bulbar conjunctiva hyperemia, telangiectasia or thickening irregularity of the eyelid margins meibomian gland orifice inclusion (plugging) or abnormal of secretion 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: Age < 18 years old Patients with severe ocular disease from Steven Johnson syndrome burn, limbal deficiency Patients used cyclosporine within past 1 year Patients used oral cyclosporine or anticholinergic drug within past 2 months Patients with HIV or autoimmune disease Patients with active ocular infections and patients with a history of herpes keratitis Patients with known or suspected hypersensitivity to any of the ingredients in the formula (cyclosporine, glycerin, castor oil, polysorbate 80, carbomer 1342) Female patients are pregnant or nursing Patients who wear contact lenses

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br> | Drug: 0.05% cyclosporin eye drop<br>* use the medication twice daily for 3 months<br>* Other names: Restasis eye drop, Cellufresh eye drop;|
| Placebo Comparator: B<br> | Drug: 0.05% cyclosporin eye drop<br>* use the medication twice daily for 3 months<br>* Other names: Restasis eye drop, Cellufresh eye drop;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NTBUT |  | 0,1,2,3 month | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cyclosporine, Unstable tear film, Meibomian gland, Meibomian gland dysfunction