Meibomian Gland Dysfunction
Conditions
Keywords
Cyclosporine, Unstable tear film, Meibomian gland, Meibomian gland dysfunction
Brief summary
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
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.
Interventions
use the medication twice daily for 3 months
Sponsors
Mahidol 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 No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NTBUT | 0,1,2,3 month |
Secondary
| Measure | 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 |
Countries
Thailand
Outcome results
None listed