Status:
COMPLETED
Efficacy of 0.05 % Cyclosporine Ophthalmic Emulsion Compare With Tear in Meibomian Gland Dysfunction
Lead Sponsor:
Mahidol University
Conditions:
Meibomian Gland Dysfunction
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00705510
Start Date
May 1 2008
End Date
October 1 2010
Last Update
November 9 2010
Active Locations (1)
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1
Department of Ophthalmology; Siriraj Hospital
Bangkok, Bangkok, Thailand, 10700