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

Phase 4

Completed

• Conditions: Meibomian Gland Dysfunction
• Interventions: Drug: 0.05% cyclosporin eye drop

• Registration Number: NCT00705510
• Lead Sponsor: Mahidol University

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.

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-06-24
• Study First Submitted QC: 2008-06-25
• Study First Posted: 2008-06-26
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-08
• Last Update Posted: 2010-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	0.05% cyclosporin eye drop	-
B	0.05% cyclosporin eye drop	-

Primary Outcome Measures

Name	Time	Method
NTBUT	0,1,2,3 month

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Ophthalmology; Siriraj Hospital; 🇹🇭 Bangkok, Thailand