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

Meibomian Gland Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00705510
• Other study ID #: 154/2551(EC1)
• Status: Completed
• Phase: Phase 4
• First received: June 24, 2008
• Last updated: November 8, 2010
• Start date: May 2008
• Est. completion date: October 2010

Study information

• Verified date: November 2010
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Meibomian Gland Dysfunction

Intervention

Drug:
• 0.05% cyclosporin eye drop
use the medication twice daily for 3 months

Locations

Country	Name	City	State
Thailand	Department of Ophthalmology; Siriraj Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NTBUT		0,1,2,3 month	Yes
Secondary	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	Yes