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

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mahidol University
• Treatments: Cyclosporine; Cyclosporins; Ophthalmic Solutions; Tetrahydrozoline

Criteria

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