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

Mahidol University

Status and phase: Completed; Phase 4

Conditions: Meibomian Gland Dysfunction

Treatments: Drug: 0.05% cyclosporin eye drop

Study type: Interventional

Funder types: Other

Identifiers

NCT00705510

154/2551(EC1)

Details and patient eligibility

About

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

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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70 participants in 2 patient groups, including a placebo group

A

Active Comparator group

Treatment:

Drug: 0.05% cyclosporin eye drop

B

Placebo Comparator group

Treatment:

Drug: 0.05% cyclosporin eye drop