Skip to main content
OpenTrials
Completed

NCT Number: NCT00705510

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Ophthalmology; Siriraj Hospital

Bangkok, 10700, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

0.05% cyclosporin eye drop

Drug

use the medication twice daily for 3 months

Other names: Restasis eye drop, Cellufresh eye drop

Primary outcomes

  1. NTBUT

    Time frame: 0,1,2,3 month

Secondary outcomes

  1. OSDI score, FTBUT, lid inflammation, meibomian gland secretion and expressibility, bulbar and tarsal conjunctival injection,fluorescein staining, rose bengal staining

    Time frame: 0,1,2,3 month

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jun 26, 2008
Registry last updated
Nov 9, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.