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

This study has been completed.
Sponsor:
Information provided by:
Mahidol University
ClinicalTrials.gov Identifier:
NCT00705510
First received: June 24, 2008
Last updated: November 8, 2010
Last verified: November 2010
  Purpose

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


Condition Intervention Phase
Meibomian Gland Dysfunction
Drug: 0.05% cyclosporin eye drop
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of 0.05 % Cyclosporine Ophthalmic Emulsion Compare With Tear in Meibomian Gland Dysfunction

Resource links provided by NLM:


Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • NTBUT [ Time Frame: 0,1,2,3 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 70
Study Start Date: May 2008
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A Drug: 0.05% cyclosporin eye drop
use the medication twice daily for 3 months
Other Name: Restasis eye drop, Cellufresh eye drop
Placebo Comparator: B Drug: 0.05% cyclosporin eye drop
use the medication twice daily for 3 months
Other Name: Restasis eye drop, Cellufresh eye drop

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00705510

Locations
Thailand
Department of Ophthalmology; Siriraj Hospital
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Pinnita Prabhasawat, MD Department of Ophthalmology, Siriraj H, Mahidol U
  More Information

No publications provided

Responsible Party: Pinnita Prabhasawat, Department of Ophthalmology; Siriraj Hospital
ClinicalTrials.gov Identifier: NCT00705510     History of Changes
Other Study ID Numbers: 154/2551(EC1)
Study First Received: June 24, 2008
Last Updated: November 8, 2010
Health Authority: Thailand: Ethical Committee

Keywords provided by Mahidol University:
Cyclosporine
Unstable tear film
Meibomian gland
Meibomian gland dysfunction

Additional relevant MeSH terms:
Tetrahydrozoline
Cyclosporins
Cyclosporine
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Respiratory System Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on July 26, 2014