Efficacy of 0.05 % Cyclosporine Ophthalmic Emulsion Compare With Tear in Meibomain Gland Dysfunction - Full Text View

Sponsored by:	Mahidol University
Information provided by:	Mahidol University
ClinicalTrials.gov Identifier:	NCT00705510

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 IV

Drug Information available for: Cyclosporin Cyclosporine Tetrahydrozoline Tetrahydrozoline hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Efficacy of 0.05 % Cyclosporine Ophthalmic Emulsion Compare With Tear in Meibomain Gland Dysfunction

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, TBUT, fluorescein staining, rose bengal staining, meibomian gland [ Time Frame: 0,1,2,3 month ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	74
Study Start Date:	May 2008
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator	Drug: 0.05% cyclosporin eye drop use the medication twice daily for 3 months
B: Placebo Comparator	Drug: 0.05% cyclosporin eye drop use the medication twice daily for 3 months

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 placebo eye drop 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, talengiectasia 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 (cyclospolrine, glycerin, castor oil, polysorbate 80, carbomer 1342)
Female patients are pregnant or nursing
Patients who wear contact lenses

Contacts and Locations

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

Contacts

Contact: Pinnita Prabhasawat, MD	662-419-7000 ext 8033	sippb@mahidol.ac.th
Contact: Wannaree Mahawong, MD	662-419-7000 ext 8033	pooh_pu@hotmail.com

Locations

Thailand
Department of Ophthalmology; Siriraj Hospital	Recruiting
Bangkok, Thailand, 10700
Contact: Pinnita Prabhasawat, MD 662-419-7000 ext 8033 sippb@mahidol.ac.th
Contact: Wannaree Mahawong, MD 662-419-7000 ext 8033 pooh_pu@hotmail.com

Sponsors and Collaborators

Mahidol University

Investigators

Principal Investigator:

Pinnita Prabhasawat, MD

Department of Ophthalmology, Siriraj H, Mahidol U

More Information

Responsible Party:	Department of Ophthalmology; Siriraj Hospital ( Pinnita Prabhasawat )
Study ID Numbers:	154/2551(EC1)
Study First Received:	June 24, 2008
Last Updated:	June 25, 2008
ClinicalTrials.gov Identifier:	NCT00705510
Health Authority:	Thailand: Ethical Committee

Keywords provided by Mahidol University:

Cyclosporine
Unstable tear film
Meibomain gland
Meibomian gland dysfunction

Study placed in the following topic categories:

Lacerations
Pseudoephedrine
Cyclosporine
Clotrimazole
Miconazole
Tioconazole
Tetrahydrozoline

Cyclosporins
Naphazoline
Oxymetazoline
Phenylephrine
Guaifenesin
Ephedrine
Phenylpropanolamine

Additional relevant MeSH terms:

Respiratory System Agents
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Sympathomimetics
Physiological Effects of Drugs
Enzyme Inhibitors
Cardiovascular Agents
Immunosuppressive Agents

Pharmacologic Actions
Nasal Decongestants
Autonomic Agents
Antifungal Agents
Therapeutic Uses
Vasoconstrictor Agents
Peripheral Nervous System Agents
Antirheumatic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on January 16, 2009