Comparison of Efficacy, Safety and Anti-Inflammatory Effect Between Topical 0.05%Cyclosporine A Emulsion and REFRESH® in Patients With Moderate to Severe Dry Eyes - Full Text View

Sponsors and Collaborators:	Chulalongkorn University Allergan
Information provided by:	Chulalongkorn University
ClinicalTrials.gov Identifier:	NCT00704275

Purpose

To compare the efficacy, safety and tolerability of 0.05% topical cyclosporin eye drop to Refresh in moderate to severe dry eye patients. Null hypothesis is: there is no difference between these two groups.

Condition	Intervention	Phase
Dry Eye	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), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Comparison of Efficacy, Safety and Anti-Inflammatory Effect Between Topical 0.05%Cyclosporine A Emulsion and REFRESH® in Patients With Moderate to Severe Dry Eyes

Further study details as provided by Chulalongkorn University:

Primary Outcome Measures:

Corneal and conjunctival staining score [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Schirmer 1 score [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	June 2007
Estimated Study Completion Date:	October 2008
Estimated Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental 0.05% cyclosporin	Drug: 0.05% cyclosporin eye drop bid dosage for 4 months
B: Active Comparator Refresh	Drug: 0.05% cyclosporin eye drop bid dosage for 4 months

Detailed Description:

Inclusion criteria:

Participants are moderate to severe dry eye patients aged more than 18 years of age
Oxford staining scores of more than five.
OSDI scores of more than 0.1

Outcome measurements:

Main parameter is staining score (corneal + conjunctival) Other parameter is OSDI score, symptom of ocular surface discomfort score, number of daily artificial tear needed, TBUT, Schirmer I score, cytokines level & markers Safety parameters: VA, IOP, cyclosporin level

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

moderate to severe dry eye

Exclusion Criteria:

lid anomaly, previous CsA use

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00704275

Contacts

Contact: Vilavun Puangsricharern, MD	66-2256-4424	vilavun@hotmail.com
Contact: Anyanee Charoensri, MD	66-8464-70202	anyaneeam@yahoo.com

Locations

Thailand
OPD Chulalongkorn University Hospital	Active, not recruiting
Bangkok, Thailand, 10330
OPD Chulalongkorn University Hospital	Recruiting
Bangkok, Thailand
Contact: Vilavun Puangsricharern, MD

Sponsors and Collaborators

Chulalongkorn University

Allergan

More Information

Responsible Party:	Department of Ophthalmology, Faculty of Medicine, Chulalongkorn University ( Vilavun Puangsricharern/Ass. Prof in Ophthalmology )
Study ID Numbers:	391/48
Study First Received:	June 20, 2008
Last Updated:	June 23, 2008
ClinicalTrials.gov Identifier:	NCT00704275
Health Authority:	Thailand: Khon Kaen University Ethics Committee for Human Research

Keywords provided by Chulalongkorn University:

dry eye

Study placed in the following topic categories:

Cyclosporine
Clotrimazole
Miconazole

Tioconazole
Tetrahydrozoline
Cyclosporins

Additional relevant MeSH terms:

Anti-Infective Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antifungal Agents
Physiological Effects of Drugs

Enzyme Inhibitors
Antirheumatic Agents
Dermatologic Agents
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009