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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified June 2008 by Chulalongkorn University.
Recruitment status was: Recruiting

Sponsor:

ClinicalTrials.gov Identifier:

NCT00704275

First Posted: June 24, 2008

Last Update Posted: June 24, 2008

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborator:

Allergan

Information provided by:

Chulalongkorn University

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 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

Drug Information available for: Cyclosporine

U.S. FDA Resources

Further study details as provided by Chulalongkorn University:

Primary Outcome Measures:

Corneal and conjunctival staining score [ Time Frame: 1 year ]

Secondary Outcome Measures:

Schirmer 1 score [ Time Frame: 1 year ]


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

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

moderate to severe dry eye

Exclusion Criteria:

lid anomaly, previous CsA use

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:	Vilavun Puangsricharern/Ass. Prof in Ophthalmology, Department of Ophthalmology, Faculty of Medicine, Chulalongkorn University
ClinicalTrials.gov Identifier:	NCT00704275 History of Changes
Other Study ID Numbers:	391/48
First Submitted:	June 20, 2008
First Posted:	June 24, 2008
Last Update Posted:	June 24, 2008
Last Verified:	June 2008

Keywords provided by Chulalongkorn University:


dry eye

Additional relevant MeSH terms:


Keratoconjunctivitis Sicca Dry Eye Syndromes Keratoconjunctivitis Conjunctivitis Conjunctival Diseases Eye Diseases Keratitis Corneal Diseases Lacrimal Apparatus Diseases Cyclosporins Cyclosporine	Anti-Inflammatory Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antifungal Agents Anti-Infective Agents Dermatologic Agents Antirheumatic Agents Calcineurin Inhibitors

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