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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

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ClinicalTrials.gov Identifier: NCT00704275
Recruitment Status : Unknown
Verified June 2008 by Chulalongkorn University.
Recruitment status was:  Recruiting
First Posted : June 24, 2008
Last Update Posted : June 24, 2008
Sponsor:
Collaborator:
Allergan
Information provided by:
Chulalongkorn University

Brief Summary:
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 or disease Intervention/treatment Phase
Dry Eye Drug: 0.05% cyclosporin eye drop Phase 4

Detailed Description:

Inclusion criteria:

  1. Participants are moderate to severe dry eye patients aged more than 18 years of age
  2. Oxford staining scores of more than five.
  3. 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


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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
Study Start Date : June 2007
Estimated Primary Completion Date : July 2008
Estimated Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Corneal and conjunctival staining score [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Schirmer 1 score [ Time Frame: 1 year ]


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

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

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 Posted: June 24, 2008    Key Record Dates
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