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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

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:


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:

  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

  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