- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00704275
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
June 23, 2008 updated by: Chulalongkorn University
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.
Study Overview
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
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Vilavun Puangsricharern, MD
- Phone Number: 66-2256-4424
- Email: vilavun@hotmail.com
Study Contact Backup
- Name: Anyanee Charoensri, MD
- Phone Number: 66-8464-70202
- Email: anyaneeam@yahoo.com
Study Locations
-
-
-
Bangkok, Thailand, 10330
- Active, not recruiting
- OPD Chulalongkorn University Hospital
-
Bangkok, Thailand
- Recruiting
- OPD Chulalongkorn University Hospital
-
Contact:
- Vilavun Puangsricharern, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- moderate to severe dry eye
Exclusion Criteria:
- lid anomaly, previous CsA use
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A
0.05% cyclosporin
|
bid dosage for 4 months
|
Active Comparator: B
Refresh
|
bid dosage for 4 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Corneal and conjunctival staining score
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Schirmer 1 score
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2007
Primary Completion (Anticipated)
July 1, 2008
Study Completion (Anticipated)
October 1, 2008
Study Registration Dates
First Submitted
June 20, 2008
First Submitted That Met QC Criteria
June 23, 2008
First Posted (Estimate)
June 24, 2008
Study Record Updates
Last Update Posted (Estimate)
June 24, 2008
Last Update Submitted That Met QC Criteria
June 23, 2008
Last Verified
June 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Eye Diseases
- Lacrimal Apparatus Diseases
- Keratoconjunctivitis
- Conjunctivitis
- Conjunctival Diseases
- Keratitis
- Corneal Diseases
- Dry Eye Syndromes
- Keratoconjunctivitis Sicca
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antirheumatic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Dermatologic Agents
- Antifungal Agents
- Pharmaceutical Solutions
- Calcineurin Inhibitors
- Ophthalmic Solutions
- Cyclosporine
- Cyclosporins
Other Study ID Numbers
- 391/48
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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