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NCT00704275 Clinical Trial

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

Dry Eye Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00704275
Other study ID # 391/48
Secondary ID
Status Recruiting
Phase Phase 4
First received June 20, 2008
Last updated June 23, 2008
Start date June 2007
Est. completion date October 2008

Study information
Verified date June 2008
Source Chulalongkorn University
Contact Vilavun Puangsricharern, MD
Phone 66-2256-4424
Email vilavun@hotmail.com
Is FDA regulated No
Health authority Thailand: Khon Kaen University Ethics Committee for Human Research
Study type Interventional

Clinical Trial 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.

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

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date October 2008
Est. primary completion date July 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- moderate to severe dry eye

Exclusion Criteria:

- lid anomaly, previous CsA use

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• 0.05% cyclosporin eye drop
bid dosage for 4 months

Locations
Country Name City State
Thailand OPD Chulalongkorn University Hospital Bangkok
Thailand OPD Chulalongkorn University Hospital Bangkok

Sponsors (2)
Lead Sponsor Collaborator
Chulalongkorn University Allergan

Country where clinical trial is conducted

Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary Corneal and conjunctival staining score 1 year Yes
Secondary Schirmer 1 score 1 year Yes
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