Last updated on June 2008

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


Brief description of study

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.

Detailed Study 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

Clinical Study Identifier: NCT00704275

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Vilavun Puangsricharern, MD

OPD Chulalongkorn University Hospital
Bangkok, Thailand
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