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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Chulalongkorn University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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

Conditions

• Dry Eye

Interventions

Type	Name	Description
DRUG	0.05% cyclosporin eye drop	bid dosage for 4 months

Timeline

• Start date: 2007-06-01
• Primary completion: 2008-07-01
• Completion: 2008-10-01
• First posted: 2008-06-24
• Last updated: 2008-06-24

Locations

2 sites across 1 country: Thailand