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

Phase 4

• Conditions: Dry Eye
• Interventions: Drug: 0.05% cyclosporin eye drop

• Registration Number: NCT00704275
• Lead Sponsor: Chulalongkorn University

Brief 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

Study Timeline

• Study Start: 2007-06
• Status Verified: 2008-06
• Study First Submitted: 2008-06-20
• Study First Submitted QC: 2008-06-23
• Last Update Submitted: 2008-06-23
• Study First Posted: 2008-06-24
• Last Update Posted: 2008-06-24
• Primary Completion: 2008-07
• Study Completion: 2008-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• moderate to severe dry eye

Exclusion Criteria

• lid anomaly, previous CsA use

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	0.05% cyclosporin eye drop	Refresh
A	0.05% cyclosporin eye drop	0.05% cyclosporin

Primary Outcome Measures

Name	Time	Method
Corneal and conjunctival staining score	1 year

Secondary Outcome Measures

Name	Time	Method
Schirmer 1 score	1 year

Trial Locations

Locations (1)

OPD Chulalongkorn University Hospital; 🇹🇭 Bangkok, Thailand