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

Chulalongkorn University

Status and phase: Unknown; Phase 4

Conditions: Dry Eye

Treatments: Drug: 0.05% cyclosporin eye drop

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00704275

391/48

Details and patient eligibility

About

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.

Full 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

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• moderate to severe dry eye

Exclusion criteria

• lid anomaly, previous CsA use

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

A

Experimental group

Description:

0.05% cyclosporin

Treatment:

Drug: 0.05% cyclosporin eye drop

B

Active Comparator group

Description:

Refresh

Treatment:

Drug: 0.05% cyclosporin eye drop