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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

NCT ID: NCT00704275

Last Updated: 2008-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2008-10-31

Brief Summary

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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

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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

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Dry Eye

Keywords

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dry eye

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A

0.05% cyclosporin

Group Type EXPERIMENTAL

0.05% cyclosporin eye drop

Intervention Type DRUG

bid dosage for 4 months

B

Refresh

Group Type ACTIVE_COMPARATOR

0.05% cyclosporin eye drop

Intervention Type DRUG

bid dosage for 4 months

Interventions

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0.05% cyclosporin eye drop

bid dosage for 4 months

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* moderate to severe dry eye

Exclusion Criteria

* lid anomaly, previous CsA use
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role collaborator

Chulalongkorn University

OTHER

Sponsor Role lead

Responsible Party

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Department of Ophthalmology, Faculty of Medicine, Chulalongkorn University

Locations

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OPD Chulalongkorn University Hospital

Bangkok, , Thailand

Site Status ACTIVE_NOT_RECRUITING

OPD Chulalongkorn University Hospital

Bangkok, , Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Vilavun Puangsricharern, MD

Role: CONTACT

Phone: 66-2256-4424

Email: [email protected]

Anyanee Charoensri, MD

Role: CONTACT

Phone: 66-8464-70202

Email: [email protected]

Facility Contacts

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Vilavun Puangsricharern, MD

Role: primary

Other Identifiers

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391/48

Identifier Type: -

Identifier Source: org_study_id