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

June 23, 2008 updated by: Chulalongkorn University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10330
        • Active, not recruiting
        • OPD Chulalongkorn University Hospital
      • Bangkok, Thailand
        • Recruiting
        • OPD Chulalongkorn University Hospital
        • Contact:
          • Vilavun Puangsricharern, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • moderate to severe dry eye

Exclusion Criteria:

  • lid anomaly, previous CsA use

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
0.05% cyclosporin
Drug: 0.05% cyclosporin eye drop
bid dosage for 4 months
Active Comparator: B
Refresh
Drug: 0.05% cyclosporin eye drop
bid dosage for 4 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Corneal and conjunctival staining score
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Schirmer 1 score
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chulalongkorn University

Collaborators

Allergan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Anticipated)

July 1, 2008

Study Completion (Anticipated)

October 1, 2008

Study Registration Dates

First Submitted

June 20, 2008

First Submitted That Met QC Criteria

June 23, 2008

First Posted (Estimate)

June 24, 2008

Study Record Updates

Last Update Posted (Estimate)

June 24, 2008

Last Update Submitted That Met QC Criteria

June 23, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 391/48

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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