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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

Primary Purpose

Dry Eye

Status
Unknown status
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
0.05% cyclosporin eye drop
Sponsored by
Chulalongkorn University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye focused on measuring dry eye

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • moderate to severe dry eye

Exclusion Criteria:

  • lid anomaly, previous CsA use

Sites / Locations

  • OPD Chulalongkorn University Hospital
  • OPD Chulalongkorn University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A

B

Arm Description

0.05% cyclosporin

Refresh

Outcomes

Primary Outcome Measures

Corneal and conjunctival staining score

Secondary Outcome Measures

Schirmer 1 score

Full Information

First Posted
June 20, 2008
Last Updated
June 23, 2008
Sponsor
Chulalongkorn University
Collaborators
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT00704275
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Unknown status
Study Start Date
June 2007 (undefined)
Primary Completion Date
July 2008 (Anticipated)
Study Completion Date
October 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Chulalongkorn University
Collaborators
Allergan

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: Participants are moderate to severe dry eye patients aged more than 18 years of age Oxford staining scores of more than five. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
Keywords
dry eye

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
0.05% cyclosporin
Arm Title
B
Arm Type
Active Comparator
Arm Description
Refresh
Intervention Type
Drug
Intervention Name(s)
0.05% cyclosporin eye drop
Intervention Description
bid dosage for 4 months
Primary Outcome Measure Information:
Title
Corneal and conjunctival staining score
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Schirmer 1 score
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: moderate to severe dry eye Exclusion Criteria: lid anomaly, previous CsA use
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vilavun Puangsricharern, MD
Phone
66-2256-4424
Email
vilavun@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Anyanee Charoensri, MD
Phone
66-8464-70202
Email
anyaneeam@yahoo.com
Facility Information:
Facility Name
OPD Chulalongkorn University Hospital
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Individual Site Status
Active, not recruiting
Facility Name
OPD Chulalongkorn University Hospital
City
Bangkok
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vilavun Puangsricharern, MD

12. IPD Sharing Statement

Learn more about this trial

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

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