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Topical Cyclosporine and Disease Progression

Primary Purpose

Disease Progression, Disease Severity, Staining

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Restasis
Endura
Sponsored by
Innovative Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Disease Progression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Mild to Moderate dry eye symptoms

Exclusion Criteria:

  • Current use of Restasis

Sites / Locations

  • Lakeside Eye Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1.

2.

Arm Description

Outcomes

Primary Outcome Measures

Disease Severity

Secondary Outcome Measures

Staining

Full Information

First Posted
December 3, 2007
Last Updated
September 23, 2008
Sponsor
Innovative Medical
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1. Study Identification

Unique Protocol Identification Number
NCT00567983
Brief Title
Topical Cyclosporine and Disease Progression
Official Title
Topical Cyclosporine and Disease Progression
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Innovative Medical

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to evaluate the effect Restasis has in regards to disease progression.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disease Progression, Disease Severity, Staining, Schirmers, OSDI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1.
Arm Type
Active Comparator
Arm Title
2.
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Restasis
Intervention Description
Restasis- (in the eye) Instill one drop twice daily Endura- (in the eye) Instill one drop twice daily
Intervention Type
Drug
Intervention Name(s)
Endura
Intervention Description
Restasis- (in the eye) Instill one drop twice daily Endura- (in the eye) Instill one drop twice daily
Primary Outcome Measure Information:
Title
Disease Severity
Time Frame
1 yr
Secondary Outcome Measure Information:
Title
Staining
Time Frame
1 yr

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Mild to Moderate dry eye symptoms Exclusion Criteria: Current use of Restasis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanjay Rao
Organizational Affiliation
Lakeside Eye Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lakeside Eye Clinic
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60641
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Topical Cyclosporine and Disease Progression

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