Back to resultsSoothe Versus Refresh
Primary Purpose
Dry Eye Syndromes
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Soothe
Refresh Tears
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye Syndromes
Eligibility Criteria
Inclusion Criteria: adults with a diagnosis of dry eyes Schirmer's with anesthesia grade between 1-7 mm inclusive after five (5) minutes in at least one eye a corneal staining grade of greater than or equal to 2 (scale 0-4) in the same qualifying eye as the Schirmer's test Exclusion Criteria: contact lens use during the active treatment periods of the trial history of Sjogren's Syndrome temporary punctal occlusion that is still effective the current or anticipated use during the study of punctual plugs current treatment with Restasis
Sites / Locations
- Coastal Research Associates, LLC
- Michigan Cornea Associates
- Mount Sinai School of Medicine
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00284999
First Posted
January 31, 2006
Last Updated
August 21, 2006
Sponsor
Pharmaceutical Research Network
1. Study Identification
Unique Protocol Identification Number
NCT00284999
Brief Title
Soothe Versus Refresh
Study Type
Interventional
2. Study Status
Record Verification Date
August 2006
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Pharmaceutical Research Network
4. Oversight
5. Study Description
Brief Summary
To determine the ocular efficacy and safety of Soothe and Refresh Tears.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
33 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Soothe
Intervention Type
Drug
Intervention Name(s)
Refresh Tears
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adults with a diagnosis of dry eyes
Schirmer's with anesthesia grade between 1-7 mm inclusive after five (5) minutes in at least one eye
a corneal staining grade of greater than or equal to 2 (scale 0-4) in the same qualifying eye as the Schirmer's test
Exclusion Criteria:
contact lens use during the active treatment periods of the trial
history of Sjogren's Syndrome
temporary punctal occlusion that is still effective
the current or anticipated use during the study of punctual plugs
current treatment with Restasis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William C. Stewart, MD
Organizational Affiliation
Pharmaceutical Research Network, LLC
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Penny Asbell, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christopher Chow, MD
Organizational Affiliation
Michigan Cornea Associates
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Douglas G. Day, MD
Organizational Affiliation
Coastal Research Associates, LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Coastal Research Associates, LLC
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30339
Country
United States
Facility Name
Michigan Cornea Associates
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48034
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029-6574
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Soothe Versus Refresh
We'll reach out to this number within 24 hrs