Back to resultsA Multi-Center Randomized Study to Evaluate the Efficacy and Safety of an Investigational Lubricant Eye Drop
Primary Purpose
Dry Eye
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Carboxymethylcellulose sodium and Glycerin
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye
Eligibility Criteria
Inclusion Criteria: Mild, Moderate, or Severe Dry Eye Symptoms and current eye drop use; Reduced tear stability or tear production Exclusion Criteria: NONE
Sites / Locations
Outcomes
Primary Outcome Measures
Dry Eye Symptoms
Secondary Outcome Measures
Ocular surface damage, tear stability, tear production
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00243711
Brief Title
A Multi-Center Randomized Study to Evaluate the Efficacy and Safety of an Investigational Lubricant Eye Drop
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
April 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Allergan
4. Oversight
5. Study Description
Brief Summary
The efficacy, safety and acceptability of an investigational lubricant eye drop in subjects with dry eye will be evaluated in comparison with currently-available lubricant eye drops.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
286 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Carboxymethylcellulose sodium and Glycerin
Primary Outcome Measure Information:
Title
Dry Eye Symptoms
Secondary Outcome Measure Information:
Title
Ocular surface damage, tear stability, tear production
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Mild, Moderate, or Severe Dry Eye Symptoms and current eye drop use;
Reduced tear stability or tear production
Exclusion Criteria:
NONE
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Curtis, O.D.
Organizational Affiliation
InSight Eyecare
Official's Role
Principal Investigator
Facility Information:
City
Warrensburg
State/Province
Missouri
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Multi-Center Randomized Study to Evaluate the Efficacy and Safety of an Investigational Lubricant Eye Drop
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