Back to resultsBilateral, Masked Comparison of PEG-400 Based Artificial Tear and Systane for the Treatment of Dry Eye Signs, Symptoms and Visual Quality
Primary Purpose
Dry Eye
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
PEG-400 based artificial tear
Systane
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye
Eligibility Criteria
Inclusion Criteria:
- Patient reported dry eye symptoms (episodic, annoying, activity limiting), SES OD.
- Physician assessment of mild-moderate dry eye
- Patient willing to instill drops QID and complete entire length of protocol.
- TBUT < 10 seconds
- BCVA of 20/30 or better
Exclusion Criteria:
- Current topical cyclosporine use (Restasis)
- Current Systane use
- Refractive surgery within the last 6 months
- Oral or topical corticosteroid use
- Severe dry eye patients by physician assessment
- current active Blepharitis
- Oral Doxycyclines use
- Oral Antihistamine use
Sites / Locations
- Florida Microsurgical Eye Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
PEG-400 based artificial tear
Systane
Outcomes
Primary Outcome Measures
Dry Eye Signs
Secondary Outcome Measures
Visual Quality
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00622037
Brief Title
Bilateral, Masked Comparison of PEG-400 Based Artificial Tear and Systane for the Treatment of Dry Eye Signs, Symptoms and Visual Quality
Study Type
Interventional
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bp Consulting, Inc
4. Oversight
5. Study Description
Brief Summary
To evaluate and compare the effects of PEG-400 based artificial tear and Systane tears in mild-moderate dry eye patients. TBUT, Visual impact and subjective evaluations will be assessed in this month long trial.
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 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
PEG-400 based artificial tear
Arm Title
2
Arm Type
Active Comparator
Arm Description
Systane
Intervention Type
Drug
Intervention Name(s)
PEG-400 based artificial tear
Intervention Description
Instill one drop in the randomized eye four times daily. Can be used more frequently if needed
Intervention Type
Drug
Intervention Name(s)
Systane
Intervention Description
Instill one drop in the randomized eye four times daily. Can be used more frequently if needed
Primary Outcome Measure Information:
Title
Dry Eye Signs
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Visual Quality
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patient reported dry eye symptoms (episodic, annoying, activity limiting), SES OD.
Physician assessment of mild-moderate dry eye
Patient willing to instill drops QID and complete entire length of protocol.
TBUT < 10 seconds
BCVA of 20/30 or better
Exclusion Criteria:
Current topical cyclosporine use (Restasis)
Current Systane use
Refractive surgery within the last 6 months
Oral or topical corticosteroid use
Severe dry eye patients by physician assessment
current active Blepharitis
Oral Doxycyclines use
Oral Antihistamine use
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barry Schechter, MD
Organizational Affiliation
Florida Microsurgical Eye Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Florida Microsurgical Eye Institute
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33426
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Bilateral, Masked Comparison of PEG-400 Based Artificial Tear and Systane for the Treatment of Dry Eye Signs, Symptoms and Visual Quality
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