- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00622037
Bilateral, Masked Comparison of PEG-400 Based Artificial Tear and Systane for the Treatment of Dry Eye Signs, Symptoms and Visual Quality
February 2, 2010 updated by: Bp Consulting, Inc
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
70
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Boynton Beach, Florida, United States, 33426
- Florida Microsurgical Eye Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 2
Systane
|
Instill one drop in the randomized eye four times daily.
Can be used more frequently if needed
|
Active Comparator: 1
PEG-400 based artificial tear
|
Instill one drop in the randomized eye four times daily.
Can be used more frequently if needed
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Dry Eye Signs
Time Frame: 4 months
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Visual Quality
Time Frame: 4 months
|
4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Barry Schechter, MD, Florida Microsurgical Eye Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2008
Primary Completion (Actual)
May 1, 2008
Study Completion (Actual)
May 1, 2008
Study Registration Dates
First Submitted
February 13, 2008
First Submitted That Met QC Criteria
February 21, 2008
First Posted (Estimate)
February 22, 2008
Study Record Updates
Last Update Posted (Estimate)
February 3, 2010
Last Update Submitted That Met QC Criteria
February 2, 2010
Last Verified
February 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5338 (Other Identifier: Oregon Clinical Translational Research Institute)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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