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Bilateral, Masked Comparison of PEG-400 Based Artificial Tear and Systane for the Treatment of Dry Eye Signs, Symptoms and Visual Quality

This study has been completed.
Sponsor:
Information provided by:
Bp Consulting, Inc
ClinicalTrials.gov Identifier:
NCT00622037
First received: February 13, 2008
Last updated: February 2, 2010
Last verified: February 2010
History of Changes

February 13, 2008
February 2, 2010
February 2008
May 2008   (final data collection date for primary outcome measure)
Dry Eye Signs [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00622037 on ClinicalTrials.gov Archive Site
Visual Quality [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Bilateral, Masked Comparison of PEG-400 Based Artificial Tear and Systane for the Treatment of Dry Eye Signs, Symptoms and Visual Quality
Not Provided

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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Dry Eye
  • Drug: PEG-400 based artificial tear
    Instill one drop in the randomized eye four times daily. Can be used more frequently if needed
  • Drug: 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
    Intervention: Drug: PEG-400 based artificial tear
  • Active Comparator: 2
    Systane
    Intervention: Drug: Systane
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
May 2008
May 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00622037
5338
Not Provided
Dr. Barry Schechter, Florida Microsurgical Eye Institute
Bp Consulting, Inc
Not Provided
Principal Investigator: Barry Schechter, MD Florida Microsurgical Eye Institute
Bp Consulting, Inc
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP