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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:
ClinicalTrials.gov Identifier:
NCT00622037
First Posted: February 22, 2008
Last Update Posted: February 3, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bp Consulting, Inc
  Purpose
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.

Condition Intervention Phase
Dry Eye Drug: PEG-400 based artificial tear Drug: Systane Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Bp Consulting, Inc:

Primary Outcome Measures:
  • Dry Eye Signs [ Time Frame: 4 months ]

Secondary Outcome Measures:
  • Visual Quality [ Time Frame: 4 months ]

Estimated Enrollment: 70
Study Start Date: February 2008
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
PEG-400 based artificial tear
Drug: PEG-400 based artificial tear
Instill one drop in the randomized eye four times daily. Can be used more frequently if needed
Active Comparator: 2
Systane
Drug: Systane
Instill one drop in the randomized eye four times daily. Can be used more frequently if needed

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00622037


Locations
United States, Florida
Florida Microsurgical Eye Institute
Boynton Beach, Florida, United States, 33426
Sponsors and Collaborators
Bp Consulting, Inc
Investigators
Principal Investigator: Barry Schechter, MD Florida Microsurgical Eye Institute
  More Information

Responsible Party: Dr. Barry Schechter, Florida Microsurgical Eye Institute
ClinicalTrials.gov Identifier: NCT00622037     History of Changes
Other Study ID Numbers: 5338
First Submitted: February 13, 2008
First Posted: February 22, 2008
Last Update Posted: February 3, 2010
Last Verified: February 2010

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Lubricant Eye Drops
Ophthalmic Solutions
Pharmaceutical Solutions