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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.
Information provided by:
Bp Consulting, Inc Identifier:
First received: February 13, 2008
Last updated: February 2, 2010
Last verified: February 2010
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
Drug: Systane
Instill one drop in the randomized eye four times daily. Can be used more frequently if needed


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00622037

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

Responsible Party: Dr. Barry Schechter, Florida Microsurgical Eye Institute Identifier: NCT00622037     History of Changes
Other Study ID Numbers: 5338
Study First Received: February 13, 2008
Last Updated: February 2, 2010

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Conjunctival Diseases
Eye Diseases
Corneal Diseases
Lacrimal Apparatus Diseases
Lubricant Eye Drops
Ophthalmic Solutions
Pharmaceutical Solutions processed this record on August 18, 2017