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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
  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 Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bp Consulting, Inc:

Primary Outcome Measures:
  • Dry Eye Signs [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Visual Quality [ Time Frame: 4 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr. Barry Schechter, Florida Microsurgical Eye Institute
ClinicalTrials.gov Identifier: NCT00622037     History of Changes
Other Study ID Numbers: 5338
Study First Received: February 13, 2008
Last Updated: February 2, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
 Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases

ClinicalTrials.gov processed this record on June 18, 2013