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
  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:


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
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 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:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Conjunctival Diseases
Conjunctivitis
Corneal Diseases
Eye Diseases
Keratitis
Keratoconjunctivitis
Lacrimal Apparatus Diseases
Ophthalmic Solutions
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014