Status:

COMPLETED

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

Lead Sponsor:

Bp Consulting, Inc

Conditions:

Dry Eye

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief Summary

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

February 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

May 1 2008

Estimated Enrollment :

70 Patients enrolled

Trial Details

Trial ID

NCT00622037

Start Date

February 1 2008

End Date

May 1 2008

Last Update

February 3 2010

Active Locations (1)

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Florida Microsurgical Eye Institute

Boynton Beach, Florida, United States, 33426