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OpenTrials
Completed

NCT Number: NCT00622037

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

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.

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Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Florida Microsurgical Eye Institute

Boynton Beach, Florida, 33426, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PEG-400 based artificial tear

Drug

Instill one drop in the randomized eye four times daily. Can be used more frequently if needed

Systane

Drug

Instill one drop in the randomized eye four times daily. Can be used more frequently if needed

Primary outcomes

  1. Dry Eye Signs

    Time frame: 4 months

Secondary outcomes

  1. Visual Quality

    Time frame: 4 months

Sponsors and collaborators

Lead sponsor

Bp Consulting, Inc

Network

Registry information

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Feb 22, 2008
Registry last updated
Feb 3, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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