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CompletedNCT00622037Updated Feb 3, 2010

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

A Phase 4 interventional study of PEG-400 based artificial tear and Systane in Dry Eye, sponsored by Bp Consulting, Inc. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-02-03.

Sponsored by Bp Consulting, Inc · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 long trial.

02

Conditions studied

  • Dry Eye

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03

In context

Dry Eye Syndromes

1,325 studies on the registry are indexed under Dry Eye Syndromes; 193 are open to participants now.

This study's planned enrollment of 70 is above the median of 60 across 1,103 interventional studies indexed under Dry Eye Syndromes.

Browse Dry Eye Syndromes studies →

Lead sponsor

Bp Consulting, Inc is the lead sponsor of 11 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
70 participants (estimated)

Study arms

  • Active comparator
    1

    PEG-400 based artificial tear

    Drug: PEG-400 based artificial tear

  • Active comparator
    2

    Systane

    Drug: Systane

Interventions

06

What researchers measure

Primary outcomes

  1. Dry Eye Signs

    Time frame: 4 months

Secondary outcomes

  1. Visual Quality

    Time frame: 4 months

07

Study locations

1 site
  • Florida Microsurgical Eye Institute
    Boynton Beach, Florida 33426, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Feb 2008, a primary completion of May 2008 and a completion of May 2008. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 13, 2008
First posted
Feb 22, 2008
Start
Feb 2008
Primary completionActual
May 2008
CompletionActual
May 2008
Last update
Feb 3, 2010
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 3, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00622037
Lead sponsor
Bp Consulting, Inc
First posted
Feb 22, 2008
Start date
Feb 2008
Primary completion
May 2008
Completion
May 2008
Last update
Feb 3, 2010

Study contacts

Barry Schechter, MD
principal investigator · Florida Microsurgical Eye Institute
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2010. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Polyethylene glycol 400 · Propylene Glycol

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