Trial | NCT00622037  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    70
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.
Study Started
Feb 29
2008
Primary Completion
May 31
2008
Study Completion
May 31
2008
Last Update
Feb 03
2010
Estimate

Drug PEG-400 based artificial tear

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

Drug Systane

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

1 Active Comparator

PEG-400 based artificial tear

2 Active Comparator

Systane

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
No Results Posted