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

This study is currently recruiting participants.

Verified by Bp Consulting, Inc, November 2008

First Received: February 13, 2008 Last Updated: November 20, 2008 History of Changes

Sponsored by:	Bp Consulting, Inc
Information provided by:	Bp Consulting, Inc
ClinicalTrials.gov Identifier:	NCT00622037

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment

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
Estimated Study Completion Date:	May 2008
Estimated Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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
2: Active Comparator 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00622037

Contacts

Contact: Michelle Chabot

714-246-9581

michelle_bpconsulting@yahoo.com

Locations

United States, Florida
Florida Microsurgical Eye Institute	Recruiting
Boynton Beach, Florida, United States, 33426
Contact: Barry Schechter, MD 561-736-5055 BDSCH77@aol.com

Sponsors and Collaborators

Bp Consulting, Inc

Investigators

Principal Investigator:

Barry Schechter, MD

Florida Microsurgical Eye Institute

More Information

No publications provided

Responsible Party:	Florida Microsurgical Eye Institute ( Dr. Barry Schechter )
Study ID Numbers:	5338
Study First Received:	February 13, 2008
Last Updated:	November 20, 2008
ClinicalTrials.gov Identifier:	NCT00622037 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Lacerations

ClinicalTrials.gov processed this record on September 03, 2009