Bilateral, Masked Comparison of PEG-400 Based Artificial... | NCT00622037

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

NCT00622037

Sponsor

Bp Consulting, Inc

Status

Completed

Last Update Posted

Feb 3, 2010Estimated

Enrollment

70Estimated

Phase

Phase 4

Conditions

Dry Eye

Interventions

PEG-400 based artificial tear
Systane

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2008

Primary Completion Date

May 2008Actual

Completion Date

May 2008Actual

First Submitted Date

Feb 13, 2008

First Submission Date that Met QC Criteria

Feb 21, 2008

First Posted Date

Feb 22, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 2, 2010

Last Update Posted Date

Feb 3, 2010Estimated

Description Module

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 long trial.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	PEG-400 based artificial tear	Drug: PEG-400 based artificial tear
2	Active Comparator	Systane	Drug: Systane

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PEG-400 based artificial tear	Drug	Instill one drop in the randomized eye four times daily. Can be used more frequently if needed	1

Measure	Description	Time Frame
Dry Eye Signs		4 months

Measure	Description	Time Frame
Visual Quality		4 months

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Barry Schechter, MD	Florida Microsurgical Eye Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Florida Microsurgical Eye Institute		Boynton Beach	Florida	33426	United States

Condition Browse Module

MeSH Terms

ID	Term
D015352	Dry Eye Syndromes

Ancestor Terms

ID	Term
D007766	Lacrimal Apparatus Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided