Efficacy of PEG-400 and Systane Artificial Tears (Alcon)... | NCT00627302

Studies
Efficacy of PEG-400 and Systane Artificial Tears (Alcon) on Quality of Vision

NCT00627302

Sponsor

Bp Consulting, Inc

Status

Completed

Last Update Posted

Nov 24, 2008Estimated

Enrollment

40Actual

Phase

Phase 4

Conditions

Myopia

Interventions

PEG-400
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

Nov 2008

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

Nov 2008Actual

Completion Date

Nov 2008Actual

First Submitted Date

Feb 22, 2008

First Submission Date that Met QC Criteria

Feb 29, 2008

First Posted Date

Mar 3, 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

Nov 20, 2008

Last Update Posted Date

Nov 24, 2008Estimated

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

40Actual

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PEG-400	Drug	Day of Surgery: Starting 2 hours after surgery Instill one drop in randomized eye every two hours. Day 1-Week 1: Instill one drop in randomized eye four times daily

Measure	Description	Time Frame
Quality of vision		5 months

Measure	Description	Time Frame
Efficacy		5 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males or females > 21 years old
Scheduled to undergo bilateral LASIK
Likely to complete all study visits and able to provide informed consent

Exclusion Criteria:

Prior or current use of topical cyclosporine within the last 1 year
Known contraindications to any study medication or ingredients
Ocular disorders
Active ocular diseases or uncontrolled systemic disease
Active ocular allergies
Complications at the time of surgery

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 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
Eric Donnenfeld, MD	Ophthalmic Consultants of Long Island	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ophthalmic Consultants of long Island		Rockville Centre	New York	11570	United States

Condition Browse Module

MeSH Terms

ID	Term
D009216	Myopia

Ancestor Terms

ID	Term
D012030	Refractive Errors
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000595213	polyethylene glycol 400

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided