Safety/Efficacy of Systane Free vs Refresh Liquigel | NCT00348517

Studies
Safety/Efficacy of Systane Free vs Refresh Liquigel

NCT00348517

Sponsor

Alcon Research

Status

Completed

Last Update Posted

Mar 5, 2012Estimated

Enrollment

100Actual

Phase

Not Applicable

Conditions

Dry Eye

Interventions

Systane Free Lubricant Eye Drops
Refresh Liquigel Lubricant Eye Drops

Countries

Not provided

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

Mar 2012

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

Jul 2006

Primary Completion Date

Nov 2006Actual

Completion Date

Nov 2006

First Submitted Date

Jun 30, 2006

First Submission Date that Met QC Criteria

Jun 30, 2006

First Posted Date

Jul 4, 2006Estimated

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

Mar 2, 2012

Last Update Posted Date

Mar 5, 2012Estimated

Description Module

Brief Summary

The objective of this study is to evaluate the safety and efficacy of Systane Free FID 105783 when compared to Refresh Liquigel Lubricant Eye Drops (Allergan) in a specified population of dry eye patients.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Systane	Experimental		Other: Systane Free Lubricant Eye Drops
Refresh	Active Comparator		Other: Refresh Liquigel Lubricant Eye Drops

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Systane Free Lubricant Eye Drops	Other	1-2 drops per eye four times per day for 42 days	Systane

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in corneal staining at Day 28 from baseline (Day 0)		Day 28

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

>/= 3 corneal staining score using NEI scoring system.
Need artificial tears at least some of the time.
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

History or evidence of ocular or intraocular surgery in either eye within the past six months.
History of intolerance or hypersensitivity to any component of the study medication.
Use of Restasis within 30 days of Visit 1.
Participation in an investigational drug or device study within 30 days of entering this study.
Other protocol-defined exclusion criteria may apply.

Accepts Healthy Volunteers

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

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