Product Preference With Systane Compared to Artificial Te... | NCT00347984

Studies
Product Preference With Systane Compared to Artificial Tears on Frequency of Drop Use

NCT00347984

Sponsor

Alcon Research

Status

Completed

Last Update Posted

Apr 10, 2012Estimated

Enrollment

Phase

Not Applicable

Conditions

Dry Eye

Interventions

Systane Lubricant eye drops

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

Aug 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

Dec 2005

Primary Completion Date

Feb 2006Actual

Completion Date

Feb 2006Actual

First Submitted Date

Jun 30, 2006

First Submission Date that Met QC Criteria

Jul 3, 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

Apr 7, 2012

Last Update Posted Date

Apr 10, 2012Estimated

Name	Class
ORA, Inc.	INDUSTRY

Description Module

Brief Summary

The objective of this study was to evaluate the effect of Systane® compared to marketed artificial tears on the frequency of drop use.

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

Name	Type	Description	Arm Group Labels	Other Names
Systane Lubricant eye drops	Other

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Frequency of drop use and/or desire to use; Drop preference

Secondary Outcomes

Measure	Description	Time Frame
Product questionnaire; Symptoms; Corneal and conjunctival staining; Tear film break-up time (TFBUT).

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects age 18 (minimum); reported history of dry eye syndrome in both eyes; TFBUT ≤ 7 seconds in at least 1 eye at Visit 1; ≥ 1+ fluorescein staining score in any region in at least 1 eye at Visit 1; desire to use an artificial tear substitute for dry eye symptoms at least 4 times per day at Visit 1 and Visit 2.

Exclusion Criteria:

Age less than 18 years

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

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mike Christensen	Alcon Research	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Maryland		Andover	Massachusetts	01845	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