Artificial Tears Study in Mild to Moderate Dry Eye Patients | NCT00607776

Studies
Artificial Tears Study in Mild to Moderate Dry Eye Patients

NCT00607776

Sponsor

Abbott Medical Optics

Status

Completed

Last Update Posted

Feb 3, 2025Actual

Enrollment

110Actual

Phase

Phase 2

Conditions

Dry Eye

Interventions

(9587X) Blink Tears, classified as an OTC Drug with the active ingredient being plyethylene glycol 400
Systane

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

Jan 2025

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

Jan 2007

Primary Completion Date

Not provided

Completion Date

Apr 2007Actual

First Submitted Date

Dec 19, 2007

First Submission Date that Met QC Criteria

Feb 5, 2008

First Posted Date

Feb 6, 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

Jan 31, 2025

Last Update Posted Date

Feb 3, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The mean change in the subjective comfort score from baseline of the test group is at least 2.0 units less than that of the control group.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

110Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Systane	Drug: Systane
2	Experimental	Blink tears	Drug: (9587X) Blink Tears, classified as an OTC Drug with the active ingredient being plyethylene glycol 400

Interventions

Name	Type	Description	Arm Group Labels	Other Names
(9587X) Blink Tears, classified as an OTC Drug with the active ingredient being plyethylene glycol 400	Drug	Drops	2

Measure	Description	Time Frame
Subjective ocular comfort		1 Month

Measure	Description	Time Frame
Vision quality		1 Month

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Mild to moderate dry eye
over 18

Exclusion Criteria:

No concurrent ocular disease or meds

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
Eric Donnenfeld, M.D.	Ophthalmic Consultants of Long Island	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015352	Dry Eye Syndromes
D014985	Xerophthalmia

Ancestor Terms

ID	Term
D007766	Lacrimal Apparatus Diseases
D005128	Eye Diseases
D003229	Conjunctival Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011092	Polyethylene Glycols

Ancestor Terms

ID	Term
D005026	Ethylene Glycols
D006018	Glycols
D000438	Alcohols
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided