Evaluation of an Investigational Lubricant Eye Drop on Li... | NCT01066988

Studies
Evaluation of an Investigational Lubricant Eye Drop on Lipid Layer Thickness

NCT01066988

Sponsor

Alcon Research

Status

Completed

Last Update Posted

Nov 18, 2016Estimated

Enrollment

40Actual

Phase

Not Applicable

Conditions

Dry Eye

Interventions

ORB Ocular Emulsion
SootheXP Emollient (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

Feb 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

Jan 2010

Primary Completion Date

Feb 2010Actual

Completion Date

Not provided

First Submitted Date

Feb 9, 2010

First Submission Date that Met QC Criteria

Feb 9, 2010

First Posted Date

Feb 11, 2010Estimated

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 17, 2016

Last Update Posted Date

Nov 18, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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 purpose of this study is to evaluate the effects of an investigational lubricant eye drop on tear film lipid layer thickness 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

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Right Eye	Other	ORB Ocular Emulsion or SootheXP	Other: ORB Ocular Emulsion
Left Eye	Other	ORB Ocular Emulsion or SootheXP	Other: SootheXP Emollient (Lubricant) Eye Drops

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ORB Ocular Emulsion	Other	lubricant eye drop	Right Eye
SootheXP Emollient (Lubricant) Eye Drops

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Lipid layer thickness		Baseline through 120 minutes post instillation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients (minimum age 18) meeting specific criteria for dry eye.

Exclusion Criteria:

Use of topical ocular drops within 12 hours of the study visit; or use of topical ocular ointment within 36 hours of the study visit. In addition, cannot use any topical ocular drugs during study period.
History or evidence of ocular or systemic medical conditions and/or medications that would confound the evaluation.

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

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Alcon Call Center for Trial Locations		Fort Worth	Texas	76134	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21750611	Result	Benelli U. Systane lubricant eye drops in the management of ocular dryness. Clin Ophthalmol. 2011;5:783-90. doi: 10.2147/OPTH.S13773. Epub 2011 Jun 10.

ID	Term
D007766	Lacrimal Apparatus Diseases
D005128	Eye Diseases

ID	Term
D054327	Lubricants
D009883	Ophthalmic Solutions

ID	Term
D020313	Specialty Uses of Chemicals
D020164	Chemical Actions and Uses
D019999	Pharmaceutical Solutions
D012996	Solutions