Evaluation of Extended Tear Film Break Up Time (TFBUT) Wi... | NCT01368198

Studies
Evaluation of Extended Tear Film Break Up Time (TFBUT) With an Ocular Emulsion

NCT01368198

Sponsor

Alcon Research

Status

Completed

Last Update Posted

Feb 2, 2012Estimated

Enrollment

50Actual

Phase

Not Applicable

Conditions

Dry Eye

Interventions

Systane Balance Lubricating Eye Drops
OPTIVE™

Countries

United States
United Kingdom

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 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

Mar 2011

Primary Completion Date

Jun 2011Actual

Completion Date

Jun 2011Actual

First Submitted Date

May 6, 2011

First Submission Date that Met QC Criteria

Jun 6, 2011

First Posted Date

Jun 7, 2011Estimated

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, 2012

Last Update Posted Date

Feb 2, 2012Estimated

Name	Class
Optometric Technology Group Ltd	OTHER

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

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

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ocular Emulsion	Active Comparator	An Ocular Emulsion	Other: Systane Balance Lubricating Eye Drops
OPTIVE™	Active Comparator	An OPTIVE™	Other: OPTIVE™

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Systane Balance Lubricating Eye Drops	Other	One instillation of the eye drop in each eye	Ocular Emulsion

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measurement of the tear film break-up time using DET sodium fluorescein strips.		Enrollment Test visit 1

Secondary Outcomes

Measure	Description	Time Frame
Measurement of the tear film break-up time in a non invasive manner using the Tearscope®. Measurement of the tear film break-up time in a non invasive manner using the Tearscope®.		Enrollment Test visit 2

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The subject must be 18 years of age or older;
The subject must have a best corrected visual acuity of 0.6 LogMAR (~6/24) or better in each eye
The subject must not have used any topical ocular drops for approximately 24 hours prior to the enrolment/screening visit
The subject must be classified as dry eye at enrolment/screening visit according to the following criteria:
- Subjects' self-assessment of dry eye status (answer of at least "some of the time" to the question, "How often have your eyes felt dry enough to want to use eye drops?");
- TFBUT measured with DET ≤ 5 seconds in at least one eye;
- Grade 1 for meibomian gland expression in both eyes;
- Evidence of missing meibomian glands in both eyes.

Exclusion Criteria:

History or evidence of ocular or intraocular surgery in either eye within the past six months.
History or evidence of serious ocular trauma in either eye within the past six months.
Current punctal occlusion of any type (e.g., collagen plugs, silicone plugs).
History or evidence of epithelial herpes simplex keratitis (dendritic keratitis); vaccinia; active or recent varicella viral disease of the cornea and/or conjunctiva; chronic bacterial disease of the cornea and/or conjunctiva and/or eyelids; mycobacterial infection of the eye; and/or fungal disease of the eye.
Use of any concomitant topical ocular medications during the study period.
Ocular conditions such as conjunctival infections, iritis, or any other ocular condition that may preclude the safe administration of either drop under investigation.
Participation in an investigational drug or device study within 30 days of entering this study.

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

Facility	Status	City	State	ZIP	Country	Contacts
Contact Alcon Call Center for Trial Locations		Fort Worth	Texas	76134	United States
OTG Research & Consultancy

ID	Term
D007766	Lacrimal Apparatus Diseases
D005128	Eye Diseases