Evaluation of the Repeated Usage of Systane Ultra Eyedrop | NCT01051804

Studies
Evaluation of the Repeated Usage of Systane Ultra Eyedrop

NCT01051804

Sponsor

Alcon Research

Status

Completed

Last Update Posted

Feb 2, 2012Estimated

Enrollment

57Actual

Phase

Phase 4

Conditions

Dry Eye

Interventions

Systane Ultra
Optive 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

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

Nov 2009

Primary Completion Date

Jul 2010Actual

Completion Date

Not provided

First Submitted Date

Jan 18, 2010

First Submission Date that Met QC Criteria

Jan 19, 2010

First Posted Date

Jan 20, 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

Jan 31, 2012

Last Update Posted Date

Feb 2, 2012Estimated

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

57Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Systane Ultra	Experimental	Systane Ultra Lubricant Eye Drops	Other: Systane Ultra
Optive	Active Comparator	Optive Lubricant Eye Drops	Other: Optive lubricant Eye Drops

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Systane Ultra	Other	Systane Ultra 1 to 2 drops per eye at least 4 times daily for 4 weeks	Systane Ultra

Measure	Description	Time Frame
Improvement in objective vision		4 weeks

Measure	Description	Time Frame
Measurement of tear film evaporation		4 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18 years or more.
Non contact lens wearer.
Symptomatology as defined below for the Ocular Surface Disease Index (OSDI) questionnaire:
- Score ≥13 for OSDI Questionnaire total score; AND
- Scores of at least 2 for 2 out of the 6 vision related questions of the OSDI questionnaire
Best visual acuity of 6/9 or better in each eye.
Willingness to adhere to the instructions set in the clinical protocol.
Signature of the subject informed consent form.

Exclusion Criteria:

Use of systemic medication which might produce dry eye side effects.
Systemic disease which might produce dry eye side effects.
Active ocular infection.
Use of ocular medication.
Significant ocular anomaly.
Previous ocular surgery
Previous use of Restasis
Any medical condition that might be prejudicial to the study.
The subject, based on their knowledge, must NOT be pregnant or lactating at the time of enrolment.
The subject, based on his/her knowledge, must NOT have an infectious disease (e.g. hepatitis, tuberculosis) or an immunosuppressive disease (e.g. Human Immunodeficiency Virus).
The subject, based on their knowledge, must NOT have diabetes.

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

ID	Term
D007766	Lacrimal Apparatus Diseases
D005128	Eye Diseases