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Evaluation of SYSTANE Ultra Lubricant Eye Drops

Primary Purpose

Dry Eye

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SYSTANE Ultra
Optive
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Documented diagnosis of dry eyes
  • Must not have worn contact lenses for 1 week preceding enrollment

Exclusion Criteria:

  • Age related

Sites / Locations

  • Contact Call Center for Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SYSTANE Ultra

OPTIVE

Arm Description

SYSTANE Ultra Lubricant Eye Drops

OPTIVE Lubricant Eye Drops

Outcomes

Primary Outcome Measures

Tear Break-up Time
Tear breakup time is the time interval between a blink and the development of a dry spot in the tear film. Less than 10 seconds is abnormal. Dry spot is visible after fluorescein staining when viewed under a slit-lamp.
Conjunctival Staining
Conjunctival staining refers to the appearance of spots on the conjunctiva when dyed with lissamine green stain during an eye examination. Lissamine green temporarily stains the surface of the conjunctiva of the eye. An eye doctor looking at the eye's surface through a slit lamp observes the spots as green spots. Conjunctival staining grading scale is a 6 point scale, with 0 equals no staining (best case) and 6 equals maximum (worst) staining.
Corneal Staining
Corneal staining refers to the appearance of corneal abrasions when dyed with fluorescein drops during an eye examination. Fluorescein temporarily stains the surface of the cornea of the eye. An eye doctor looking at the eye's surface through a slit lamp observes the abrasions as brightly-colored spots on an otherwise smooth cornea. Corneal staining grading scale is a 15 point scale, with 0 equals no staining (best case) and 15 equals maximum (worst) staining.

Secondary Outcome Measures

Full Information

First Posted
June 19, 2008
Last Updated
January 31, 2012
Sponsor
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT00702377
Brief Title
Evaluation of SYSTANE Ultra Lubricant Eye Drops
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To evaluate the safety and efficacy of two artificial tears in dry eye patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
109 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SYSTANE Ultra
Arm Type
Experimental
Arm Description
SYSTANE Ultra Lubricant Eye Drops
Arm Title
OPTIVE
Arm Type
Active Comparator
Arm Description
OPTIVE Lubricant Eye Drops
Intervention Type
Other
Intervention Name(s)
SYSTANE Ultra
Intervention Description
SYSTANE Ultra Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
Intervention Type
Other
Intervention Name(s)
Optive
Intervention Description
Optive Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
Primary Outcome Measure Information:
Title
Tear Break-up Time
Description
Tear breakup time is the time interval between a blink and the development of a dry spot in the tear film. Less than 10 seconds is abnormal. Dry spot is visible after fluorescein staining when viewed under a slit-lamp.
Time Frame
Day 0, Day 7, Day 14, Day 28, and Day 42
Title
Conjunctival Staining
Description
Conjunctival staining refers to the appearance of spots on the conjunctiva when dyed with lissamine green stain during an eye examination. Lissamine green temporarily stains the surface of the conjunctiva of the eye. An eye doctor looking at the eye's surface through a slit lamp observes the spots as green spots. Conjunctival staining grading scale is a 6 point scale, with 0 equals no staining (best case) and 6 equals maximum (worst) staining.
Time Frame
Day 0, Day 7, Day 14, Day 28, Day 42
Title
Corneal Staining
Description
Corneal staining refers to the appearance of corneal abrasions when dyed with fluorescein drops during an eye examination. Fluorescein temporarily stains the surface of the cornea of the eye. An eye doctor looking at the eye's surface through a slit lamp observes the abrasions as brightly-colored spots on an otherwise smooth cornea. Corneal staining grading scale is a 15 point scale, with 0 equals no staining (best case) and 15 equals maximum (worst) staining.
Time Frame
Day 0, Day 7, Day 14, Day 28, Day 42

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Documented diagnosis of dry eyes Must not have worn contact lenses for 1 week preceding enrollment Exclusion Criteria: Age related
Facility Information:
Facility Name
Contact Call Center for Locations
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76134
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Evaluation of SYSTANE Ultra Lubricant Eye Drops

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