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The Effect of SYSTANE® BALANCE on Tear Film Break Up Time in Dry Eye Subjects

Primary Purpose

Dry Eye

Status
Completed
Phase
Not Applicable
Locations
Argentina
Study Type
Interventional
Intervention
Propylene glycol 0.6% ocular emulsion
Sodium chloride 0.9% saline solution
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye focused on measuring Systane BALANCE, Dry eye, lipid deficiency, NITFBUT

Eligibility Criteria

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

Inclusion Criteria:

  • Read, sign, and date an information consent;
  • Willing and able to follow instructions and maintain the appointment schedule;
  • Best-corrected visual acuity of 0.6 logMAR or better in each eye as assessed at Visit 1;
  • Must not have used any topical ocular drops for approximately 24 hours prior to Visit 1;
  • Meet protocol-specified criteria for dry eye at Visit 1;
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • History or evidence of ocular or intraocular surgery or serious ocular trauma in either eye within the past six months;
  • Current punctal occlusion of any type (e.g., collagen plugs, silicon plugs);
  • History of intolerance or hypersensitivity to any component of the study medications;
  • 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;
  • Use of systemic medications that may contribute to dry eye unless on a stable dosing regimen for a minimum of 30 days prior to Visit 1;
  • Ocular conditions such as conjunctival infections, iritis, or any other ocular condition that may preclude the safe administration of either drop under investigation;
  • Unwilling to discontinue contact lens wear during the study period. Contact lens wear must have been discontinued at least one week prior to Visit 1.
  • Participation in an investigational drug or device study within 30 days of entering this study;
  • Other protocol-defined exclusion criteria may apply.

Sites / Locations

  • Consultório Oftalmológico

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SYSTANE® BALANCE

LARMABAK®

Arm Description

Propylene glycol 0.6% ocular emulsion, 1 drop in each eye 4 times a day for 30 days

Sodium chloride 0.9% saline solution, 1 drop in each eye 4 times a day for 30 days

Outcomes

Primary Outcome Measures

Mean Change From Baseline in NITFBUT at Day 30
NITFBUT is defined as the time elapsed between eye opening after a blink and the appearance of the first break in the tear film, ie, dry area. NITFBUT was evaluated noninvasively with a Tearscope. One eye from each participant was chosen as the study eye, and only data for the study eye contributed to the analysis. A positive change value indicates an improvement in tear film stability, which may improve dry eye symptoms in dry eye sufferers.

Secondary Outcome Measures

Mean Change From Baseline in NITFBUT at Day 14
NITFBUT is defined as the time elapsed between eye opening after a blink and the appearance of the first break in the tear film, ie, dry area. NITFBUT was evaluated noninvasively with a Tearscope. One eye from each participant was chosen as the study eye, and only data for the study eye contributed to the analysis. A positive change value indicates an improvement in tear film stability, which may improve dry eye symptoms in dry eye sufferers.
Mean NITFBUT by Visit
NITFBUT is defined as the time elapsed between eye opening after a blink and the appearance of the first break in the tear film, ie, dry area. NITFBUT was evaluated noninvasively with a Tearscope. One eye from each participant was chosen as the study eye, and only data for the study eye contributed to the analysis. A longer tear film break-up time indicates a more stable tear film, which may improve dry eye symptoms in dry eye sufferers.
Percent Change From Baseline in NITFBUT by Visit
NITFBUT is defined as the time elapsed between eye opening after a blink and the appearance of the first break in the tear film, ie, dry area. NITFBUT was evaluated noninvasively with a Tearscope. One eye from each participant was chosen as the study eye, and only data for the study eye contributed to the analysis. The percentage of participants with a lengthening in tear film break up time relative to baseline is reported. A positive value indicates an improvement in film stability, which may improve dry eye symptoms in dry eye sufferers.

Full Information

First Posted
October 29, 2012
Last Updated
November 15, 2013
Sponsor
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT01718028
Brief Title
The Effect of SYSTANE® BALANCE on Tear Film Break Up Time in Dry Eye Subjects
Official Title
The Effect of SYSTANE® BALANCE on Non-Invasive Tear Film Break Up Time (NITFBUT) in Dry Eye Subjects With Lipid Deficiency Following 30 Days of Use
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (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
The purpose of this study was to evaluate the ability of SYSTANE® BALANCE dosed 4 times a day for 30 days to increase non-invasive tear film break up time over baseline, compared to a saline control, in dry eye subjects with lipid deficiency.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
Keywords
Systane BALANCE, Dry eye, lipid deficiency, NITFBUT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SYSTANE® BALANCE
Arm Type
Experimental
Arm Description
Propylene glycol 0.6% ocular emulsion, 1 drop in each eye 4 times a day for 30 days
Arm Title
LARMABAK®
Arm Type
Active Comparator
Arm Description
Sodium chloride 0.9% saline solution, 1 drop in each eye 4 times a day for 30 days
Intervention Type
Other
Intervention Name(s)
Propylene glycol 0.6% ocular emulsion
Other Intervention Name(s)
SYSTANE® BALANCE
Intervention Type
Other
Intervention Name(s)
Sodium chloride 0.9% saline solution
Other Intervention Name(s)
LARMABAK®
Primary Outcome Measure Information:
Title
Mean Change From Baseline in NITFBUT at Day 30
Description
NITFBUT is defined as the time elapsed between eye opening after a blink and the appearance of the first break in the tear film, ie, dry area. NITFBUT was evaluated noninvasively with a Tearscope. One eye from each participant was chosen as the study eye, and only data for the study eye contributed to the analysis. A positive change value indicates an improvement in tear film stability, which may improve dry eye symptoms in dry eye sufferers.
Time Frame
Baseline (Day 0), Day 30
Secondary Outcome Measure Information:
Title
Mean Change From Baseline in NITFBUT at Day 14
Description
NITFBUT is defined as the time elapsed between eye opening after a blink and the appearance of the first break in the tear film, ie, dry area. NITFBUT was evaluated noninvasively with a Tearscope. One eye from each participant was chosen as the study eye, and only data for the study eye contributed to the analysis. A positive change value indicates an improvement in tear film stability, which may improve dry eye symptoms in dry eye sufferers.
Time Frame
Baseline (Day 0), Day 14
Title
Mean NITFBUT by Visit
Description
NITFBUT is defined as the time elapsed between eye opening after a blink and the appearance of the first break in the tear film, ie, dry area. NITFBUT was evaluated noninvasively with a Tearscope. One eye from each participant was chosen as the study eye, and only data for the study eye contributed to the analysis. A longer tear film break-up time indicates a more stable tear film, which may improve dry eye symptoms in dry eye sufferers.
Time Frame
Baseline (Day 0), Day 14, Day 30
Title
Percent Change From Baseline in NITFBUT by Visit
Description
NITFBUT is defined as the time elapsed between eye opening after a blink and the appearance of the first break in the tear film, ie, dry area. NITFBUT was evaluated noninvasively with a Tearscope. One eye from each participant was chosen as the study eye, and only data for the study eye contributed to the analysis. The percentage of participants with a lengthening in tear film break up time relative to baseline is reported. A positive value indicates an improvement in film stability, which may improve dry eye symptoms in dry eye sufferers.
Time Frame
Baseline (Day 0), Day 14, Day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Read, sign, and date an information consent; Willing and able to follow instructions and maintain the appointment schedule; Best-corrected visual acuity of 0.6 logMAR or better in each eye as assessed at Visit 1; Must not have used any topical ocular drops for approximately 24 hours prior to Visit 1; Meet protocol-specified criteria for dry eye at Visit 1; Other protocol-defined inclusion criteria may apply. Exclusion Criteria: History or evidence of ocular or intraocular surgery or serious ocular trauma in either eye within the past six months; Current punctal occlusion of any type (e.g., collagen plugs, silicon plugs); History of intolerance or hypersensitivity to any component of the study medications; 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; Use of systemic medications that may contribute to dry eye unless on a stable dosing regimen for a minimum of 30 days prior to Visit 1; Ocular conditions such as conjunctival infections, iritis, or any other ocular condition that may preclude the safe administration of either drop under investigation; Unwilling to discontinue contact lens wear during the study period. Contact lens wear must have been discontinued at least one week prior to Visit 1. Participation in an investigational drug or device study within 30 days of entering this study; Other protocol-defined exclusion criteria may apply.
Facility Information:
Facility Name
Consultório Oftalmológico
City
Martinez
State/Province
Buenos Aires
Country
Argentina

12. IPD Sharing Statement

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The Effect of SYSTANE® BALANCE on Tear Film Break Up Time in Dry Eye Subjects

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