Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01718028
Recruitment Status : Completed
First Posted : October 31, 2012
Results First Posted : January 6, 2014
Last Update Posted : January 6, 2014
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Dry Eye Other: Propylene glycol 0.6% ocular emulsion Other: Sodium chloride 0.9% saline solution Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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 Start Date : September 2012
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: SYSTANE® BALANCE
Propylene glycol 0.6% ocular emulsion, 1 drop in each eye 4 times a day for 30 days
 Other: Propylene glycol 0.6% ocular emulsion
Other Name: SYSTANE® BALANCE
Active Comparator: LARMABAK®
Sodium chloride 0.9% saline solution, 1 drop in each eye 4 times a day for 30 days
 Other: Sodium chloride 0.9% saline solution
Other Name: LARMABAK®


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Mean Change From Baseline in NITFBUT at Day 30 [ Time Frame: Baseline (Day 0), 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 :
  1. Mean Change From Baseline in NITFBUT at Day 14 [ Time Frame: Baseline (Day 0), 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.

  2. Mean NITFBUT by Visit [ Time Frame: Baseline (Day 0), Day 14, 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 longer tear film break-up time indicates a more stable tear film, which may improve dry eye symptoms in dry eye sufferers.

  3. Percent Change From Baseline in NITFBUT by Visit [ Time Frame: Baseline (Day 0), Day 14, 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. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01718028


Locations
Layout table for location information
Argentina
Consultório Oftalmológico
Martinez, Buenos Aires, Argentina
Sponsors and Collaborators
Alcon Research
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01718028    
Other Study ID Numbers: RDG-11-262
First Posted: October 31, 2012    Key Record Dates
Results First Posted: January 6, 2014
Last Update Posted: January 6, 2014
Last Verified: November 2013
Keywords provided by Alcon Research:
Systane BALANCE
Dry eye
lipid deficiency
NITFBUT
Additional relevant MeSH terms:
Layout table for MeSH terms
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
 Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases