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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01718028
First received: October 29, 2012
Last updated: November 15, 2013
Last verified: November 2013
  Purpose

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 Intervention
Dry Eye
Other: Propylene glycol 0.6% ocular emulsion
Other: Sodium chloride 0.9% saline solution

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean Change From Baseline in NITFBUT at Day 30 [ Time Frame: Baseline (Day 0), Day 30 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline (Day 0), Day 14 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline (Day 0), Day 14, Day 30 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline (Day 0), Day 14, Day 30 ] [ Designated as safety issue: No ]
    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.


Enrollment: 51
Study Start Date: September 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01718028

Locations
Argentina
Consultório Oftalmológico
Martinez, Buenos Aires, Argentina
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01718028     History of Changes
Other Study ID Numbers: RDG-11-262
Study First Received: October 29, 2012
Results First Received: November 15, 2013
Last Updated: November 15, 2013
Health Authority: Argentina: Human Research Bioethics Committee

Keywords provided by Alcon Research:
Systane BALANCE
Dry eye
lipid deficiency
NITFBUT

Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Conjunctival Diseases
Conjunctivitis
Corneal Diseases
Eye Diseases
Keratitis
Keratoconjunctivitis
Lacrimal Apparatus Diseases

ClinicalTrials.gov processed this record on October 23, 2014