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

October 29, 2012
November 15, 2013
September 2012
October 2012   (final data collection date for primary outcome measure)
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.
Mean Change from Baseline in Non-Invasive Tear Film Break Up Time (NITFBUT) at 30 Days [ Time Frame: Baseline (Day 0), Day 30 ] [ Designated as safety issue: No ]
The subject will be instructed to blink naturally. After 10 seconds, the subject will stare straight ahead without blinking until told otherwise. The precorneal tear film will be viewed noninvasively using a Tearscope device, and the investigator will time the occurrence of the first break in the tear film, i.e., appearance of a dry area.
Complete list of historical versions of study NCT01718028 on ClinicalTrials.gov Archive Site
  • 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.
Not Provided
Not Provided
Not Provided
 
The Effect of SYSTANE® BALANCE on Tear Film Break Up Time in Dry Eye Subjects
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

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Dry Eye
  • Other: Propylene glycol 0.6% ocular emulsion
    Other Name: SYSTANE® BALANCE
  • Other: Sodium chloride 0.9% saline solution
    Other Name: LARMABAK®
  • Experimental: SYSTANE® BALANCE
    Propylene glycol 0.6% ocular emulsion, 1 drop in each eye 4 times a day for 30 days
    Intervention: Other: Propylene glycol 0.6% ocular emulsion
  • Active Comparator: LARMABAK®
    Sodium chloride 0.9% saline solution, 1 drop in each eye 4 times a day for 30 days
    Intervention: Other: Sodium chloride 0.9% saline solution
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
51
October 2012
October 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Argentina
 
NCT01718028
RDG-11-262
No
Alcon Research
Alcon Research
Not Provided
Not Provided
Alcon Research
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP