Clinical trial NCT01718028: 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
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Keywords: Systane BALANCE
Dry eye
lipid deficiency
NITFBUT
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2012-10-31
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Mean Change From Baseline in NITFBUT at Day 30
timeFrame: Baseline (Day 0), Day 30
Secondary outcomes:
measure: Mean Change From Baseline in NITFBUT at Day 14
timeFrame: Baseline (Day 0), Day 14
measure: Mean NITFBUT by Visit
timeFrame: Baseline (Day 0), Day 14, Day 30
measure: Percent Change From Baseline in NITFBUT by Visit
timeFrame: Baseline (Day 0), Day 14, Day 30
Other outcomes:
Locations:
city: Martinez
country: Argentina
facility: Consultório Oftalmológico
state: Buenos Aires
Study officials:
References: