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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Alcon Research
- Enrollment
- 51
- Locations
- 2
- Primary Endpoint
- Mean Change From Baseline in NITFBUT at Day 30
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Participation in an investigational drug or device study within 30 days of entering this study;
- •Other protocol-defined exclusion criteria may apply.
Arms & Interventions
SYSTANE® BALANCE
Propylene glycol 0.6% ocular emulsion, 1 drop in each eye 4 times a day for 30 days
Intervention: Propylene glycol 0.6% ocular emulsion (Other)
LARMABAK®
Sodium chloride 0.9% saline solution, 1 drop in each eye 4 times a day for 30 days
Intervention: Sodium chloride 0.9% saline solution (Other)
Outcomes
Primary Outcomes
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 Outcomes
- Mean Change From Baseline in NITFBUT at Day 14(Baseline (Day 0), Day 14)
- Mean NITFBUT by Visit(Baseline (Day 0), Day 14, Day 30)
- Percent Change From Baseline in NITFBUT by Visit(Baseline (Day 0), Day 14, Day 30)