N/A
N=49
The Effect of SYSTANE® BALANCE on Tear Film Break Up Time in Dry Eye Subjects
Dry Eye
Bottom Line
View on ClinicalTrials.gov: NCT01718028 ↗Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Jan 2014
Primary outcome: Primary: Mean Change From Baseline in NITFBUT at Day 30 — 2.83; 0.66 seconds
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Propylene glycol 0.6% ocular emulsion (Other); Sodium chloride 0.9% saline solution (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in NITFBUT at Day 30 |
2.83; 0.66 | — |
| SECONDARY Mean Change From Baseline in NITFBUT at Day 14 |
1.98; 0.65 | — |
| SECONDARY Mean NITFBUT by Visit |
4.60; 4.93; 6.58; 5.57; 7.43; 5.59 | — |
| SECONDARY Percent Change From Baseline in NITFBUT by Visit |
44.99; 14.35; 65.03; 15.06 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01718028). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.