The purpose of this study is to evaluate the clinical benefits of SYSTANE® ULTRA Lubricant
Eye Drops using total ocular surface staining scores in subjects with dry eye administering
it either as a scheduled regimen or as-needed after 28 days of treatment. This study will be
conducted in the US and in Australia.
This study will consist of a 14-day Run-in Phase (between the Screening Visit and
Baseline/Visit 1) and a Treatment Phase. During the Run-in Phase, subjects will discontinue
current artificial tears and be dispensed SYSTANE® ULTRA to be administered 1 drop in each
eye as needed (PRN). Subjects who meet the re-evaluation criteria after the Run-in Phase
will be randomized in a 1:2 manner to receive treatment with SYSTANE® ULTRA 4 times per day
(QID) or PRN, respectively, for 28 days.
- Willing and able to attend all study visits.
- Use of BAK-free artificial tear drops on an as needed basis, at least once a week,
within 3 months prior to Screening Visit (maximum use of 4 drops a day).
- At least one '8 hour waking period' per week during the run-in phase without using
the provided artificial tear.
- Use provided artificial tear at least once a week during run-in phase.
- Willing to take study treatment as directed for the entire study and able to complete
the study diaries as required.
- Other protocol-specified inclusion criteria may apply.
- Use of artificial tears, as specified in the protocol.
- Use of topical ocular medications, as specified in the protocol.
- Women of childbearing potential who are pregnant, breast feeding, plan to become
pregnant during the study, or not using adequate birth control methods to prevent
pregnancy throughout the study.
- Any hypersensitivity to the use of the study product formulations or an allergy to
any ingredient(s) contained within product formulations.
- Ocular abnormalities, infection, or active inflammation (not associated with dry eye)
as specified in the protocol.
- Ocular or intraocular surgery or serious ocular trauma in either eye within the past
6 months prior to Screening Visit.
- Any medical condition (systemic or ophthalmic) that may preclude the safe
administration of test article or safe participation in the study.
- Contact lens use within 2 weeks prior to Screening Visit, and unwilling to avoid
contact lens use during the course of the study.
- Other protocol-specified exclusion criteria may apply.