The purpose of this study is to compare SYSTANE® HYDRATION to Hyabak 0.15% based on total
ocular surface staining scores (TOSS) at Day 42.
Subjects will first be dispensed preservative-free 0.9% saline eye drops (saline eye drops)
to be used during the Run-in phase between Screening Visit and Day 0 (Visit 1). Subjects who
qualify will be randomized in a 1:1 manner to receive either treatment with SYSTANE®
HYDRATION Lubricant Eye Drops or Hyabak 0.15% Eye Drops.
- Willing and able to attend all study visits;
- Use of non-BAK (Benzalkonium Chloride) artificial tears at least once a day, for at
least 3 months prior to Screening Visit;
- Diagnosis of Dry Eye (by a health care professional) for at least 3 months prior to
- Other protocol-defined inclusion criteria may apply.
- Women of childbearing potential who are pregnant or breast feeding;
- Any hypersensitivity to the use of the study product formulations or an allergy to
any ingredient(s) contained within product formulations;
- Ocular abnormalities in either eye that could adversely affect the safety or efficacy
- Active ocular infection (bacterial, viral, or fungal) or active inflammation not
associated with dry eye;
- Use of chronic systemic medications: (prescription, over the counter,
vitamins/supplements) on a stable dose for less than 30 days prior to Screening
Visit, or any anticipated change in dosing regimen during the course of the study;
- History of 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, in the opinion of the
Investigator, preclude the safe administration of test article or safe participation
in the study;
- Use of any topical ocular over-the-counter or prescribed medications in either eye
(with the exception of artificial tears/gels/ lubricants) 2 weeks prior to Screening
- Contact lens use within 2 weeks prior to Screening Visit and unwilling to avoid
contact lens use during the course of the study;
- Unwilling to avoid use of additional artificial tears (other than study medication)
throughout the study;
- Other protocol-defined exclusion criteria may apply.