Clinical Evaluation of Systane® Gel Drops in Dry Eye Subjects

Clinical Evaluation of Systane® Gel Drops on Corneal Staining in Indian Subjects With Dry Eye

The purpose of this study is to evaluate the efficacy and safety of Systane® Gel Drops in dry eye subjects following 90 days of QID (4 times/day) dosing.

Inclusion Criteria:

• Must give informed consent, and be willing and able to attend all study visits.
• Best-corrected visual acuity (BCVA) of ≥ 55 letters in each eye as measured by ETDRS (letters read method).
• Dry eye in both eyes diagnosed by an ophthalmologist.
• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Women of childbearing potential who are pregnant, test positive on a pregnancy test, or breast-feeding.
• 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.
• Any contraindications or hypersensitivities to the study medications or their components.
• Ocular surgery (of any type, including PRK, LASIK, Epilasik, etc.) or ocular trauma requiring medical or pharmacological treatment within 1 year of Screening.
• Use of topical ocular prescription or non-prescription medications, RESTASIS or topical ocular steroids within 14 days of Screening.
• Chronic medications (over the counter, prescription, or vitamins) that have not been on a stable dose for at least 30 days prior to Screening.
• Contact lens wear within 1 week of Screening and/or unwillingness to discontinue contact lens wear for the duration of the study.
• Participation in any other clinical trial within 30 days prior to Screening.
• Other protocol-specified exclusion criteria may apply.