Clinical Evaluation of Systane® Gel Drops in Dry Eye Subjects

Alcon

Status

Completed

Conditions

Dry Eye

Treatments

Other: Polyethylene Glycol, 0.4%, Propylene Glycol, 0.3% eye drops

Study type

Interventional

Funder types

Industry

Identifiers

NCT02380248

EXI639-P001 (C-13-040)

Details and patient eligibility

About

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.

Enrollment

207 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.