Clinical Evaluation Following Use of SYSTANE® ULTRA in the Management of Dry Eye

Alcon

Status

Completed

Conditions

Dry Eye Syndrome

Treatments

Drug: SYSTANE® ULTRA Lubricant Eye Drops

Study type

Interventional

Funder types

Industry

Identifiers

NCT02446015

EXC120-P001

Details and patient eligibility

About

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.

Full description

This study consists 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 will 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.

Enrollment

159 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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, for at least 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.

Exclusion criteria

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.