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Fort Worth, Texas 76134


Purpose:

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.


Study summary:

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.


Criteria:

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, 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. 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.


NCT ID:

NCT02446015


Primary Contact:

Study Director
Sr. Clinical Manager, Ophtha - GCRA
Alcon Research


Backup Contact:

N/A


Location Contact:

Fort Worth, Texas 76134
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 24, 2017

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