Expired Study
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Fort Worth, Texas 76134


Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: - 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 Screening Visit; - Other protocol-defined inclusion criteria may apply. Exclusion Criteria: - 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 outcome; - 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 Visit; - 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.


NCT ID:

NCT02470429


Primary Contact:

Study Director
Senior Clinical Manager, 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 19, 2017

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