Evaluation of Clinical Outcomes After the Use of SYSTANE® HYDRATION

Evaluation of Clinical Outcomes Following the Use of SYSTANE® HYDRATION in Subjects With Dry Eye

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 Overview

• Status: Completed
• Conditions: Dry Eye
• Intervention / Treatment: Device: SYSTANE HYDRATION lubricant eye drops; Drug: 0.9% saline eye drops; Device: Hyabak 0.15% eye drops

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 114
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 products or an allergy to any ingredient(s) contained within study products;
• 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 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 study products 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 the use of additional artificial tears (other than the study products) throughout the study;
• Other protocol-defined exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SYSTANE HYDRATION; SYSTANE HYDRATION lubricant eye drops, 1 drop 4 times per day (QID) in each eye for 42 days	Device: SYSTANE HYDRATION lubricant eye drops; Preserved with POLYQUAD (polidronium chloride) 0.001%; Other Names: SYSTANE® HYDRATION; Drug: 0.9% saline eye drops; Preservative-free, one drop 4 times a day in each eye (run-in period)
Active Comparator: Hyabak 0.15%; Hyabak 0.15% eye drops, 1 drop 4 times per day (QID) in each eye for 42 days	Drug: 0.9% saline eye drops; Preservative-free, one drop 4 times a day in each eye (run-in period); Device: Hyabak 0.15% eye drops; Preservative-free; Other Names: Hyabak 0.15%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 42	The TOSS score is a cumulative cornea and conjunctival staining score. After instilling ophthalmic dye in the eye, the investigator graded 3 areas of the ocular surface for dryness on a scale from 0 to 5, where 0=Absent and 5=Severe. The 3 scores were summed for a resultant overall 0-15 score. A more negative change value indicates greater efficacy. One eye (study eye) contributed to the analysis.	Baseline (Day 0), Day 42

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in IDEEL Treatment Effectiveness Score at Day 42	The IDEEL is 10-question patient-reported outcome questionnaire that assesses the subject's general satisfaction with treatment use. A resultant overall 0-100 satisfaction score was calculated, with a higher score indicating greater satisfaction and less treatment-related bother.	Baseline (Day 0), Day 42
Change From Baseline in IDEEL Treatment Inconvenience Score at Day 42	The IDEEL is 10-question patient-reported outcome questionnaire that assesses the subject's general satisfaction with treatment use. A resultant overall 0-100 satisfaction score was calculated, with a higher score indicating greater satisfaction and less treatment-related bother.	Baseline (Day 0), Day 42
Change From Baseline in Tear Film Break-up Time (TFBUT) at Day 42	TFBUT is defined as the time elapsed from the last blink until 1 or more dry spots appeared in the precorneal tear film. A longer tear film break-up time indicates a more stable tear film and may lead to improvement in dry eye symptoms. One eye (study eye) contributed to the analysis.	Baseline (Day 0), Day 42

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Global Trial Leader, Global Development Operations, Alcon, A Novartis Division

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2015
• Primary Completion (Actual): May 26, 2016
• Study Completion (Actual): May 26, 2016

Study Registration Dates

• First Submitted: June 10, 2015
• First Submitted That Met QC Criteria: June 11, 2015
• First Posted (Estimate): June 12, 2015

Study Record Updates

• Last Update Posted (Actual): July 2, 2018
• Last Update Submitted That Met QC Criteria: May 31, 2018
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Pharmaceutical Solutions; Ophthalmic Solutions; Lubricant Eye Drops
• Other Study ID Numbers: EXK947-P001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No