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Evaluation of Clinical Outcomes After the Use of SYSTANE® HYDRATION

Primary Purpose

Dry Eye

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SYSTANE HYDRATION lubricant eye drops
Hyabak 0.15% eye drops
0.9% saline eye drops
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    SYSTANE HYDRATION

    Hyabak 0.15%

    Arm Description

    SYSTANE HYDRATION lubricant eye drops, 1 drop 4 times per day (QID) in each eye for 42 days

    Hyabak 0.15% eye drops, 1 drop 4 times per day (QID) in each eye for 42 days

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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.
    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.

    Full Information

    First Posted
    June 10, 2015
    Last Updated
    May 31, 2018
    Sponsor
    Alcon Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02470429
    Brief Title
    Evaluation of Clinical Outcomes After the Use of SYSTANE® HYDRATION
    Official Title
    Evaluation of Clinical Outcomes Following the Use of SYSTANE® HYDRATION in Subjects With Dry Eye
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    July 17, 2015 (Actual)
    Primary Completion Date
    May 26, 2016 (Actual)
    Study Completion Date
    May 26, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Alcon Research

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dry Eye

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    114 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    SYSTANE HYDRATION
    Arm Type
    Experimental
    Arm Description
    SYSTANE HYDRATION lubricant eye drops, 1 drop 4 times per day (QID) in each eye for 42 days
    Arm Title
    Hyabak 0.15%
    Arm Type
    Active Comparator
    Arm Description
    Hyabak 0.15% eye drops, 1 drop 4 times per day (QID) in each eye for 42 days
    Intervention Type
    Device
    Intervention Name(s)
    SYSTANE HYDRATION lubricant eye drops
    Other Intervention Name(s)
    SYSTANE® HYDRATION
    Intervention Description
    Preserved with POLYQUAD (polidronium chloride) 0.001%
    Intervention Type
    Device
    Intervention Name(s)
    Hyabak 0.15% eye drops
    Other Intervention Name(s)
    Hyabak 0.15%
    Intervention Description
    Preservative-free
    Intervention Type
    Drug
    Intervention Name(s)
    0.9% saline eye drops
    Intervention Description
    Preservative-free, one drop 4 times a day in each eye (run-in period)
    Primary Outcome Measure Information:
    Title
    Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 42
    Description
    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.
    Time Frame
    Baseline (Day 0), Day 42
    Secondary Outcome Measure Information:
    Title
    Change From Baseline in IDEEL Treatment Effectiveness Score at Day 42
    Description
    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.
    Time Frame
    Baseline (Day 0), Day 42
    Title
    Change From Baseline in IDEEL Treatment Inconvenience Score at Day 42
    Description
    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.
    Time Frame
    Baseline (Day 0), Day 42
    Title
    Change From Baseline in Tear Film Break-up Time (TFBUT) at Day 42
    Description
    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.
    Time Frame
    Baseline (Day 0), Day 42

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Global Trial Leader, Global Development Operations
    Organizational Affiliation
    Alcon, A Novartis Division
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Evaluation of Clinical Outcomes After the Use of SYSTANE® HYDRATION

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