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

Primary Purpose

Dry Eye Syndrome

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SYSTANE® ULTRA Lubricant 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 Syndrome

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 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Systane Ultra QID

    Systane Ultra PRN

    Arm Description

    SYSTANE® ULTRA lubricant eye drops,1 drop in each eye, 4 times per day (QID) for 28 days

    SYSTANE® ULTRA lubricant eye drops, 1 drop in each eye, as needed (PRN) for 28 days

    Outcomes

    Primary Outcome Measures

    Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 28
    The TOSS score is a cumulative cornea and conjunctival staining score. After instilling ophthalmic dye in the eye, the investigator graded three areas of the ocular surface for dryness on a scale from 0 to 5, where 0 is "Absent" and 5 is "Severe." The three scores were summed for a resultant overall 0-15 score. The change from baseline was calculated as the TOSS score at Day 28 minus the TOSS score at baseline. A more negative change value indicates greater efficacy. One eye from each subject was chosen as the study eye and only the study eye was used for eye-level efficacy analyses.

    Secondary Outcome Measures

    Change From Baseline in Impact of Dry Eye on Everyday Life Symptom-Bother (IDEEL SB) Score at Day 28
    The IDEEL SB module is a 20 question patient reported outcome questionnaire that assesses the subject's symptoms of dry eye. An overall resultant calculated score ranges from 0 to 100, with higher scores indicating greater symptom bother. One eye from each subject was chosen as the study eye and only the study eye was used for eye-level efficacy analyses.
    Change From Baseline in IDEEL Treatment Satisfaction Scores (Treatment Effectiveness and Treatment-related Inconvenience) at Day 28
    The IDEEL is 10-question patient-reported outcome questionnaire that assesses the subject's general satisfaction with treatment use (Treatment Effectiveness and Treatment Inconvenience). A resultant overall 0-100 treatment satisfaction score was calculated separately for Treatment Effectiveness and Treatment Inconvenience, with higher scores indicating greater satisfaction and less treatment-related bother. One eye from each subject was chosen as the study eye and only the study eye was used for eye-level efficacy analyses.

    Full Information

    First Posted
    May 13, 2015
    Last Updated
    May 31, 2018
    Sponsor
    Alcon Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02446015
    Brief Title
    Clinical Evaluation Following Use of SYSTANE® ULTRA in the Management of Dry Eye
    Official Title
    Clinical Evaluation Following Use of SYSTANE® ULTRA in the Management of Dry Eye
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    June 19, 2015 (Actual)
    Primary Completion Date
    June 21, 2016 (Actual)
    Study Completion Date
    June 21, 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 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.
    Detailed 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.

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Systane Ultra QID
    Arm Type
    Experimental
    Arm Description
    SYSTANE® ULTRA lubricant eye drops,1 drop in each eye, 4 times per day (QID) for 28 days
    Arm Title
    Systane Ultra PRN
    Arm Type
    Active Comparator
    Arm Description
    SYSTANE® ULTRA lubricant eye drops, 1 drop in each eye, as needed (PRN) for 28 days
    Intervention Type
    Drug
    Intervention Name(s)
    SYSTANE® ULTRA Lubricant Eye Drops
    Other Intervention Name(s)
    SYSTANE® ULTRA
    Primary Outcome Measure Information:
    Title
    Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 28
    Description
    The TOSS score is a cumulative cornea and conjunctival staining score. After instilling ophthalmic dye in the eye, the investigator graded three areas of the ocular surface for dryness on a scale from 0 to 5, where 0 is "Absent" and 5 is "Severe." The three scores were summed for a resultant overall 0-15 score. The change from baseline was calculated as the TOSS score at Day 28 minus the TOSS score at baseline. A more negative change value indicates greater efficacy. One eye from each subject was chosen as the study eye and only the study eye was used for eye-level efficacy analyses.
    Time Frame
    Baseline (Day 0), Day 28
    Secondary Outcome Measure Information:
    Title
    Change From Baseline in Impact of Dry Eye on Everyday Life Symptom-Bother (IDEEL SB) Score at Day 28
    Description
    The IDEEL SB module is a 20 question patient reported outcome questionnaire that assesses the subject's symptoms of dry eye. An overall resultant calculated score ranges from 0 to 100, with higher scores indicating greater symptom bother. One eye from each subject was chosen as the study eye and only the study eye was used for eye-level efficacy analyses.
    Time Frame
    Baseline (Day 0), Day 28
    Title
    Change From Baseline in IDEEL Treatment Satisfaction Scores (Treatment Effectiveness and Treatment-related Inconvenience) at Day 28
    Description
    The IDEEL is 10-question patient-reported outcome questionnaire that assesses the subject's general satisfaction with treatment use (Treatment Effectiveness and Treatment Inconvenience). A resultant overall 0-100 treatment satisfaction score was calculated separately for Treatment Effectiveness and Treatment Inconvenience, with higher scores indicating greater satisfaction and less treatment-related bother. One eye from each subject was chosen as the study eye and only the study eye was used for eye-level efficacy analyses.
    Time Frame
    Baseline (Day 0), Day 28

    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 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sr. Clinical Manager, GCRA
    Organizational Affiliation
    Alcon Research
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    29715369
    Citation
    Asbell P, Vingrys AJ, Tan J, Ogundele A, Downie LE, Jerkins G, Shettle L. Clinical Outcomes of Fixed Versus As-Needed Use of Artificial Tears in Dry Eye Disease: A 6-Week, Observer-Masked Phase 4 Clinical Trial. Invest Ophthalmol Vis Sci. 2018 May 1;59(6):2275-2280. doi: 10.1167/iovs.17-23733.
    Results Reference
    derived

    Learn more about this trial

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

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