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Trial record 1 of 1 for:    NCT02470429
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Evaluation of Clinical Outcomes After the Use of SYSTANE® HYDRATION

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ClinicalTrials.gov Identifier: NCT02470429
Recruitment Status : Completed
First Posted : June 12, 2015
Results First Posted : June 16, 2017
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Tracking Information
First Submitted Date  ICMJE June 10, 2015
First Posted Date  ICMJE June 12, 2015
Results First Submitted Date  ICMJE April 4, 2017
Results First Posted Date  ICMJE June 16, 2017
Last Update Posted Date July 2, 2018
Actual Study Start Date  ICMJE July 17, 2015
Actual Primary Completion Date May 26, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 16, 2017)
Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 42 [ Time Frame: Baseline (Day 0), 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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 11, 2015)
Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 42 [ Time Frame: Day 42 ]
The TOSS score is a cumulative cornea and conjunctival staining score. After instilling ophthalmic dye in the eye, the investigator grades 3 areas of the ocular surface for dryness on a scale from 0 to 5, where 0=Absent and 5=Severe. The 3 scores are summed for a resultant overall 0-15 score.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 16, 2017)
  • Change From Baseline in IDEEL Treatment Effectiveness Score at Day 42 [ Time Frame: Baseline (Day 0), 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 [ Time Frame: Baseline (Day 0), 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 [ Time Frame: Baseline (Day 0), 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2015)
  • Change from Baseline in IDEEL Treatment Satisfaction Scores (effectiveness and inconvenience) at Day 42 [ Time Frame: Day 42 ]
    The IDEEL (Impact of dry eye on everyday life) is 10-question patient-reported outcome questionnaire that assesses the subject's general satisfaction with treatment use. A resultant overall 0-100 treatment satisfaction score is calculated, with higher scores indicating greater satisfaction and less treatment-related bother.
  • Change From Baseline in Tear Film Break-up Time (TFBUT) at Day 42 [ Time Frame: Day 42 ]
    TFBUT is defined as the time elapsed between eye opening after a blink and the appearance of the first break in the tear film, ie, dry area. A longer tear film break-up time indicates a more stable tear film and may lead to improvement in dry eye symptoms.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Clinical Outcomes After the Use of SYSTANE® HYDRATION
Official Title  ICMJE Evaluation of Clinical Outcomes Following the Use of SYSTANE® HYDRATION in Subjects With Dry Eye
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Dry Eye
Intervention  ICMJE
  • Device: SYSTANE HYDRATION lubricant eye drops
    Preserved with POLYQUAD (polidronium chloride) 0.001%
    Other Name: SYSTANE® HYDRATION
  • Device: Hyabak 0.15% eye drops
    Preservative-free
    Other Name: Hyabak 0.15%
  • Drug: 0.9% saline eye drops
    Preservative-free, one drop 4 times a day in each eye (run-in period)
Study Arms  ICMJE
  • Experimental: SYSTANE HYDRATION
    SYSTANE HYDRATION lubricant eye drops, 1 drop 4 times per day (QID) in each eye for 42 days
    Interventions:
    • Device: SYSTANE HYDRATION lubricant eye drops
    • Drug: 0.9% saline eye drops
  • Active Comparator: Hyabak 0.15%
    Hyabak 0.15% eye drops, 1 drop 4 times per day (QID) in each eye for 42 days
    Interventions:
    • Device: Hyabak 0.15% eye drops
    • Drug: 0.9% saline eye drops
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 27, 2016)
114
Original Estimated Enrollment  ICMJE
 (submitted: June 11, 2015)
100
Actual Study Completion Date  ICMJE May 26, 2016
Actual Primary Completion Date May 26, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT02470429
Other Study ID Numbers  ICMJE EXK947-P001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alcon Research
Study Sponsor  ICMJE Alcon Research
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Global Trial Leader, Global Development Operations Alcon, A Novartis Division
PRS Account Alcon Research
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP