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Evaluation of Clinical Outcomes After the Use of SYSTANE® HYDRATION

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Dry Eye Device: SYSTANE HYDRATION lubricant eye drops Device: Hyabak 0.15% eye drops Drug: 0.9% saline eye drops Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of Clinical Outcomes Following the Use of SYSTANE® HYDRATION in Subjects With Dry Eye
Actual Study Start Date : July 17, 2015
Actual Primary Completion Date : May 26, 2016
Actual Study Completion Date : May 26, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Systane

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 Name: 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
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)




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02470429


Sponsors and Collaborators
Alcon Research
Investigators
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Study Director: Global Trial Leader, Global Development Operations Alcon, A Novartis Division
Additional Information:
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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT02470429    
Other Study ID Numbers: EXK947-P001
First Posted: June 12, 2015    Key Record Dates
Results First Posted: June 16, 2017
Last Update Posted: July 2, 2018
Last Verified: June 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Ophthalmic Solutions
Lubricant Eye Drops
Pharmaceutical Solutions