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A Study of the Effect of Zinc-Hyaluronate on Ocular Surface Sensations in Patients With Dry Eye

Primary Purpose

Dry Eye

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Ophylosa tear supplement
Sponsored by
Semmelweis University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients who had been diagnosed as having dry eye symptoms for at least 3 months, with an OSDI score of ≥13 evaluated by the questionnaire of Ocular Surface Disease Index (OSDI)

Exclusion Criteria:

  • Subjects with ophthalmic conditions other than dry eye or systemic disease including blepharitis, meibomitis, lid abnormalities as well as contact lens wearers

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Intervention

    Arm Description

    Patients receiving zinc-hyaluronate eye drop

    Outcomes

    Primary Outcome Measures

    Change in OSDI (Ocular Surface Disease Index) score
    The change in OSDI (Ocular Surface Disease Index) score will be assessed using the specific OSDI questionnaire

    Secondary Outcome Measures

    Change in corneal sensitivity to selective stimulation
    Corneal sensitivity to selective (thermal, mechanical, chemical) stimulation will be assessed using the noncontact Belmonte gas esthesiometer. Mechanical, chemical (CO2 in air), and cold stimuli were used during three-second air pulses of adjustable flow rate, composition (CO2%) and temperature.The good reproducibility of mechanical, heat and chemical threshold measurements using noncontact esthesiometers has been previously reported in several studies.

    Full Information

    First Posted
    October 28, 2016
    Last Updated
    October 31, 2016
    Sponsor
    Semmelweis University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02951910
    Brief Title
    A Study of the Effect of Zinc-Hyaluronate on Ocular Surface Sensations in Patients With Dry Eye
    Official Title
    A Study of the Effect of Zinc-Hyaluronate on Ocular Surface Sensations in Patients With Dry Eye
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2016 (undefined)
    Primary Completion Date
    August 2016 (Actual)
    Study Completion Date
    October 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Semmelweis University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Hyaluronic acid, a natural polymer, helps to maintain ocular surface hydration and can already be found in several artificial tears recommended to alleviate symptoms of dry eye. A recent hyaluronate modification involves zinc-hyaluronate complex formation by adding zinc-chloride to an aqueous sodium-hyaluronate resulting in a very stable molecular structure, which functions as both a mechanical barrier and a biocompatible film on the ocular surface. Apart from its beneficial elastoviscous characteristics, previous results indicate that hyaluronate can also reduce the excitability of the peripheral nociceptor endings underlying pain. Although hyaluronate is widely used in artificial tears to improve tear film stability, its effect on ocular surface sensitivity was not evaluated in patients with dry eye. The aim of this study is to investigate the characteristics of ocular surface sensations and corneal sensitivity in dry eye patients before and after long-term tear supplementation with zinc-hyaluronate.

    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
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    Patients receiving zinc-hyaluronate eye drop
    Intervention Type
    Device
    Intervention Name(s)
    Ophylosa tear supplement
    Intervention Description
    Tear film dynamics is assessed by non-invasive tear film breakup time (NI-BUT) in parallel with continuous recordings of ocular sensations during forced blinking. Corneal sensitivity thresholds to selective stimulation of corneal mechanonociceptors, thermal receptors and chemical nociceptors are assessed using the Belmonte gas esthesiometer. All baseline measurements are repeated after one month of tear supplementation with zinc-hyaluronate (Ophylosa eye drop) 4x/day
    Primary Outcome Measure Information:
    Title
    Change in OSDI (Ocular Surface Disease Index) score
    Description
    The change in OSDI (Ocular Surface Disease Index) score will be assessed using the specific OSDI questionnaire
    Time Frame
    1 month
    Secondary Outcome Measure Information:
    Title
    Change in corneal sensitivity to selective stimulation
    Description
    Corneal sensitivity to selective (thermal, mechanical, chemical) stimulation will be assessed using the noncontact Belmonte gas esthesiometer. Mechanical, chemical (CO2 in air), and cold stimuli were used during three-second air pulses of adjustable flow rate, composition (CO2%) and temperature.The good reproducibility of mechanical, heat and chemical threshold measurements using noncontact esthesiometers has been previously reported in several studies.
    Time Frame
    1 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients who had been diagnosed as having dry eye symptoms for at least 3 months, with an OSDI score of ≥13 evaluated by the questionnaire of Ocular Surface Disease Index (OSDI) Exclusion Criteria: Subjects with ophthalmic conditions other than dry eye or systemic disease including blepharitis, meibomitis, lid abnormalities as well as contact lens wearers

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    28375789
    Citation
    Perenyi K, Dienes L, Kornafeld A, Kovacs B, Kiss HJ, Szepessy Z, Nagy ZZ, Barsi A, Acosta MC, Gallar J, Kovacs I. The Effect of Tear Supplementation with 0.15% Preservative-Free Zinc-Hyaluronate on Ocular Surface Sensations in Patients with Dry Eye. J Ocul Pharmacol Ther. 2017 Jul/Aug;33(6):487-492. doi: 10.1089/jop.2016.0194. Epub 2017 Apr 4.
    Results Reference
    derived

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    A Study of the Effect of Zinc-Hyaluronate on Ocular Surface Sensations in Patients With Dry Eye

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