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

NCT02951910 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2016-11-01

No results posted yet for this study

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.

Conditions

  • Dry Eye

Interventions

DEVICE

Ophylosa tear supplement

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

Sponsors & Collaborators

  • Semmelweis University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2016-08-31
Completion
2016-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02951910 on ClinicalTrials.gov