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

Dry Eye Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02951910
• Other study ID #: SemmelweisU
• Status: Completed
• Phase: Phase 4
• First received: October 28, 2016
• Last updated: October 31, 2016
• Start date: July 2016
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: Semmelweis University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: Scientific and Medical Research Council Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Semmelweis University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 month	No
Secondary	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.	1 month	No