NCT04104997 is a Phase 1 clinical trial of 5% GLH8NDE in Dry Eye Syndromes, sponsored by GL Pharm Tech Corporation.

Who is sponsoring NCT04104997?

NCT04104997 is sponsored by GL Pharm Tech Corporation.

What drugs are being tested in NCT04104997?

Interventions in NCT04104997: 5% GLH8NDE, Placebos.

What condition does NCT04104997 study?

NCT04104997 studies Dry Eye Syndromes.

Is NCT04104997 still recruiting?

NCT04104997 is currently completed. Last updated 19 December 2020.

Last reviewed 2020-12-19 · How we verify

NCT04104997

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of GLH8NDE After Single and Mutiple Ocular Administrations in Healthy Korean and Caucasian Volunteers

Completed Phase 1 Last updated 19 December 2020

What this trial tests

Phase 1 trial testing 5% GLH8NDE in Dry Eye Syndromes in 39 participants. Completed in 17 July 2020.

Timeline

26 September 2019

Primary endpoint
18 February 2020

17 July 2020

Quick facts

Lead sponsor	GL Pharm Tech Corporation
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	double
Primary purpose	treatment
Enrollment	39
Start date	26 September 2019
Primary completion	18 February 2020
Estimated completion	17 July 2020
Sites	1 location across South Korea

Drugs / interventions tested

5% GLH8NDE — full drug profile →
Placebos — full drug profile →

Conditions studied

Dry Eye Syndromes — all drugs for Dry Eye Syndromes →

Sponsor

GL Pharm Tech Corporation — full company profile →

Who can join

Adults 20 to 50, any sex, with Dry Eye Syndromes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is a randomized, double-blind, placebo-controlled phase 1 clinical trial to evaluate the safety, tolerability and pharmacokinetic characteristics of GLH8NDE after single and multiple ocular administrations in healthy Korean and Caucasian volunteers

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

A phase I study to evaluate the safety, tolerability, pharmacodynamic and pharmacokinetic profiles of ocular GLH8NDE in healthy male adults.
Jung J, Huh KY, Jin X, Ha A, et al · · 2022 · cited 4× · PMID 34523814 · DOI 10.1111/cts.13150

Verify or expand the search:

Other trials of 5% GLH8NDE

Trials testing the same drug.

NCT04679883 — Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of GLH8NDE in Patients With Dry Eye Disease · Phase 2 · unknown

Other recruiting trials for Dry Eye Syndromes

Currently open trials in the same condition.

NCT07412860 — Clinical Investigation Between the Topical Administration of a Tear Substitute With Ancillary Medicinal Substance and Hy · NA · recruiting
NCT06913504 — Comparison Of Blue Light Filter Feature and Blue Blocking Lenses in Digital Device Users With Dry Eye Patients · NA · active not recruiting
NCT06913465 — The Impact of Hypothyroidism on Tear Production and Dry Eye Symptoms: Implications for Optometric Care · active not recruiting
NCT06831253 — Efficacy of Platelet-Rich Plasma Injection in Dry Eye Syndrome · NA · recruiting
NCT06220474 — Therapeutic Efficacy and Safety of Non-Invasive RF Treatment in Refractory MGD · NA · recruiting

Other GL Pharm Tech Corporation trials

Trials by the same sponsor.

NCT04679883 — Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of GLH8NDE in Patients With Dry Eye Disease · Phase 2 · unknown
NCT03963362 — The Pharmacokinetics of GLA5PR Tablet According to the Renal Function · Phase 1 · unknown
NCT03927170 — Pharmacokinetic Characteristics of GLH1SM Extended Release Tablets in Healthy Volunteers(Fed) · Phase 1 · completed
NCT03851341 — Pharmacokinetic Characteristics of GLH1SM Extended Release Tablets in Healthy Volunteers · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04104997 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GL Pharm Tech Corporation
Last refreshed: 19 December 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04104997.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing