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Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of GLH8NDE in Patients With Dry Eye Disease | Clinical Trials | Clareo Health

UNKNOWNPHASE2

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

A Phase 2 Multicenter, Randomized, Double-blinded, Placebo-controlled Trial to Evaluate the Efficacy and Safety of GLH8NDE in Patients With Dry Eye Disease

NCT04679883•GL Pharm Tech Corporation

View on ClinicalTrials.gov

Summary

This study is a randomized, double-blind, placebo-controlled phase 2 clinical trial to evaluate the efficacy and safety of GLH8NDE in patients with Dry Eye Disease.

Eligibility

Age

19 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subject who is the age of older than 19 years at the screeing visit
•Subject who has symptom at least one or more as below for six months(Irritation, foreign body sensation, burning, mucus discharge, blurring, itching, photophobia, tired or heavy feeling and pain)
•Subject with dry eye syndrome who meet all of the following criteria among the left and/or right eyes at the time of screening and baseline visit.
•1. Over six grade as fluorescein corneal staining by National Eye Institute scale
•2. Schirmer I test ≤ 10 mm/5 min.
•3. TFBUT ≤ 6 seconds
•At the screening and baseline visit, the intraocular pressure(IOP) of both eyes is more than 5 mmHg and below 22 mmHg
•At the screening and baseline visit, biocular best corrected visual acuity(BCVA) are over 0.2(=+0.7 logMAR or Snellen 20/100)
•At the baseline visit, over 80% administration compliance during run-in period as placebo in single blind
•Subject who signed and dated the informed consent form after understanding fully to hear a detailed explanation in the clinical trial

Exclusion Criteria

•Ophthalmic diseases that may confuse the interpretation of clinical trial results, such as clinically significant corneal surface disease, abnormal corneal sensitivity, and abnormal tearing
•Subject with wounds caused by refractive surgery such as LASIK surgery (However, if it does not affect the clinical trial compliance and result evaluation according to the investigator's judgment, participation is possible.)
•Subject with the following concomitant diseses at screening visit.
•1. Eyelid disease (blepharopathy, blepharolysis, valgus, varus valgus, etc.), conjunctival relaxation, cataracts, and eye diseases requiring treatment
•2. Sjogren's syndrome and secondary Sjogren's syndrome (rheumatoid arthritis, systemic lupus erythematosus, etc.)
•3. Diabetes not controlled despite appropriate treatment (hemoglobin A1c (HbA1c)\> 9%)
•4. Subject with the following systemic diseases that are not controlled High blood pressure that is not controlled despite administration of antihypertensive drugs (systolic blood pressure (SBP)/diastolic blood pressure (DBP)\>160/100 mmHg) Clinically significant cardiopulmonary disease despite appropriate treatment
•5. Acute active hepatitis A, active hepatitis B or C
•Subject with the following medical history (including surgical history) at screening visit
•1. Organ transplant or bone marrow transplant
+17 more criteria

Locations (1)

Samsung Medical Center

Seoul, Gangnam-gu, South Korea

Key Dates

Start Date

April 1, 2021

Primary Completion Date

January 30, 2022

Completion Date

April 30, 2022

Last Updated

January 6, 2021

Enrollment

ESTIMATED participants

Conditions

Dry Eye Syndromes

Interventions

5% GLH8NDE

DRUG

Placebo

DRUG

Contacts

Jong Hyuk Jung, MS

CONTACT

82-31-739-5220 jhjung@glpt.co.kr

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 6, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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