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

NCT04679883 | Unknown Phase 2

• 1 other identifier: GLH8NDE-201
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dry Eye Syndromes

Outcome Measures

Primary Outcomes (1)

• The change of Total Corneal Staining Score (TCSS)

  To 4 weeks after baseline visit using NEI scale (total between 0 and 15 scores)

  Between 1 day before first IP administration and 4 weeks

Secondary Outcomes (8)

• The change of Total Corneal Staining Score (TCSS)

  Between 1 day before first IP administration and 2, 8, 12 weeks

• The change of Inferior Corneal Staining Score (ICSS)

  Between 1 day before first IP administration and 2, 4, 8, 12 weeks

• The change of Conjunctival Staining Score

  Between 1 day before first IP administration and 2, 4, 8, 12 weeks

• The change of Tear Film Break-up time(TFBUT)

  Between 1 day before first IP administration and 2, 4, 8, 12 weeks

• The change of Schirmer I test

  Between 1 day before first IP administration and 2, 4, 8, 12 weeks

Study Arms (3)

GLH8NDE 5% and GLH8NDE Placebo

EXPERIMENTAL

Three times each 1 drop a day, total 6 times 1 drop of GLH8NDE 5% and GLH8NDE Placebo

Drug: 5% GLH8NDE; Drug: Placebo

GLH8NDE 5%

EXPERIMENTAL

Total 6 times 1 drop of GLH8NDE 5%

Drug: 5% GLH8NDE

GLH8NDE Placebo

PLACEBO COMPARATOR

Total 6 times 1 drop of GLH8NDE Placebo

Drug: Placebo

Interventions

5% GLH8NDE DRUG

5% GLH8NDE as eye drops

GLH8NDE 5%; GLH8NDE 5% and GLH8NDE Placebo

Placebo DRUG

Placebo as eye drops

GLH8NDE 5% and GLH8NDE Placebo; GLH8NDE Placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Over six grade as fluorescein corneal staining by National Eye Institute scale
• Schirmer I test ≤ 10 mm/5 min.
• 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

You may not qualify if:

• 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.
• Eyelid disease (blepharopathy, blepharolysis, valgus, varus valgus, etc.), conjunctival relaxation, cataracts, and eye diseases requiring treatment
• Sjogren's syndrome and secondary Sjogren's syndrome (rheumatoid arthritis, systemic lupus erythematosus, etc.)
• Diabetes not controlled despite appropriate treatment (hemoglobin A1c (HbA1c)\> 9%)
• 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
• Acute active hepatitis A, active hepatitis B or C
• Subject with the following medical history (including surgical history) at screening visit
• Organ transplant or bone marrow transplant
• History of known immunodeficiency disease or human immunodeficiency virus (HIV) infection
• Ophthalmic surgery within 1 year before screening (including LASIK/LASEK surgery)
• Subject who has undergone punctal occlusion and have not passed 12 weeks from the time point below.
• After punctal cauterization using electrocautery. After inserting a permanent, semi-permanent punctal plug. If a temporary punctal plug is inserted, remove the punctal plug.
• Subject who has administered the following drugs before the clinical trial or who need to be administered during the clinical trial.

Sponsors & Collaborators

• GL Pharm Tech Corporation: lead

Study Sites (1)

Samsung Medical Center

Seoul, Gangnam-gu, 06351, South Korea

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Central Study Contacts

Jong Hyuk Jung, MS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2020
• First Posted: December 22, 2020
• Study Start: April 1, 2021
• Primary Completion: January 30, 2022
• Study Completion: April 30, 2022
• Last Updated: January 6, 2021

Record last verified: 2021-01

Locations

KR (1)