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Dry Eye SyndromesPhase 2NCT04679883

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

A Phase 2 study testing 5% GLH8NDE in people with Dry Eye Syndromes, run by GL Pharm Tech Corporation at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Dry Eye Syndromes
What is being tested?
5% GLH8NDE
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
99 participants
Where
1 siteSouth Korea
Study dates
1 Apr 2021to 30 Apr 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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%)
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  • 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.
  • Cyclosporine eye drops within 6 weeks before screening
  • Ophthalmic solutions or antibiotics due to blepharitis, meibomian gland disease, herpes zoster, and eye infection within 6 weeks before screening
  • Drugs that cause dry eye within 6 weeks before screening (anticholinergics, isotretinoin, etc.)
  • Oral aspirin or drugs containing aspirin within 6 weeks before screening
  • Contains corticosteroids, mast cell stabilizers, antihistamines, anti-inflammatory drugs (NSAIDs, etc.), gamma linolenic acid, or omega-3 fatty acids within 6 weeks before screening
  • Other ophthalmic solutions within 3 days before screening
  • Subject who wears contact lenses within 1 week before screening or who needs to wear them during the clinical trial
  • Subject with alcoholism or drug abuse history within 1 year before screening
  • Pregnant women, lactating women, and those who disagree with appropriate contraception during the clinical trial (visit 1 to visit 6)
  • Subject with hypersensitivity to investigator's drugs or their excipients
  • Subject who participated in other clinical trials within 4 weeks before screening and received/received investigator's drug or clinical trial medical devices
  • Subject judged by other investigators to be inappropriate to participate in this clinical trial

Trial locations and contacts

1 site in 1 country.

Jong Hyuk Jung, MS contact

82-31-739-5220 ext. 403

jhjung@glpt.co.kr

South Korea1 site

  • Samsung Medical Center

    Seoul, Gangnam-gu, 06351

    Tae-Young Chung, MD, Ph D.

    Dong Hui Lim, MD, Ph D.

Other trials in South Korea

About this study

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

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.

Being tested
5% GLH8NDE, Placebo
Medical subject headings
Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 5% GLH8NDEDrug

    5% GLH8NDE as eye drops

  • PlaceboDrug

    Placebo as eye drops

Study groups in NCT04679883
Study groupRoleWhat they receive
GLH8NDE 5% and GLH8NDE PlaceboExperimentalThree times each 1 drop a day, total 6 times 1 drop of GLH8NDE 5% and GLH8NDE Placebo
Receives: Drug: 5% GLH8NDE; Drug: Placebo
GLH8NDE 5%ExperimentalTotal 6 times 1 drop of GLH8NDE 5%
Receives: Drug: 5% GLH8NDE
GLH8NDE PlaceboPlacebo comparatorTotal 6 times 1 drop of GLH8NDE Placebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The change of Total Corneal Staining Score (TCSS)

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

    Measured: Between 1 day before first IP administration and 4 weeks

Secondary outcomes (8)

  1. The change of Total Corneal Staining Score (TCSS)

    To 2, 8, 12 weeks after baseline visit using NEI scale (total between 0 and 15 scores, higher scores mean a worse outcome)

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

  2. The change of Inferior Corneal Staining Score (ICSS)

    To 2, 4, 8, 12 weeks after baseline visit using NEI scale (total between 0 and 15 scores, higher scores mean a worse outcome)

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

  3. The change of Conjunctival Staining Score

    To 2, 4, 8, 12 weeks after baseline visit using NEI scale (total between 0 and 18 scores, higher scores mean a worse outcome)

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

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

    To 2, 4, 8, 12 weeks after baseline visit

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

  5. The change of Schirmer I test

    To 2, 4, 8, 12 weeks after baseline visit

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

  6. The change of 5-item dry questionnaire (DEQ-5)

    To 2, 4, 8, 12 weeks after baseline visit (total between 0 and 22 socres, higher scores mean a worse outcome)

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

  7. The change of Ehlers-Danlos Syndrome (EDS) by Visual Analogue Scale (VAS)

    To 2, 4, 8, 12 weeks after baseline visit (total between 0 and 100 scores, highter scores mean a worse outcome)

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

  8. The change of Ccular Discomfort Score(ODS)

    To 2, 4, 8, 12 weeks after baseline visit (total 0 and 4 scores, higher scores mean a worse outcome)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2020
  2. Study start1 Apr 2021 (estimated)
  3. Primary completion30 Jan 2022 (estimated)
  4. Study completion30 Apr 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
99 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04679883
Sponsor's protocol ID
GLH8NDE-201
Status last verified
Jan 2021
First submitted
17 Dec 2020
Last updated
6 Jan 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 5% GLH8NDE in people with Dry Eye Syndromes, run by GL Pharm Tech Corporation at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jong Hyuk Jung, MS (82-31-739-5220 ext. 403, jhjung@glpt.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The change of Total Corneal Staining Score (TCSS) (time frame: Between 1 day before first IP administration and 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04679883.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2021.

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Clinical Trial NCT04679883 | AzTrials