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

January 5, 2021 updated by: GL Pharm Tech Corporation

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
99

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Korea, Republic of
    • Gangnam-gu
      • Seoul, Gangnam-gu, Korea, Republic of, 06351
        • Samsung Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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
    2. History of known immunodeficiency disease or human immunodeficiency virus (HIV) infection
    3. Ophthalmic surgery within 1 year before screening (including LASIK/LASEK surgery)
    4. 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.

    1. Cyclosporine eye drops within 6 weeks before screening
    2. Ophthalmic solutions or antibiotics due to blepharitis, meibomian gland disease, herpes zoster, and eye infection within 6 weeks before screening
    3. Drugs that cause dry eye within 6 weeks before screening (anticholinergics, isotretinoin, etc.)
    4. Oral aspirin or drugs containing aspirin within 6 weeks before screening
    5. Contains corticosteroids, mast cell stabilizers, antihistamines, anti-inflammatory drugs (NSAIDs, etc.), gamma linolenic acid, or omega-3 fatty acids within 6 weeks before screening
    6. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: GLH8NDE 5% and GLH8NDE Placebo
Three times each 1 drop a day, total 6 times 1 drop of GLH8NDE 5% and GLH8NDE Placebo
Drug: Placebo
Placebo as eye drops
Drug: 5% GLH8NDE
5% GLH8NDE as eye drops
Experimental: GLH8NDE 5%
Total 6 times 1 drop of GLH8NDE 5%
Drug: 5% GLH8NDE
5% GLH8NDE as eye drops
Placebo Comparator: GLH8NDE Placebo
Total 6 times 1 drop of GLH8NDE Placebo
Drug: Placebo
Placebo as eye drops

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The change of Total Corneal Staining Score (TCSS)
Time Frame: Between 1 day before first IP administration and 4 weeks
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The change of Total Corneal Staining Score (TCSS)
Time Frame: Between 1 day before first IP administration and 2, 8, 12 weeks
To 2, 8, 12 weeks after baseline visit using NEI scale (total between 0 and 15 scores, higher scores mean a worse outcome)
Between 1 day before first IP administration and 2, 8, 12 weeks
The change of Inferior Corneal Staining Score (ICSS)
Time Frame: Between 1 day before first IP administration and 2, 4, 8, 12 weeks
To 2, 4, 8, 12 weeks after baseline visit using NEI scale (total between 0 and 15 scores, higher scores mean a worse outcome)
Between 1 day before first IP administration and 2, 4, 8, 12 weeks
The change of Conjunctival Staining Score
Time Frame: Between 1 day before first IP administration and 2, 4, 8, 12 weeks
To 2, 4, 8, 12 weeks after baseline visit using NEI scale (total between 0 and 18 scores, higher scores mean a worse outcome)
Between 1 day before first IP administration and 2, 4, 8, 12 weeks
The change of Tear Film Break-up time(TFBUT)
Time Frame: Between 1 day before first IP administration and 2, 4, 8, 12 weeks
To 2, 4, 8, 12 weeks after baseline visit
Between 1 day before first IP administration and 2, 4, 8, 12 weeks
The change of Schirmer I test
Time Frame: Between 1 day before first IP administration and 2, 4, 8, 12 weeks
To 2, 4, 8, 12 weeks after baseline visit
Between 1 day before first IP administration and 2, 4, 8, 12 weeks
The change of 5-item dry questionnaire (DEQ-5)
Time Frame: Between 1 day before first IP administration and 2, 4, 8, 12 weeks
To 2, 4, 8, 12 weeks after baseline visit (total between 0 and 22 socres, higher scores mean a worse outcome)
Between 1 day before first IP administration and 2, 4, 8, 12 weeks
The change of Ehlers-Danlos Syndrome (EDS) by Visual Analogue Scale (VAS)
Time Frame: Between 1 day before first IP administration and 2, 4, 8, 12 weeks
To 2, 4, 8, 12 weeks after baseline visit (total between 0 and 100 scores, highter scores mean a worse outcome)
Between 1 day before first IP administration and 2, 4, 8, 12 weeks
The change of Ccular Discomfort Score(ODS)
Time Frame: Between 1 day before first IP administration and 2, 4, 8, 12 weeks
To 2, 4, 8, 12 weeks after baseline visit (total 0 and 4 scores, higher scores mean a worse outcome)
Between 1 day before first IP administration and 2, 4, 8, 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GL Pharm Tech Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 30, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 17, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 22, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 6, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GLH8NDE-201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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