Study of Application of Pulse Electrical Stimulation Around Eye in Dry Eye Disease Patients Who Are Scheduled for Laser Epithelial Keratomileusis (LASEK) Surgery

November 2, 2023 updated by: Nu Eyne Co., Ltd.

Multi-center, Placebo-controlled, Randomized, Parallel Design, Superiority, Pivotal Clinical Trial to Evaluate the Efficacy and Safety of Application of Electrical Stimulation Around Eye After Laser Keratoplasty (LASEK) in Patients With Dry Eye Syndrome.

This study aims to evaluate the efficacy and safety of applying pulse Electrical Stimulation around eye after laser keratoplasty (LASEK) in patients with dry eye syndrome.

Study Overview

Status

Status

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

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.

Detailed Description

Duration of study period (per participant): Screening period (0-4weeks). Intervention period (12weeks).

Patient needs to visit site at least 8 times (Screening, baseline, 1 day, 3day, 1, 4, 8, 12weeks based on baseline). Baseline visit will be done on the day of surgery.

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 (Estimated)

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.
178

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.
  • Not Applicable

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 Contact Backup

Study Locations

  • Korea, Republic of
      • Incheon, Korea, Republic of, 21388
        • Recruiting
        • HanGil Medical Foundation
        • Contact:
          • Sang Mok Lee, Ph. D., MD
      • Seoul, Korea, Republic of, 07301
        • Recruiting
        • Kim's Eye Hospital
        • Contact:
          • Kyung min Koh, Ph. D., MD
      • Seoul, Korea, Republic of, 03181
        • Recruiting
        • Department of Ophthalmology, Kangbuk Samsung Hospital
        • Contact:
          • Chul Young Choi, Ph. D., MD
      • Seoul, Korea, Republic of, 03722
        • Recruiting
        • Department of Ophthalmology, Severance Hospital
        • Contact:
          • Tae-im KIM, Ph. D., MD
      • Seoul, Korea, Republic of, 06192
        • Recruiting
        • Nune Eye Hospital
        • Contact:
          • Kyoung Yoon Shin, Ph. D., MD
      • Seoul, Korea, Republic of, 06351
        • Recruiting
        • Department of Ophthalmology, Samsung Medical Center
        • Contact:

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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Men and women aged 19 to 60
  • Those who are scheduled to get LASEK surgery
  • Those who have had dry eye symptoms for more than 3 months.
  • According to the guidelines for diagnosing dry eye syndrome of Korean Corneal Disease Study Group, those who fall under Grade II or higher
  • Those who TBUT test results of less than 10 seconds
  • Those who OSDI score of 13 or higher
  • Those who agreed to use contraception using a medically acceptable method during the period of clinical trial among Women of child bearing potential (WOCBP).
  • A person who voluntarily agreed to participate in this clinical trial.

Exclusion Criteria:

  • A person who has applied cyclosporin for the treatment of dry eye syndrome, drugs such as lipid-containing eye drops, topical steroid eye drops, IPL, etc., and medical devices for the treatment of dry eye syndrome within one month from the screening
  • A person with an uncontrollable systemic chronic disease.
  • Those who are allergic to drugs such as Fluorescein Solution or ophthalmic anesthetics
  • In a case where there is a history of receiving ophthalmic surgery known to affect the tear layer within the last 6 months (e.g., Cataract, Punctal plug insertion, Pterygium surgery)
  • A person who has eyelid diseases or structural abnormalities
  • A person with acute eye infection or inflammation of the eyeball not related to Meibomian gland dysfunction
  • A person with abnormalities in the eyelids or eyelashes
  • A person with an eye condition or ophthalmic disease that is considered unsuitable for surgery
  • A person who takes systemic drugs (e.g., tetracycline derivatives, antihistamine, isotretinoin)
  • Pregnant or lactating women
  • Those who can't understand or read the consent form of this clinical trial (e.g., illiterate or foreigners)
  • Any other cases that PI considers hard to participate in this clinical trial (e.g., heart-related problems, seizure, epilepsy. Patients transplanted metal or electronic device in head & neck. Patient suffering from unknown pain. Patients who are warned not to use our clinical trial device or is prohibited from using it (e.g., pacemaker user).)
  • Those who wore contact lenses within 72 hours before screening or who must wear contact lenses during the clinical trial period
  • Those who have taken the relevant systemic drugs (steroids, immunosuppressants, omega-3 and anticholinergic drugs, etc.) within 30 days from the date of screening
  • Those who are judged to have problems attaching electrodes due to inflammatory reactions or other dermatological problems in the skin around the orbit where the electrodes of medical devices are attached
  • Those who participated in other clinical trial within 30 days from the screening date

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: Single

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: Experimental Group
Charge-Balanced, Symmetric Nerve Stimulation device 30 mins once a day for 4weeks(28days) and twice a week from the 5weeks to the 12 week.
Device: Charge-Balanced, Symmetric Nerve Stimulation
Charge-Balanced, Symmetric Nerve Stimulation device 30 mins once a day for 4weeks(28days) and twice a week from the 5weeks to the 12 week.
Sham Comparator: Control Group
Sham device 30 mins once a day for 4weeks(28days) and twice a week from the 5weeks to the 12 week.
Device: Sham Stimulation
Sham device 30 mins once a day for 4weeks(28days) and twice a week from the 5weeks to the 12 week.

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
Changes in Tear break-up time (T-BUT)
Time Frame: baseline, 12 weeks
Check the changes in Tear break-up time (T-BUT)
baseline, 12 weeks
Changes in Visual Analogue Scale (VAS) score
Time Frame: baseline, 1 week
Check the changes in Visual Analogue Scale (VAS) score
baseline, 1 week

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
Changes in Tear break-up time (T-BUT)
Time Frame: baseline, 1, 4, 8 weeks
Check the changes in Tear break-up time (T-BUT)
baseline, 1, 4, 8 weeks
Changes in 5-Item Dry Eye Questionnaire (DEQ-5) and Ocular Surface Disease Index (OSDI) score
Time Frame: baseline, 1, 4, 8, 12 weeks
Check the changes in 5-Item Dry Eye Questionnaire Dry Eye Questionnaire (DEQ-5) and Ocular Surface Disease (OSDI) score
baseline, 1, 4, 8, 12 weeks
Changes in Visual Analogue Scale (VAS) score
Time Frame: baseline, 3 days, 4, 8, 12 weeks
Check the changes in Visual Analogue Scale (VAS) score
baseline, 3 days, 4, 8, 12 weeks
Changes in Staining Score
Time Frame: baseline, 1, 4, 8, 12 weeks
Check the changes in Staining Score
baseline, 1, 4, 8, 12 weeks
Changes in the length of the aesthesiometer's filament in centimeters
Time Frame: baseline, 1, 4, 8, 12 weeks
Check the changes in the length of the aesthesiometer's filament in centimeters
baseline, 1, 4, 8, 12 weeks
Changes in Tear Volume
Time Frame: baseline, 1, 4, 8, 12 weeks
Check the changes in Tear Volume
baseline, 1, 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.
Nu Eyne Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dong Hui Lim, Ph. D., MD, Department of Ophthalmology, Samsung Medical Center

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 (Actual)

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.
August 31, 2023

Primary Completion (Estimated)

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.
April 30, 2024

Study Completion (Estimated)

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.
August 31, 2024

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).
November 2, 2023

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.
November 2, 2023

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.
November 7, 2023

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.
November 7, 2023

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.
November 2, 2023

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.
November 1, 2023

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.
  • NE_DED_003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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