Safety and Effectiveness of EyePeace on Signs and Symptoms of Dry Eye Disease

November 28, 2023 updated by: He Eye Hospital
In this study, the EyePeace an eye massager will be compared with a standard-of-care warm compress treatment with evaporative dry eye disease. The objective is to asses the safety and effectiveness EyePeace eye massager is in relieving the signs and symptoms of evaporative dry eye disease.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

A prospective, contralateral-eye trial study compared the effects of Eyepeace+Heated eye mask versus Heated eye mask with dry eye patients. Following 10 min of heated eye mask on both eyes, eyelid massage therapy was applied to the right eye by device. The efficiency was evaluated at baseline (0 mins), 5 minutes (5 mins), 15 minutes (15 mins), and 30 minutes (30 mins) by having the patient perform the eyelid expression massage under the supervision of an ophthalmologist. Non-invasive breakup time (NITBUT), tear meniscus height (TMH), tear-film lipid layer (TFLL), ocular surface temperature (OST), meibomian gland quality (MGQ), meibomian gland expressibility (MGEx), best corrected visual acuity (BCVA), intraocular pressure (IOP), endothelial cell count (ECC), flat-axis keratometry value (K1), steep-axis keratometry value (K2), and central corneal thickness (CCT) were examined.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • 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 Backup

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China, 110001
        • He Eye Hospital
        • Sub-Investigator:
          • Qing Zhang, M.D.
        • Sub-Investigator:
          • Hongda Zhang, M.D.
        • Contact:
        • 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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥18 years
  • Able and willing to comply with the treatment/follow-up schedule
  • Bilateral signs and symptoms of dry eye disease or MGD

Exclusion Criteria:

  • Treat dry eye with medication or massage or fumigation within 1 month
  • The eyelids or intraocular tumor unfavorable pressure
  • Previous ocular surgery or trauma
  • Barriers to the subjects in the research of ocular surface active allergies, infection or inflammatory bowel disease
  • Intraocular pressure is less than 10 mmHg or more than 21 mmHg
  • Diabetes or other eye table, healthy body, skin diseases, or diseases of the nervous system;
  • Use any may interfere with tears within three months of systemic anti-inflammatory drugs or medicines, such as resistance to anxiety, depression and antihistamines
  • The local administration of ophthalmology recent history (in the past 30 days) including antibiotics, steroids and non-steroidal anti-inflammatory drug, or long-term use of local ophthalmic drug
  • Researchers determine patients not suitable for this study

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EyePeace+Heated eye mask group
Participants will received the HEM therapy for 10 minutes according to the manufacturer's instructions. This was followed immediately by 10 gentle squeezes of the eyelid massage device on one eye
Device: EyePeace
EyePeace a commercially available for enhancing meibum expression. The flexible, handheld device is made of silicone and provides regulated vertical pressure on closed eyelids (https://www.eyepeace.de). EyePeace will be used to assess its usefulness in improving evaporative dry eye signs and symptoms.
Other Names:
  • Eye massager
Device: Heated Eye Mask
Heated Eye Mask will be used once a day to assess its usefulness in improving evaporative dry eye signs and symptoms.
Other Names:
  • HEM
Active Comparator: Heated Eye Mask group
Participants in Heated Eye Mask group will use heated eye mask once.
Device: Heated Eye Mask
Heated Eye Mask will be used once a day to assess its usefulness in improving evaporative dry eye signs and symptoms.
Other Names:
  • HEM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Non-invasive tear break-up time
Time Frame: Baseline, 5 min, 15 min, 30 min

Changes in non-invasive initial tear film breaking time will be assessed using the Keratograph 5M (Oculus, Germany) topographer.

Three sequentially readings will be captured, and the median value will be included in the final analysis. The median value will be recorded.
Baseline, 5 min, 15 min, 30 min
Tear Film Lipid Layer
Time Frame: Baseline, 30 min
Tear Film Lipid Layer interferometry will be assessed using DR-1 (Kowa, Nagoya, Japan).
Baseline, 30 min
Expressibility of meibum grade
Time Frame: Baseline, 5 min, 15 min, 30 min

Meibum expressibility will be assessed under a slit-lamp:

Eight meibomian glands in the middle part will be evaluated on a scale of 0 to 3 (0 denoted that all glands expressible; 1 denoted that 3 to 4 glands expressible; 2 denoted those 1 to 2 glands expressible; and 3 denoted that no glands were expressible). The overall score was computed using the mean scores of these eight glands.
Baseline, 5 min, 15 min, 30 min
Quality of meibum grade
Time Frame: Baseline, 5 min, 15 min, 30 min

Meibum quality will be assessed under a slit-lamp:

Five meibomian gland in the middle parts of the eyelid will be assessed using a scale of 0 to 3 for each gland (0 represented clear meibum; 1 represented cloudy meibum; 2 represented cloudy and granular meibum; and 3 represented thick, toothpaste like consistency meibum).
Baseline, 5 min, 15 min, 30 min

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Conjunctival hyperemia (RS score)
Time Frame: Baseline, 5 min, 15 min, 30 min
Conjunctival hyperemia (RS score) will be assessed by keratograph image (Oculus, Germany) of 1156*873 pixels, redness score (RS) (accurate to 0.1 U) was displayed on the computer screen that ranged from 0.0 to 4.0.
Baseline, 5 min, 15 min, 30 min
Conjunctivocorneal epithelial staining grade
Time Frame: Baseline, 30 min

Conjunctivocorneal epithelial staining will be assessed under a slit-lamp:

Conjunctivocorneal epithelial staining will be assess corneal and conjunctival epithelium damage. Double vital staining approach with two microliters of a preservative-free solution containing 1% lissamine green and 1% sodium fluorescein will be instilled in the conjunctival sac.

The eye will be sectioned into three equal pieces (temporal conjunctiva, cornea, and nasal conjunctiva). Each region receives a maximum staining score of three points and a minimum of zero points. The combined scores from all three parts were then recorded on a scale ranging from 0 (normal) to 9 (severe).
Baseline, 30 min

Collaborators and Investigators

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

Sponsor

He Eye Hospital

Investigators

  • Study Chair: Emmanuel Eric Pazo, He Eye Hospital, Shenyang, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

December 3, 2023

Primary Completion (Estimated)

February 1, 2024

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

February 6, 2023

First Submitted That Met QC Criteria

November 28, 2023

First Posted (Estimated)

December 6, 2023

Study Record Updates

Last Update Posted (Estimated)

December 6, 2023

Last Update Submitted That Met QC Criteria

November 28, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DEDEP2023

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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