NCT06158997

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2023

Completed
10 months until next milestone

Study Start

First participant enrolled

December 3, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 6, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

December 6, 2023

Status Verified

November 1, 2023

Enrollment Period

2 months

First QC Date

February 6, 2023

Last Update Submit

November 28, 2023

Conditions

Evaporative Dry Eye

Keywords

Dry eyeEye massageDiquafosolEyepeace

Outcome Measures

Primary Outcomes (4)

  • Non-invasive tear break-up time

    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

    Tear Film Lipid Layer interferometry will be assessed using DR-1 (Kowa, Nagoya, Japan).

    Baseline, 30 min

  • Expressibility of meibum grade

    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

    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 Outcomes (2)

  • Conjunctival hyperemia (RS score)

    Baseline, 5 min, 15 min, 30 min

  • Conjunctivocorneal epithelial staining grade

    Baseline, 30 min

Study Arms (2)

EyePeace+Heated eye mask group

EXPERIMENTAL

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: EyePeaceDevice: Heated Eye Mask

Heated Eye Mask group

ACTIVE COMPARATOR

Participants in Heated Eye Mask group will use heated eye mask once.

Device: Heated Eye Mask

Interventions

EyePeaceDEVICE

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.

Also known as: Eye massager
EyePeace+Heated eye mask group
Heated Eye MaskDEVICE

Heated Eye Mask will be used once a day to assess its usefulness in improving evaporative dry eye signs and symptoms.

Also known as: HEM
EyePeace+Heated eye mask groupHeated Eye Mask group

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

He Eye Hospital

Shenyang, Liaoning, 110001, China

Location

Related Publications (10)

  • Ma J, Pazo EE, Zou Z, Jin F. Prevalence of symptomatic dry eye in breast cancer patients undergoing systemic adjuvant treatment: A cross-sectional study. Breast. 2020 Oct;53:164-171. doi: 10.1016/j.breast.2020.07.009. Epub 2020 Aug 5.

    PMID: 32836200BACKGROUND

  • Craig JP, Nichols KK, Akpek EK, Caffery B, Dua HS, Joo CK, Liu Z, Nelson JD, Nichols JJ, Tsubota K, Stapleton F. TFOS DEWS II Definition and Classification Report. Ocul Surf. 2017 Jul;15(3):276-283. doi: 10.1016/j.jtos.2017.05.008. Epub 2017 Jul 20.

    PMID: 28736335BACKGROUND

  • Heidari M, Noorizadeh F, Wu K, Inomata T, Mashaghi A. Dry Eye Disease: Emerging Approaches to Disease Analysis and Therapy. J Clin Med. 2019 Sep 11;8(9):1439. doi: 10.3390/jcm8091439.

    PMID: 31514344BACKGROUND

  • Wang MTM, Feng J, Wong J, Turnbull PR, Craig JP. Randomised trial of the clinical utility of an eyelid massage device for the management of meibomian gland dysfunction. Cont Lens Anterior Eye. 2019 Dec;42(6):620-624. doi: 10.1016/j.clae.2019.07.008. Epub 2019 Jul 26.

    PMID: 31358441BACKGROUND

  • Tichenor AA, Cox SM, Ziemanski JF, Ngo W, Karpecki PM, Nichols KK, Nichols JJ. Effect of the Bruder moist heat eye compress on contact lens discomfort in contact lens wearers: An open-label randomized clinical trial. Cont Lens Anterior Eye. 2019 Dec;42(6):625-632. doi: 10.1016/j.clae.2019.09.005. Epub 2019 Oct 3.

    PMID: 31587960BACKGROUND

  • Olson MC, Korb DR, Greiner JV. Increase in tear film lipid layer thickness following treatment with warm compresses in patients with meibomian gland dysfunction. Eye Contact Lens. 2003 Apr;29(2):96-9. doi: 10.1097/01.ICL.0000060998.20142.8D.

    PMID: 12695712BACKGROUND

  • Butovich IA. Lipidomics of human Meibomian gland secretions: Chemistry, biophysics, and physiological role of Meibomian lipids. Prog Lipid Res. 2011 Jul;50(3):278-301. doi: 10.1016/j.plipres.2011.03.003. Epub 2011 Mar 31.

    PMID: 21458488BACKGROUND

  • McMonnies CW. Management of chronic habits of abnormal eye rubbing. Cont Lens Anterior Eye. 2008 Apr;31(2):95-102. doi: 10.1016/j.clae.2007.07.008. Epub 2008 Mar 19.

    PMID: 18356094BACKGROUND

  • Zhang Q, Wu Y, Song Y, Qin G, Yang L, Talwar SS, Lin T, Talwar GDS, Zhang H, Xu L, Moore JE, Pazo EE, He W. Screening Evaporative Dry Eyes Severity Using an Infrared Image. J Ophthalmol. 2021 Aug 24;2021:8396503. doi: 10.1155/2021/8396503. eCollection 2021.

    PMID: 34484814BACKGROUND

  • Chen J, Yu S, Qin G, Moutari S, Moore JE, Xu L, He W, Pazo EE, He X. Immediate sequential changes in the tear film lipid layer following eyelid massage in dry eye syndrome: A comparative control study. Heliyon. 2024 Aug 20;10(17):e36590. doi: 10.1016/j.heliyon.2024.e36590. eCollection 2024 Sep 15.

    PMID: 39286233DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

  • Emmanuel Eric Pazo

    He Eye Hospital, Shenyang, China

    STUDY CHAIR

Central Study Contacts

Emmanuel Eric E Pazo, PhD

CONTACT

0086-18612782131ericpazo@outlook.com

Hongda Zhang, MD

CONTACT

0086-13840298177596949091@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Masked examiner for all clinical assessments will not involved in the data collection or group allocation procedure for this research. The investigator will not be aware of the two groups.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective, comparative pilot study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2023

First Posted

December 6, 2023

Study Start

December 3, 2023

Primary Completion

February 1, 2024

Study Completion

April 1, 2024

Last Updated

December 6, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)