AzTrials
AzTrials

Evaporative Dry EyeNCT06158997

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

A study testing EyePeace and Heated Eye Mask in people with Evaporative Dry Eye, run by He Eye Hospital at 1 site in China.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Trial 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. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Evaporative Dry Eye
What is being tested?
EyePeace and Heated Eye Mask
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
3 Dec 2023to 1 Apr 2024
Phase
Interventional
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 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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;
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Emmanuel Eric E Pazo, PhD contact

0086-18612782131

ericpazo@outlook.com

Hongda Zhang, MD contact

0086-13840298177

596949091@qq.com

China1 site

  • He Eye Hospital

    Shenyang, Liaoning, 110001

    Jun Li, M.D., Ph.D., 0086-15104083505, robin_lijun@sina.com

    Emmanuel Eric Pazo, M.D., Ph.D., 0086-18612782131, ericpazo@outlook.com

Other trials in China

About this study

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.

Read the 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.

Being tested
EyePeace, Heated Eye Mask
Keywords
Dry eye, Eye massage, Diquafosol, Eyepeace
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.

  • EyePeaceDevice

    Also called Eye massager

    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.

  • Heated Eye MaskDevice

    Also called HEM

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

Study groups in NCT06158997
Study groupRoleWhat they receive
EyePeace+Heated eye mask groupExperimentalParticipants 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
Receives: Device: EyePeace; Device: Heated Eye Mask
Heated Eye Mask groupActive comparatorParticipants in Heated Eye Mask group will use heated eye mask once.
Receives: Device: Heated Eye Mask

What is being measured

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

  1. 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.

    Measured: Baseline, 5 min, 15 min, 30 min

  2. Tear Film Lipid Layer

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

    Measured: Baseline, 30 min

  3. 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.

    Measured: Baseline, 5 min, 15 min, 30 min

  4. 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).

    Measured: Baseline, 5 min, 15 min, 30 min

Secondary outcomes (2)

  1. Conjunctival hyperemia (RS score)

    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.

    Measured: Baseline, 5 min, 15 min, 30 min

  2. Conjunctivocorneal epithelial staining grade

    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).

    Measured: Baseline, 30 min

Timeline

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

  1. First posted6 Dec 2023
  2. Study start3 Dec 2023 (estimated)
  3. Primary completion1 Feb 2024 (estimated)
  4. Study completion1 Apr 2024 (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 N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Prospective, comparative pilot study
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06158997
Sponsor's protocol ID
DEDEP2023
Status last verified
Nov 2023
First submitted
6 Feb 2023
Last updated
6 Dec 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32836200

  • 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.

    PubMed 28736335

  • 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.

    PubMed 31514344

  • 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.

    PubMed 31358441

  • 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.

    PubMed 31587960

  • 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.

    PubMed 12695712

  • 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.

    PubMed 21458488

  • 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.

    PubMed 18356094

  • 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.

    PubMed 34484814

  • 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.

    PubMed 39286233

Questions about this trial

What is this clinical trial studying?

A study testing EyePeace and Heated Eye Mask in people with Evaporative Dry Eye, run by He Eye Hospital at 1 site in China.

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 3 inclusion and 9 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 Dec 2023. 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 China. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

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 Emmanuel Eric E Pazo, PhD (0086-18612782131, ericpazo@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Non-invasive tear break-up time (time frame: Baseline, 5 min, 15 min, 30 min). The study lists 4 primary outcomes in all. 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 NCT06158997, which also lists 10 linked publications.

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 Dec 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in