NCT05923528

Brief Summary

The lipid layer of the tear film is critical to maintaining the integrity of the tear film and deficiency in the tear film lipid layer (TFLL) is the cause of evaporative dry eye (EDE) in approximately 80% of dry eye disease patients, resulting in excessive evaporation (so-called hyperevaporative dry eye). This study protocol was designed to assess and compare the effects of intense pulsed light (IPL), heated eye mask (HEM), vectored thermal pulsation system (VTPS), and eyelid massage device (EMD) for improving signs and symptoms of EDE. EDE patients will be randomly divided into IPL, HEM, VTPS, and EMD groups and will be followed up for four weeks. The primary outcome measure will be non-invasive tear breakup time (NITBUT). The secondary outcome measures will include, tear film lipid layer score (TFLL), meibomian gland function and secretion quality change from baseline conjunctival and cornea staining (CFS) with fluorescein and lissamine, tear meniscus height (TMH), conjunctival hyperemia (RS score) and ocular surface disease index (OSDI) questionnaire. Additionally, adverse events also were monitored and documented.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
116

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

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

June 20, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 28, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

October 10, 2023

Status Verified

June 1, 2023

Enrollment Period

2 months

First QC Date

June 20, 2023

Last Update Submit

October 7, 2023

Conditions

Dry Eye

Keywords

dry eyeintense pulsed lightheated eye maskeyepeacelipiflow

Outcome Measures

Primary Outcomes (1)

  • Non-invasive tear breakup time (NITBUT)

    Non-invasive initial tear film breaking time will be assessed using the Keratograph 5M (Oculus, Germany) topographer. Three sequential readings will be captured, and the median value will be included in the final analysis. The median value will be recorded

    • Changes at day-14, day-28 and day-42will be compare with baseline measurements. • Comparison between groups at baseline, day-14, day-28 and day-42will also be examined.

Secondary Outcomes (7)

  • Tear Film Lipid Layer Score (TFLL)

    • Changes at day-14, day-28 and day-42will be compare with baseline measurements. • Comparison between groups at baseline, day-14, day-28 and day-42will also be examined.

  • Meibomian gland function and secretion quality

    • Changes at day-14, day-28 and day-42will be compare with baseline measurements. • Comparison between groups at baseline, day-14, day-28 and day-42will also be examined.

  • Ocular Surface Disease Index (OSDI)

    • Changes at day-14, day-28 and day-42will be compare with baseline measurements. • Comparison between groups at baseline, day-14, day-28 and day-42will also be examined.

  • Fluorescein and lissamine conjunctival and cornea staining (CFS)

    • Changes at day-14, day-28 and day-42will be compare with baseline measurements. • Comparison between groups at baseline, day-14, day-28 and day-42will also be examined.

  • Tear meniscus height (TMH)

    • Changes at day-14, day-28 and day-42will be compare with baseline measurements. • Comparison between groups at baseline, day-14, day-28 and day-42will also be examined.

  • +2 more secondary outcomes

Study Arms (4)

Group A: IPL group

EXPERIMENTAL

participants will receive IPL treatment with 12 homogeneously spaced pulses of light to both eyes at day 0, day 14, and day 28

Device: IPL

Group B: HEM group

EXPERIMENTAL

participants were applied an air-activated disposable eye mask on both closed eyes (Ocuface Medical Co., Ltd., Guangzhou, China) simultaneously for 15 minutes according to the manufacturer's instructions every day for 42 days

Device: Heated eye mask

Group C: VTPS group

EXPERIMENTAL

VTPS group, Patients will receive a single 12-minute treatment using the LipiFlow® (TearScience Inc., Morrisville, NC) on both eyes at day 0

Device: LipiFlow®

Group D: EyePeace® group

EXPERIMENTAL

Participants were followed immediately by 10 gentle squeezes of the eyelid massage device (EMD) on both eyes, and 10 gentle eyelid massaging movements using the index and middle fingers every day for 42 days.

Device: EyePeace®

Interventions

IPLDEVICE

IPL treatment intensity was chosen based on the Fitzpatrick scale as follows: Fitzpatrick scale I, II, III, 10-15 J/cm2 with a 570-nm filter

Group A: IPL group
Heated eye maskDEVICE

Heated eye mask will be used to assess its usefulness in dry eye signs and symptoms

Group B: HEM group
LipiFlow®DEVICE

LipiFlow® can control the variables of temperature, pressure, and MG expression technique

Group C: VTPS group
EyePeace®DEVICE

The silicone-made flexible hand-held gadget applies regulated, vertical pressure to the closed eyelids.

Group D: EyePeace® group

Eligibility Criteria

Age18 Years - 90 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 (a) the ocular surface disease index (OSDI) questionnaire ≥ 13, (b) a non-invasive tear film breakup time (NITBUT) of ≤10 s, or a conjunctivocorneal staining score (CS) of ≥ 3 points. The presence of two or more criteria was used to establish a positive DE diagnosis, based on the 2016 Asia Dry Eye Society criteria
  • Lipid layer thickness score evaluation ≥ 2.

You may not qualify if:

  • existing ocular trauma, infectious diseases, recent surgical history
  • skin defects, pigmentation, moles, scars in the treatment area, skin cancer
  • autoimmune diseases, skin allergies
  • pregnancy or lactation
  • photophobia that may cause reflex tearing or difficulty in evaluating the patient's lipid layer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (14)

  • 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

  • Zhang X, Wang L, Zheng Y, Deng L, Huang X. Prevalence of dry eye disease in the elderly: A protocol of systematic review and meta-analysis. Medicine (Baltimore). 2020 Sep 11;99(37):e22234. doi: 10.1097/MD.0000000000022234.

    PMID: 32925801BACKGROUND

  • Wu MF, Gao H, Zhao LJ, Chen H, Huang YK. Real dynamic assessment of tear film optical quality for monitoring and early prevention of dry eye. Medicine (Baltimore). 2020 Jul 31;99(31):e21494. doi: 10.1097/MD.0000000000021494.

    PMID: 32756182BACKGROUND

  • Fu J, Chou Y, Hao R, Jiang X, Liu Y, Li X. Evaluation of ocular surface impairment in meibomian gland dysfunction of varying severity using a comprehensive grading scale. Medicine (Baltimore). 2019 Aug;98(31):e16547. doi: 10.1097/MD.0000000000016547.

    PMID: 31374018BACKGROUND

  • 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

  • Song Y, Yu S, He X, Yang L, Wu Y, Qin G, Zhang Q, Deep Singh Talwar G, Xu L, Moore JE, He W, Pazo EE. Tear film interferometry assessment after intense pulsed light in dry eye disease: A randomized, single masked, sham-controlled study. Cont Lens Anterior Eye. 2022 Aug;45(4):101499. doi: 10.1016/j.clae.2021.101499. Epub 2021 Aug 22.

    PMID: 34433517BACKGROUND

  • Ikonne EU, Ikpeazu VO, Ugbogu EA. The potential health benefits of dietary natural plant products in age related eye diseases. Heliyon. 2020 Jul 10;6(7):e04408. doi: 10.1016/j.heliyon.2020.e04408. eCollection 2020 Jul.

    PMID: 32685729BACKGROUND

  • Matsumoto Y, Dogru M, Goto E, Ishida R, Kojima T, Onguchi T, Yagi Y, Shimazaki J, Tsubota K. Efficacy of a new warm moist air device on tear functions of patients with simple meibomian gland dysfunction. Cornea. 2006 Jul;25(6):644-50. doi: 10.1097/01.ico.0000208822.70732.25.

    PMID: 17077654BACKGROUND

  • Xu L, Wu Y, Song Y, Zhang Q, Qin G, Yang L, Ma J, Palme C, Moore JE, Pazo EE, He W. Comparison Between Heated Eye Mask and Intense Pulsed Light Treatment for Contact Lens-Related Dry Eye. Photobiomodul Photomed Laser Surg. 2022 Mar;40(3):189-197. doi: 10.1089/photob.2021.0094.

    PMID: 35298282BACKGROUND

  • Wu Y, Xu L, Song Y, Zhang Q, Qin G, Yang L, Ma J, Palme C, Moore JE, Pazo EE, He W. Management of Post-LASIK Dry Eye with Intense Pulsed Light in Combination with 0.1% Sodium Hyaluronate and Heated Eye Mask. Ophthalmol Ther. 2022 Feb;11(1):161-176. doi: 10.1007/s40123-021-00418-2. Epub 2021 Nov 6.

    PMID: 34741758BACKGROUND

  • 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

  • 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

  • Chen J, Qin G, Yu S, Moore J, Xu L, He W, Pazo EE, He X. Comparison of non-pharmaceutical treatments for evaporative dry eye: a randomised controlled study protocol. BMJ Open. 2024 Feb 26;14(2):e078727. doi: 10.1136/bmjopen-2023-078727.

    PMID: 38413161DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

  • Emmanuel Eric Pazo

    He eye specialist hospital

    STUDY CHAIR

Central Study Contacts

Emmanuel Eric Pazo

CONTACT

+8618612782131ericpazo@outlook.com

Jiayan Chen

CONTACT

+8618304019060chenjiayan@hsyk.com.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2023

First Posted

June 28, 2023

Study Start

November 1, 2023

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

October 10, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will share

The study's findings will be shared regardless of the effect's direction. All possible beneficiaries of the research, including patients, carers, family, doctors, advisory boards, and medical boards, will receive trial data. Publications in high impact, open-access medical journals and talks at national and international medical conferences will serve this purpose.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
The Steering Committee will write and submit the report for publication at the end of the study