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Dry EyeNCT05923528

Comparison of Non-pharmaceutical Treatments for Evaporative Dry Eye

A study testing IPL, Heated eye mask and LipiFlow® in people with Dry Eye, run by He Eye Hospital.

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 The sponsor has not verified this record for over two years, so it may be out of date.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
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Dry Eye
What is being tested?
IPL, Heated eye mask and LipiFlow®
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
116 participants
Where
No sites listed yet
Study dates
1 Nov 2023to 31 Dec 2023
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 90 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 (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.

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet.

Emmanuel Eric Pazo contact

+8618612782131

ericpazo@outlook.com

Jiayan Chen contact

+8618304019060

chenjiayan@hsyk.com.cn

About this study

Official title: Comparison of Non-pharmaceutical Treatments for Evaporative Dry Eye: A Randomized Controlled Study

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.

Read the detailed description

"A chronic, diffuse abnormality of the meibomian glands, frequently characterized by terminal duct obstruction and/or qualitative/quantitative abnormalities in glandular secretion," is how the International Workshop on meibomian gland (MG) hypofunction or dysfunction (MGD) describes MGD. These glands, which are repurposed sebaceous glands, secrete meibum onto the ocular surface. By improving the quality and quantity of meibum secretion, signs and symptoms of evaporative dry eye (EDE) and MGD can be alleviated.

Traditional remedies derived from natural sources have been utilized for treating anterior eye ailments since ancient times, predating the advent of contemporary pharmacological interventions. These remedies continue to be employed in diverse populations globally. The objective of this study is to examine the present non-pharmacological modalities that have been implemented and evaluate their efficacy. This encompasses alternative medicine, extant non-pharmaceutical therapeutic modalities, as well as contemporary low and high technological interventions. The most common approaches to relieving MGD involve the application of heat to the eyelids with and without physical massage of the eyelids in order to express the MGs.

Conditions
Dry Eye
Being tested
IPL, Heated eye mask, LipiFlow®, EyePeace®
Keywords
dry eye, intense pulsed light, heated eye mask, eyepeace, lipiflow
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.

  • 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

  • Heated eye maskDevice

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

  • LipiFlow®Device

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

  • EyePeace®Device

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

Study groups in NCT05923528
Study groupRoleWhat they receive
Group A: IPL groupExperimentalparticipants will receive IPL treatment with 12 homogeneously spaced pulses of light to both eyes at day 0, day 14, and day 28
Receives: Device: IPL
Group B: HEM groupExperimentalparticipants 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
Receives: Device: Heated eye mask
Group C: VTPS groupExperimentalVTPS group, Patients will receive a single 12-minute treatment using the LipiFlow® (TearScience Inc., Morrisville, NC) on both eyes at day 0
Receives: Device: LipiFlow®
Group D: EyePeace® groupExperimentalParticipants 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.
Receives: Device: EyePeace®

What is being measured

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

  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

    Measured: • 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)

  1. Tear Film Lipid Layer Score (TFLL)

    Tear film lipid layer interferometry will be assessed using DR-1 (Kowa, Nagoya, Japan). The results will be graded as follows: grade 1, somewhat gray color, uniform distribution; grade 2, somewhat gray color, nonuniform distribution; grade 3, a few colors, nonuniform distribution; grade 4, many colors, nonuniform distribution; grade 5, corneal surface partially exposed

    Measured: • 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. Meibomian gland function and secretion quality

    Five meibomian glands 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: • 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.

  3. Ocular Surface Disease Index (OSDI)

    The patient will answer each question on a scale ranging from 0 to 4, with 0 indicating 'none of the time' and 4 indicating 'all of the time'. If a certain question is deemed irrelevant, it will be marked as 'not applicable (N/A)' and excluded from the analysis. The OSDI total score is calculated according to the following formula. The scale ranges from 0 to 100, with higher scores representing more severe cases of dry eye syndrome

    Measured: • 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.

  4. Fluorescein and lissamine conjunctival and cornea staining (CFS)

    Fluorescein and lissamine staining of the ocular surface will be divided into three zones comprising nasal conjunctival, corneal, and temporal conjunctival areas. The staining score ranged from 0 to 3 for each zone, yielding a total score of 0-9 for the ocular surface

    Measured: • 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.

  5. Tear meniscus height (TMH)

    Non-invasive first tear film breakup time using the Keratograph 5M (Oculus, Germany) topographer will be measured three times consecutively and the median value was recorded

    Measured: • 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.

  6. 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 (normal) to 4.0 (severe)

    Measured: • 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.

  7. Thermal imaging: Ocular surface temperature (OST)

    All measurements were taken in the same room with controlled temperature and humidity. Prior to ocular thermography or other tests, participants were acclimatized to the room for 20 minutes. Morgan and colleagues described the following criteria for recording OST: The patients were instructed to blink normally, close their eyes for 3 seconds, and the first image was captured soon after the eyelids opened. The temperature was taken in the central cornea, which was defined as a circular area 4 mm in diameter in the middle of the cornea

    Measured: • 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.

Timeline

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

  1. First posted28 Jun 2023
  2. Study start1 Nov 2023 (estimated)
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion31 Dec 2023 (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
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
116 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05923528
Sponsor's protocol ID
TREATDE2023
Status last verified
Jun 2023
First submitted
20 Jun 2023
Last updated
10 Oct 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

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

  • 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.

    PubMed 32925801

  • 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.

    PubMed 32756182

  • 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.

    PubMed 31374018

  • 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

  • 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.

    PubMed 34433517

  • 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.

    PubMed 32685729

  • 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.

    PubMed 17077654

  • 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.

    PubMed 35298282

  • 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.

    PubMed 34741758

  • 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

  • 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

  • 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.

    PubMed 38413161

Questions about this trial

What is this clinical trial studying?

A study testing IPL, Heated eye mask and LipiFlow® in people with Dry Eye, run by He Eye Hospital.

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 4 inclusion and 5 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 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

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 Pazo (+8618612782131, 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 breakup time (NITBUT) (time frame: • 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.). 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 NCT05923528, which also lists 14 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 10 Oct 2023.

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