Dry EyeNCT06269237
Point of Care Test of LTA Level in Tear Fluid, Measured With a POCT Test, in DE Patients Following IPL Treatment
A study testing M22 in people with Dry Eye, run by He Eye Hospital.
Trial summary
To quantify and compare tear levels of Intense pulsed light (IPL) and traditional dry eye clinical tests in dry eye patients before and after Intense pulsed light (IPL) treatment. 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?
- M22
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 22 Feb 2024to 1 Jul 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥ 18 years
- Fitzpatrick skin types I to IV
- capable and willing to comply with the treatment and follow-up obligations
- a determination of DED based on (a) the Ocular Surface Disease Index (OSDI) ≥13 score represents severe DED, (b) non-invasive tear film breakup time (NITBUT) of ≤5 sec, or conjunctivocorneal staining score (CS) ≥3 points according to the Japanese Dry Eye Consensus
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
- Fitzpatrick skin type V or VI.
Trial locations and contacts
No sites are listed yet.
About this study
To quantify and compare tear levels of Intense pulsed light (IPL) and traditional dry eye clinical tests in dry eye patients before and after Intense pulsed light (IPL) treatment.
Read the detailed description
Dry eye is multifactorial, mainly manifested as eye pain, visual impairment (blurred and blurry vision), tear film instability, and tear film hypertonicity, which can cause ocular surface damage. Some possible causes of DED include aging, menopause, Meibomian gland dysfunction (Meibomian gland dysfunction; MGD), Sjogren's syndrome, conjunctival fibrotic disease, refractive surgery, and systemic or topical drugs. Insufficient tear secretion or excessive tear evaporation has been demonstrated to cause precorneal tear concentration or hypertonicity, which disrupts tear film homeostasis. Tear film hypertonicity can cause cell morphological changes, inflammatory cascades, cell death, tear film instability, and further lead to tear hypertonicity. Mgd-induced Evaporative dry eye; EDE) is the most common form of dry eye]. Anti-inflammatory drugs, antibiotics, hot compress, eyelid cleaning and meibomian gland expression are the treatment standards for MGD. However, its long-term efficacy is not satisfactory due to poor patient compliance.
MGD has been found to be associated with eyelid inflammatory disorders. Rosacea affects 5.46% of adults (range 0.09-24.1%) of whom 58% have MGD. Ocular symptoms precede cutaneous rosacea in 15 to 10% of cases, indicating the presence of subclinical variation.
Intense pulsed light (IPL) has mostly been utilized as a dermatological treatment for conditions like facial rosacea, facial erythema, acne, and seborrheic keratosis throughout the last few decades. In 2015, researchers reported the use of IPL for treating MGD to improve the signs and symptoms of DED. Two years later, the TFOS DEWS II report listed IPL as an option for treating DED. Mechanisms of IPL action include liquefication of meibum, regulate inflammation, destroy abnormal blood vessels, inhibit metalloproteinases, and photo modulation. Past studies have reported that IPL treatment modulates tear inflammatory cytokines, with improvements in tear inflammation prior to changes in dry eye signs, however, these studies have been limited by laboratory tests. It is difficult to apply in clinical practice.
Lymphotoxin-alpha (LTA) is a member of the tumor necrosis factor (TNF) superfamily and is expressed by a variety of cells, including T cells, B cells and natural killer cells. LTA secreted to the extracellular space assembles into a homotrimer (LTα3) as a soluble protein, and binds to the tumor necrosis factor receptor to play a role. LTA has been shown to be a diagnostic biomarker for dry eye in past studies. The aim of this study is to investigate the therapeutic mechanism of IPL and provide evidence for the treatment of dry eye by using a point-of-care LTA detection reagent to quantitatively compare the tear LTA levels before and after IPL treatment with traditional dry eye clinical parameters.
- Conditions
- Dry Eye
- Being tested
- M22, sham M22
- Keywords
- dry eye, intense pulsed light, Lymphotoxin alpha
- 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.
M22Device
Participants in the group with 3 sessions of IPL, 2 weeks apart. Device: Intense pulsed light 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.
Other Names:
- IPL
sham M22Device
Participants in the group with 2 sessions of IPL, 1 session of sham IPL, 2 weeks apart. Device: Intense pulsed light 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.
| Study group | Role | What they receive |
|---|---|---|
| IPL | Experimental | Participants in the group with 3 sessions of IPL, 2 weeks apart. Receives: Device: M22 |
| control | Sham comparator | Participants in the group with 2 sessions of IPL, 1 session of sham IPL, 2 weeks apart. Receives: Device: M22; Device: sham M22 |
What is being measured
The primary outcome is the main question the study is designed to answer.
LTA
Lymphotoxin-alpha (LTA) is a member of the tumor necrosisfactor (TNF) superfamily and is expressed by a variety of cells, including T cells, B cells and natural killer cells. LTA secreted to the extracellular space assembles into a homotrimer (LTα3) as a soluble protein [23], and binds to the tumor necrosis factor receptor to play a role. LTA will be measured using an immunochromatography assay by collecting 1ul tear samples from the lateral canthus using a capillary tear collector. To assess the concentration of LTA in the tear samples, a commercial reagent card (S05B, Seinda Biomedical Corporation, Guangdong, China) based on colloidal gold and immunochromatographic analysis was utilized.
Measured: Day-0 (baseline), day-21, day-42, day-63 and day-84
Non-invasive tear break-up time (NITBUT)
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: Day-0 (baseline), day-21, day-42, day-63 and day-84
Secondary outcomes (6)
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. Higher scores means worse.
Measured: Day-0 (baseline), day-21, day-42, day-63 and day-84
Meibomian quality
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: Day-0 (baseline), day-21, day-42, day-63 and day-84
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: Day-0 (baseline), day-21, day-42, day-63 and day-84
Tear meniscus height (TMH)
TMH using the Keratograph 5M (Oculus, Germany) topographer will be measured three times consecutively and the median value was recorded.
Measured: Day-0 (baseline), day-21, day-42, day-63 and day-84
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: Day-0 (baseline), day-21, day-42, day-63 and day-84
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: Day-0 (baseline), day-21, day-42, day-63 and day-84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start22 Feb 2024 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- He Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guanghao Qin, Study chair, He Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06269237
- Sponsor's protocol ID
- 2023LTA
- Status last verified
- May 2023
- First submitted
- 3 Jun 2023
- Last updated
- 21 Feb 2024
- 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
Tsubota K, Yokoi N, Shimazaki J, Watanabe H, Dogru M, Yamada M, Kinoshita S, Kim HM, Tchah HW, Hyon JY, Yoon KC, Seo KY, Sun X, Chen W, Liang L, Li M, Liu Z; Asia Dry Eye Society. New Perspectives on Dry Eye Definition and Diagnosis: A Consensus Report by the Asia Dry Eye Society. Ocul Surf. 2017 Jan;15(1):65-76. doi: 10.1016/j.jtos.2016.09.003. Epub 2016 Oct 8.
PubMed 27725302Schein OD, Munoz B, Tielsch JM, Bandeen-Roche K, West S. Prevalence of dry eye among the elderly. Am J Ophthalmol. 1997 Dec;124(6):723-8. doi: 10.1016/s0002-9394(14)71688-5.
PubMed 9402817Evans V, Millar TJ, Eden JA, Willcox MD. Menopause, hormone replacement therapy and tear function. Adv Exp Med Biol. 2002;506(Pt B):1029-33. doi: 10.1007/978-1-4615-0717-8_145. No abstract available.
PubMed 12614027Valencia-Nieto L, Novo-Diez A, Blanco-Vazquez M, Lopez-Miguel A. Therapeutic Instruments Targeting Meibomian Gland Dysfunction. Ophthalmol Ther. 2020 Dec;9(4):797-807. doi: 10.1007/s40123-020-00304-3. Epub 2020 Sep 24.
PubMed 32968960Kang YS, Lee HS, Li Y, Choi W, Yoon KC. Manifestation of meibomian gland dysfunction in patients with Sjogren's syndrome, non-Sjogren's dry eye, and non-dry eye controls. Int Ophthalmol. 2018 Jun;38(3):1161-1167. doi: 10.1007/s10792-017-0577-4. Epub 2017 May 31.
PubMed 28567496Sambhi RS, Sambhi GDS, Mather R, Malvankar-Mehta MS. Dry eye after refractive surgery: a meta-analysis. Can J Ophthalmol. 2020 Apr;55(2):99-106. doi: 10.1016/j.jcjo.2019.07.005. Epub 2019 Aug 20.
PubMed 31712000Fraunfelder FT, Sciubba JJ, Mathers WD. The role of medications in causing dry eye. J Ophthalmol. 2012;2012:285851. doi: 10.1155/2012/285851. Epub 2012 Aug 27.
PubMed 23050121Askeroglu U, Alleyne B, Guyuron B. Pharmaceutical and herbal products that may contribute to dry eyes. Plast Reconstr Surg. 2013 Jan;131(1):159-167. doi: 10.1097/PRS.0b013e318272a00e.
PubMed 23271525Bron AJ, de Paiva CS, Chauhan SK, Bonini S, Gabison EE, Jain S, Knop E, Markoulli M, Ogawa Y, Perez V, Uchino Y, Yokoi N, Zoukhri D, Sullivan DA. TFOS DEWS II pathophysiology report. Ocul Surf. 2017 Jul;15(3):438-510. doi: 10.1016/j.jtos.2017.05.011. Epub 2017 Jul 20.
PubMed 28736340Thode AR, Latkany RA. Current and Emerging Therapeutic Strategies for the Treatment of Meibomian Gland Dysfunction (MGD). Drugs. 2015 Jul;75(11):1177-85. doi: 10.1007/s40265-015-0432-8.
PubMed 26130187Machalinska A, Zakrzewska A, Markowska A, Safranow K, Wiszniewska B, Parafiniuk M, Machalinski B. Morphological and Functional Evaluation of Meibomian Gland Dysfunction in Rosacea Patients. Curr Eye Res. 2016 Aug;41(8):1029-1034. doi: 10.3109/02713683.2015.1088953. Epub 2015 Dec 7.
PubMed 26644191Tavassoli S, Wong N, Chan E. Ocular manifestations of rosacea: A clinical review. Clin Exp Ophthalmol. 2021 Mar;49(2):104-117. doi: 10.1111/ceo.13900. Epub 2021 Feb 3.
PubMed 33403718Viso E, Rodriguez-Ares MT, Abelenda D, Oubina B, Gude F. Prevalence of asymptomatic and symptomatic meibomian gland dysfunction in the general population of Spain. Invest Ophthalmol Vis Sci. 2012 May 4;53(6):2601-6. doi: 10.1167/iovs.11-9228.
PubMed 22427596Yang L, Pazo EE, Zhang Q, Wu Y, Song Y, Qin G, Zhang H, Li J, Xu L, He W. Treatment of contact lens related dry eye with intense pulsed light. Cont Lens Anterior Eye. 2022 Apr;45(2):101449. doi: 10.1016/j.clae.2021.101449. Epub 2021 Apr 28.
PubMed 33933353Rong B, Tang Y, Liu R, Tu P, Qiao J, Song W, Yan X. Long-Term Effects of Intense Pulsed Light Combined with Meibomian Gland Expression in the Treatment of Meibomian Gland Dysfunction. Photomed Laser Surg. 2018 Oct;36(10):562-567. doi: 10.1089/pho.2018.4499. Epub 2018 Sep 22.
PubMed 30251914
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Point of Care Test of LTA Level in Tear Fluid, Measured With a POCT Test, in DE Patients Following IPL Treatment
- ClinicalTrials.gov ID
- NCT06269237
- Acronym / sponsor ID
- 2023LTA
- Conditions
- Dry Eye
- Keywords
- dry eye, intense pulsed light, Lymphotoxin alpha
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- He Eye HospitalUniversity, hospital or other
- Study start
- 22 Feb 2024 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 21 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To quantify and compare tear levels of Intense pulsed light (IPL) and traditional dry eye clinical tests in dry eye patients before and after Intense pulsed light (IPL) treatment.
Detailed description
Dry eye is multifactorial, mainly manifested as eye pain, visual impairment (blurred and blurry vision), tear film instability, and tear film hypertonicity, which can cause ocular surface damage. Some possible causes of DED include aging, menopause, Meibomian gland dysfunction (Meibomian gland dysfunction; MGD), Sjogren's syndrome, conjunctival fibrotic disease, refractive surgery, and systemic or topical drugs. Insufficient tear secretion or excessive tear evaporation has been demonstrated to cause precorneal tear concentration or hypertonicity, which disrupts tear film homeostasis. Tear film hypertonicity can cause cell morphological changes, inflammatory cascades, cell death, tear film instability, and further lead to tear hypertonicity. Mgd-induced Evaporative dry eye; EDE) is the most common form of dry eye]. Anti-inflammatory drugs, antibiotics, hot compress, eyelid cleaning and meibomian gland expression are the treatment standards for MGD. However, its long-term efficacy is not satisfactory due to poor patient compliance.
MGD has been found to be associated with eyelid inflammatory disorders. Rosacea affects 5.46% of adults (range 0.09-24.1%) of whom 58% have MGD. Ocular symptoms precede cutaneous rosacea in 15 to 10% of cases, indicating the presence of subclinical variation.
Intense pulsed light (IPL) has mostly been utilized as a dermatological treatment for conditions like facial rosacea, facial erythema, acne, and seborrheic keratosis throughout the last few decades. In 2015, researchers reported the use of IPL for treating MGD to improve the signs and symptoms of DED. Two years later, the TFOS DEWS II report listed IPL as an option for treating DED. Mechanisms of IPL action include liquefication of meibum, regulate inflammation, destroy abnormal blood vessels, inhibit metalloproteinases, and photo modulation. Past studies have reported that IPL treatment modulates tear inflammatory cytokines, with improvements in tear inflammation prior to changes in dry eye signs, however, these studies have been limited by laboratory tests. It is difficult to apply in clinical practice.
Lymphotoxin-alpha (LTA) is a member of the tumor necrosis factor (TNF) superfamily and is expressed by a variety of cells, including T cells, B cells and natural killer cells. LTA secreted to the extracellular space assembles into a homotrimer (LTα3) as a soluble protein, and binds to the tumor necrosis factor receptor to play a role. LTA has been shown to be a diagnostic biomarker for dry eye in past studies. The aim of this study is to investigate the therapeutic mechanism of IPL and provide evidence for the treatment of dry eye by using a point-of-care LTA detection reagent to quantitatively compare the tear LTA levels before and after IPL treatment with traditional dry eye clinical parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IPL | Experimental | Device: M22Participants in the group with 3 sessions of IPL, 2 weeks apart. |
| control | Sham comparator | Device: M22, Device: sham M22Participants in the group with 2 sessions of IPL, 1 session of sham IPL, 2 weeks apart. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age ≥ 18 years
- Fitzpatrick skin types I to IV
- capable and willing to comply with the treatment and follow-up obligations
- a determination of DED based on (a) the Ocular Surface Disease Index (OSDI) ≥13 score represents severe DED, (b) non-invasive tear film breakup time (NITBUT) of ≤5 sec, or conjunctivocorneal staining score (CS) ≥3 points according to the Japanese Dry Eye Consensus
Key exclusion criteria (5 listed)
- 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
- Fitzpatrick skin type V or VI.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| M22Participants in the group with 3 sessions of IPL, 2 weeks apart. Device: Intense pulsed light 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. Other Names: • IPL | Device | IPL, control |
| sham M22Participants in the group with 2 sessions of IPL, 1 session of sham IPL, 2 weeks apart. Device: Intense pulsed light 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. | Device | control |
Primary outcome
LTA
Time frame: Day-0 (baseline), day-21, day-42, day-63 and day-84
Lymphotoxin-alpha (LTA) is a member of the tumor necrosisfactor (TNF) superfamily and is expressed by a variety of cells, including T cells, B cells and natural killer cells. LTA secreted to the extracellular space assembles into a homotrimer (LTα3) as a soluble protein [23], and binds to the tumor necrosis factor receptor to play a role. LTA will be measured using an immunochromatography assay by collecting 1ul tear samples from the lateral canthus using a capillary tear collector. To assess the concentration of LTA in the tear samples, a commercial reagent card (S05B, Seinda Biomedical Corporation, Guangdong, China) based on colloidal gold and immunochromatographic analysis was utilized.
Non-invasive tear break-up time (NITBUT)
Time frame: Day-0 (baseline), day-21, day-42, day-63 and day-84
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.
6 secondary outcomes
Fluorescein and lissamine conjunctival and cornea staining (CFS)
Time frame: Day-0 (baseline), day-21, day-42, day-63 and day-84
Meibomian quality
Time frame: Day-0 (baseline), day-21, day-42, day-63 and day-84
Tear Film Lipid Layer Score(TFLL)
Time frame: Day-0 (baseline), day-21, day-42, day-63 and day-84
Tear meniscus height (TMH)
Time frame: Day-0 (baseline), day-21, day-42, day-63 and day-84
Conjunctival hyperemia (RS score)
Time frame: Day-0 (baseline), day-21, day-42, day-63 and day-84
Ocular Surface Disease Index (OSDI)
Time frame: Day-0 (baseline), day-21, day-42, day-63 and day-84
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
- Background: PubMed 27725302Tsubota K, Yokoi N, Shimazaki J, Watanabe H, Dogru M, Yamada M, Kinoshita S, Kim HM, Tchah HW, Hyon JY, Yoon KC, Seo KY, Sun X, Chen W, Liang L, Li M, Liu Z; Asia Dry Eye Society. New Perspectives on Dry Eye Definition and Diagnosis: A Consensus Report by the Asia Dry Eye Society. Ocul Surf. 2017 Jan;15(1):65-76. doi: 10.1016/j.jtos.2016.09.003. Epub 2016 Oct 8.
- Background: PubMed 9402817Schein OD, Munoz B, Tielsch JM, Bandeen-Roche K, West S. Prevalence of dry eye among the elderly. Am J Ophthalmol. 1997 Dec;124(6):723-8. doi: 10.1016/s0002-9394(14)71688-5.
- Background: PubMed 12614027Evans V, Millar TJ, Eden JA, Willcox MD. Menopause, hormone replacement therapy and tear function. Adv Exp Med Biol. 2002;506(Pt B):1029-33. doi: 10.1007/978-1-4615-0717-8_145. No abstract available.
- Background: PubMed 32968960Valencia-Nieto L, Novo-Diez A, Blanco-Vazquez M, Lopez-Miguel A. Therapeutic Instruments Targeting Meibomian Gland Dysfunction. Ophthalmol Ther. 2020 Dec;9(4):797-807. doi: 10.1007/s40123-020-00304-3. Epub 2020 Sep 24.
- Background: PubMed 28567496Kang YS, Lee HS, Li Y, Choi W, Yoon KC. Manifestation of meibomian gland dysfunction in patients with Sjogren's syndrome, non-Sjogren's dry eye, and non-dry eye controls. Int Ophthalmol. 2018 Jun;38(3):1161-1167. doi: 10.1007/s10792-017-0577-4. Epub 2017 May 31.
- Background: PubMed 31712000Sambhi RS, Sambhi GDS, Mather R, Malvankar-Mehta MS. Dry eye after refractive surgery: a meta-analysis. Can J Ophthalmol. 2020 Apr;55(2):99-106. doi: 10.1016/j.jcjo.2019.07.005. Epub 2019 Aug 20.
- Background: PubMed 23050121Fraunfelder FT, Sciubba JJ, Mathers WD. The role of medications in causing dry eye. J Ophthalmol. 2012;2012:285851. doi: 10.1155/2012/285851. Epub 2012 Aug 27.
- Background: PubMed 23271525Askeroglu U, Alleyne B, Guyuron B. Pharmaceutical and herbal products that may contribute to dry eyes. Plast Reconstr Surg. 2013 Jan;131(1):159-167. doi: 10.1097/PRS.0b013e318272a00e.
- Background: PubMed 28736340Bron AJ, de Paiva CS, Chauhan SK, Bonini S, Gabison EE, Jain S, Knop E, Markoulli M, Ogawa Y, Perez V, Uchino Y, Yokoi N, Zoukhri D, Sullivan DA. TFOS DEWS II pathophysiology report. Ocul Surf. 2017 Jul;15(3):438-510. doi: 10.1016/j.jtos.2017.05.011. Epub 2017 Jul 20.
- Background: PubMed 26130187Thode AR, Latkany RA. Current and Emerging Therapeutic Strategies for the Treatment of Meibomian Gland Dysfunction (MGD). Drugs. 2015 Jul;75(11):1177-85. doi: 10.1007/s40265-015-0432-8.
- Background: PubMed 26644191Machalinska A, Zakrzewska A, Markowska A, Safranow K, Wiszniewska B, Parafiniuk M, Machalinski B. Morphological and Functional Evaluation of Meibomian Gland Dysfunction in Rosacea Patients. Curr Eye Res. 2016 Aug;41(8):1029-1034. doi: 10.3109/02713683.2015.1088953. Epub 2015 Dec 7.
- Background: PubMed 33403718Tavassoli S, Wong N, Chan E. Ocular manifestations of rosacea: A clinical review. Clin Exp Ophthalmol. 2021 Mar;49(2):104-117. doi: 10.1111/ceo.13900. Epub 2021 Feb 3.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guanghao Qin study chair
He Eye Hospital
Questions about this trial
What is this clinical trial studying?
A study testing M22 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 21 Feb 2024. 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. Some participants in this study may receive a placebo. 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 Guanghao Qin (+8618842664420, qinguanghao@hsyk.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LTA (time frame: Day-0 (baseline), day-21, day-42, day-63 and day-84). The study lists 2 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 NCT06269237, which also lists 29 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 21 Feb 2024.