Dry Eye SyndromesNCT04165785
Efficiency and Changes of Cytokines Expression in Tear After Intense Pulsed Light Treating Dry Eye Disease
A study testing OPT IPL and MGX in people with Dry Eye Syndromes, run by First Affiliated Hospital of Harbin Medical University at 1 site in China.
Trial summary
The aim of the current study is to investigate changes of tear cytokines levels as well as the efficacy and the reduction of demodex infestation after OPT IPL treatment in patients with meibomian gland dysfunction-Associated demodicosis. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Dry Eye Syndromes
- What is being tested?
- OPT IPL and MGX
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 20 Aug 2018to 28 Jul 2019
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is able to read, understand and sign an Informed Consent (IC) form
- 18-100 years of age
- Subject is able and willing to comply with the treatment/follow-up (FU) schedule and requirements
- In the study eye, tear break up time ≤ 7 seconds
- In the study eye, Meibomian Gland Score (MGS) ≤ 12
- In the study eye, at least 5 non-atrophied meibomian glands in the lower eyelid
- Symptoms self-assessed using the Ocular Surface Disease Index (OSDI) questionnaire ≥ 23
Who cannot join
- Fitzpatrick skin type V or VI
- Contact lens wear within the month prior to screening
- Unwilling to discontinue use of contact lenses for the duration of the study
- Ocular surgery or eyelid surgery, within 6 months prior to screening
- Neuro-paralysis in the planned treatment area, within 6 months prior to screening
- Other uncontrolled eye disorders affecting the ocular surface, for example active allergies
Show all 33Show fewer
- Current use of punctal plugs
- Pre-cancerous lesions, skin cancer or pigmented lesions in the planned treatment area
- Uncontrolled infections or uncontrolled immunosuppressive diseases
- Subjects with ocular infections, within 6 months prior to screening
- Prior history of cold sores or rashes in the perioral area or in the planned treatment area that could be stimulated by light at a wavelength of 560 nm to 1200 nm, including: Herpes simplex 1 \& 2, Systemic Lupus erythematosus, and porphyria
- Within 3 months prior to screening, use of photosensitive medication and/or herbs that may cause sensitivity to 560-1200 nm light exposure, including: Isotretinoin, Tetracycline, Doxycycline, and St. John's Wort
- Over exposure to sun, within 4 weeks prior to screening
- Use of prescription eye drops for dry eye, within 7 days prior to screening, excluding artificial tears and glaucoma drops
- Radiation therapy to the head or neck, within 12 months prior to screening
- Planned radiation therapy, within 8 weeks after the last treatment session
- Treatment with chemotherapeutic agent, within 8 weeks prior to screening
- Planned chemotherapy, within 8 weeks after the last treatment session
- New topical treatments within the area to be treated, or oral therapies, within 3 months prior to screening- except over-the-counter acetaminophen-based analgesics for pain management, new oral omega 3 fatty acid supplements and topical artificial tears
- Change in dosage of any systemic medication, within 3 months prior to screening
- Anticipated relocation or extensive travel outside of the local study area preventing compliance with follow-up over the study period
- Legally blind in either eye
- History of migraines, seizures or epilepsy
- Facial IPL treatment, within 12 months prior to screening
- Any thermal treatment of the eyelids, including Lipiflow, within 6 months prior to screening
- Expression of the meibomian glands, within 6 months prior to screening
- In either eye, moderate to severe (Grade 3-4) inflammation of the conjunctiva, including: allergic, vernal or giant papillary conjunctivitis
- In either eye, severe (Grade 4) inflammation of the eyelid, including: blepharochalasis, staphylococcal blepharitis or seborrheic blepharitis
- Ocular surface abnormality that may compromise corneal integrity in either eye (e.g., prior chemical burn, recurrent corneal erosion, corneal epithelial defect, Grade 3 corneal fluorescein staining, or map dot fingerprint dystrophy)
- Eyelid abnormalities that affect lid function in either eye, including: entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, and severe ptosis
- Any systemic condition that may cause dry eye disease, including: Stevens-Johnson syndrome, vitamin A deficiency, rheumatoid arthritis, Wegener's granulomatosis, sarcoidosis, leukemia, Riley-Day syndrome, systemic lupus erythematosus, and Sjögren's syndrome
- Unwilling or unable to abstain from the use of medications known to cause dryness (e.g., isotretinoin, antihistamines) throughout the study duration. Subjects must discontinue these medications for at least 1 month prior to the baseline visit.
- Any condition revealed whereby the investigator deems the subject inappropriate for this study
Trial locations and contacts
1 site in 1 country.
China1 site
The First affiliated hospital of harbin medical university
Harbin, Heilongjiang, 150000
About this study
Official title: Efficiency and Changes of Cytokines Expression in Tear After Intense Pulsed Light Treating Evaporated Dry Eye With Demodicosis
The aim of the current study is to investigate changes of tear cytokines levels as well as the efficacy and the reduction of demodex infestation after OPT IPL treatment in patients with meibomian gland dysfunction-Associated demodicosis. The effect of OPT IPL will be examined in a study designed as a randomised controlled trial. In the study arm, subjects will undergo 4 treatment sessions, consisting of OPT IPL pulses immediately followed by meibomian gland expression (MGX). In the control arm, subjects will undergo the same treatments, except that the OPT IPL pulses will be disabled. For each subject, the duration of the study will be 2 months , as explained in the detailed description.
Read the detailed description
All subjects will receive 4 treatments at 2 weeks intervals. In each treatment session, a subject allocated to the study group will be treated with Optimal pulsed technology intense pulsed light (OPT IPL) administered in the malar region, from tragus to tragus including the nose, 2-3 mm below the lower eyelids. Immediately following the OPT IPL administration, the subject will undergo meibomian gland expression (MGX) in both eyelids of both eyes. Subjects in the control arm will receive exactly the same treatment, except that the OPT IPL administration will be sham. A single follow-up will occur at 2 months after the baseline (or 2 weeks after the 4th treatment session). At the follow-up, the changes in the outcome measures will be evaluated, and compared between the two arms.
For each subject, the duration of the study will be 2 months: 1st treatment at baseline; 2nd treatment at 2 weeks after baseline; 3rd treatment at 4 weeks after baseline; 4th treatment at 6 weeks after baseline; and a single follow-up at 8 weeks after baseline).
Statistically significant differences between the two arms will support the study hypothesis that IPL treatment is potentially reduce demodex counts and decrease levels of cytokines , and relief to both signs and symptoms of dry eye disease.
- Conditions
- Dry Eye Syndromes
- Being tested
- OPT IPL, Sham OPT IPL, MGX
- Keywords
- Optimal pulsed technology intense pulsed light, meibomian gland dysfunction, demodicosis, Dry Eye Disease
- Medical subject headings
- Dry Eye Syndromes, Meibomian Gland Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPT IPLDevice
Intense pulsed light (IPL) is a non-invasive and non-laser light treatment that is FDA-approved for various conditions in dermatology. Subjects will receive a total of 4 IPL treatments over the course of the study, at intervals of 2 weeks. Each treatment will include applications of 24 IPL pulses in the malar region and close to the lower eyelids, followed by meibomian gland expression.
Sham OPT IPLDevice
Sham Optimal pulsed technology intense pulsed light IPL will be implemented with an IPL device in which all light is blocked by a filter. Subjects will receive a total of 4 sham treatments over the course of the study, at intervals of 2 weeks. Each treatment will include applications of 24 sham pulses in the malar region and close to the lower eyelids, followed by meibomian gland expression.
MGXProcedure or surgery
Meibomian gland expression (MGX) will be implemented by squeezing the meibomian glands with the aid of stainless steel jaeger lid plate positioned in the inferior fornix space between the tarsal and bulbar conjunctiva, and a cotton swab in another side.
| Study group | Role | What they receive |
|---|---|---|
| OPT IPL followed by MGX | Experimental | Subjects in the experimental arm will receive OPT IPL followed by MGX: OPT IPL pulses will be administered on the skin of the malar region (both cheeks, from tragus to tragus including the nose) and below the lower eyelids. Following OPT IPL therapy, subjects will undergo MGX of both eyelids in both eyes.
Interventions:
Device: IPL Procedure: MGX Receives: Device: OPT IPL; Procedure: MGX |
| Sham OPT IPL followed by MGX | Sham comparator | Subjects in the sham comparator arm will receive Sham OPT IPL followed by MGX: Sham OPT IPL pulses will be administered on the skin of the malar region (both cheeks, from tragus to tragus including the nose) and below the lower eyelids. Following Sham OPT IPL therapy, subjects will undergo MGX of both eyelids in both eyes.
Interventions:
Device: Sham IPL Procedure: MGX Receives: Device: Sham OPT IPL; Procedure: MGX |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of baseline demodex counts
Six lashes with cylindrical dandruff (CD) were epilated from each eye (3 in upper eyelid and 3 in lower eyelid) under slit lamp and mounted on glass slides and were examined under optical microscopy to confirm the presence of D folliculorum. Demodex counts greater than or equal to 1 were Demodex-positive.
Measured: 2 months
change of baseline tear cytokines levels
Change of IL-1α, IL-1β, IL-6, IL-7, IL-12p40, IL-13, IL-17A, IL-8, MMP-3, MMP-9 in the study eye, from baseline to follow-up, in both eyes
Measured: 2 months
Secondary outcomes (7)
Change from baseline of Ocular Surface Disease Index score
The ocular surface disease index score was assessed as a subjective parameter to evaluate the ocular symptoms of dry eye on a score of zero to 100, and subject with a score of greater than 12 was considered abnormal.
Measured: 2 months
change from baseline of schirmer I test
Schirmer I test (without anesthesia) was used to assess tear production by inserting in each eye a sterile dry strip (Jingming, Tianjin, China) into the lateral canthus of the lower eyelid away from the cornea over 5 minutes. The length of the strip that was wetted by absorbed tears was then measured in millimeter to evaluate tear secretion function. Values of less than 7.0 mm are considered a diagnosis of aqueous tear deficiency.
Measured: 2 months
change from baseline of the Lid margin abnormalities score
The slit-lamp biomicroscopy was used to score the lid margin abnormalities: the following four parameters were scored as 0 (absent) or 1 (present) of lid margin abnormalities: lid margin irregularity, plugging of the meibomian orifices, lid margin vascular engorgement, and anterior or posterior replacement of mucocutaneous junction. The sum was recorded as 0-4.
Measured: 2 months
change from baseline of meibum grade score
Meibum grade was assessed in each of eight glands of the central third of the lower lid on a scale of zero to three for each gland: zero (clear), one (cloudy), two (cloudy with debris, granular) and three (thick, like toothpaste). Total score range, 0 to 24
Measured: 2 months
change from baseline of corneal fluorescein staining score
The corneal fluorescein staining score was assessed by instilling fluorescein into the lower conjunctival sac with a fluorescein strip (Jingming, Tianjin, China) moistened with preservative-free saline solution. The grading system recommended by NEI divides the cornea into 5 zones (central, superior, temporal, nasal and inferior). For each zone, the corneal fluorescein staining score was graded on a scale from 0 to 3. Therefore, the maximum score was 15
Measured: 2 months
change of baseline of lashes in vivo confocal microscopy laser
In vivo confocal microscopy laser (IVCM, HRTII Cornea Module; Heidelberg Engineering GmbH, Dossenheim, Germany) was used to examine almost 10-20 eyelashes in both eyes. Demodex folliculorum identified in the infundibulum of the eyelashes and the space adjacent to the eyelash shafts as hypo-reflective elongated bodies with a hyperreflective head. Demodex counts greater than or equal to 1were considered positive.
Measured: 2 months
change from baseline of fluorescein tear break up time
The fluorescein tear beak up time was evaluated immediately after the assessment of staining. The patient was required to blink several times to ensure adequate coating of the dye on the cornea. Using a cobalt blue filter and slit-lamp biomicroscopy, the interval between the last complete blink and appearance of the first dry spot in the stained tear film was recorded as the fluorescein tear beak up time. The test was repeated 3 times and the average fluorescein tear beak up time was calculated in second. Values of less than 10 seconds are considered abnormal.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start20 Aug 2018
- Primary completion28 Jun 2019
- Study completion28 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromesStudies 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
- Model description
- Subjects will be randomized 1:1 to a study arm and a control arm. Subjects in the study arm will be treated with OPT IPL and meibomian gland expression. Subjects in the control arm will be treated with sham OPT IPL and meibomian gland expression.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04165785
- Sponsor's protocol ID
- 198302
- Status last verified
- Oct 2019
- First submitted
- 10 Nov 2019
- Last updated
- 18 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency and Changes of Cytokines Expression in Tear After Intense Pulsed Light Treating Evaporated Dry Eye With Demodicosis
- ClinicalTrials.gov ID
- NCT04165785
- Acronym / sponsor ID
- 198302
- Conditions
- Dry Eye Syndromes
- Keywords
- Optimal pulsed technology intense pulsed light, meibomian gland dysfunction, demodicosis, Dry Eye Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Harbin Medical UniversityUniversity, hospital or other
- Study start
- 20 Aug 2018 (actual)
- Primary completion
- 28 Jun 2019 (actual)
- Study completion
- 28 Jul 2019 (actual)
- First posted
- 18 Nov 2019 (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.
The aim of the current study is to investigate changes of tear cytokines levels as well as the efficacy and the reduction of demodex infestation after OPT IPL treatment in patients with meibomian gland dysfunction-Associated demodicosis. The effect of OPT IPL will be examined in a study designed as a randomised controlled trial. In the study arm, subjects will undergo 4 treatment sessions, consisting of OPT IPL pulses immediately followed by meibomian gland expression (MGX). In the control arm, subjects will undergo the same treatments, except that the OPT IPL pulses will be disabled. For each subject, the duration of the study will be 2 months , as explained in the detailed description.
Detailed description
All subjects will receive 4 treatments at 2 weeks intervals. In each treatment session, a subject allocated to the study group will be treated with Optimal pulsed technology intense pulsed light (OPT IPL) administered in the malar region, from tragus to tragus including the nose, 2-3 mm below the lower eyelids. Immediately following the OPT IPL administration, the subject will undergo meibomian gland expression (MGX) in both eyelids of both eyes. Subjects in the control arm will receive exactly the same treatment, except that the OPT IPL administration will be sham. A single follow-up will occur at 2 months after the baseline (or 2 weeks after the 4th treatment session). At the follow-up, the changes in the outcome measures will be evaluated, and compared between the two arms.
For each subject, the duration of the study will be 2 months: 1st treatment at baseline; 2nd treatment at 2 weeks after baseline; 3rd treatment at 4 weeks after baseline; 4th treatment at 6 weeks after baseline; and a single follow-up at 8 weeks after baseline).
Statistically significant differences between the two arms will support the study hypothesis that IPL treatment is potentially reduce demodex counts and decrease levels of cytokines , and relief to both signs and symptoms of dry eye disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Subjects will be randomized 1:1 to a study arm and a control arm. Subjects in the study arm will be treated with OPT IPL and meibomian gland expression. Subjects in the control arm will be treated with sham OPT IPL and meibomian gland expression.
| Arm | Type | Receives |
|---|---|---|
| OPT IPL followed by MGX | Experimental | Device: OPT IPL, Procedure: MGXSubjects in the experimental arm will receive OPT IPL followed by MGX: OPT IPL pulses will be administered on the skin of the malar region (both cheeks, from tragus to tragus including the nose) and below the lower eyelids. Following OPT IPL therapy, subjects will undergo MGX of both eyelids in both eyes. Interventions: Device: IPL Procedure: MGX |
| Sham OPT IPL followed by MGX | Sham comparator | Device: Sham OPT IPL, Procedure: MGXSubjects in the sham comparator arm will receive Sham OPT IPL followed by MGX: Sham OPT IPL pulses will be administered on the skin of the malar region (both cheeks, from tragus to tragus including the nose) and below the lower eyelids. Following Sham OPT IPL therapy, subjects will undergo MGX of both eyelids in both eyes. Interventions: Device: Sham IPL Procedure: MGX |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject is able to read, understand and sign an Informed Consent (IC) form
- 18-100 years of age
- Subject is able and willing to comply with the treatment/follow-up (FU) schedule and requirements
- In the study eye, tear break up time ≤ 7 seconds
- In the study eye, Meibomian Gland Score (MGS) ≤ 12
Key exclusion criteria (33 listed)
- Fitzpatrick skin type V or VI
- Contact lens wear within the month prior to screening
- Unwilling to discontinue use of contact lenses for the duration of the study
- Ocular surgery or eyelid surgery, within 6 months prior to screening
- Neuro-paralysis in the planned treatment area, within 6 months prior to screening
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 |
|---|---|---|
| OPT IPLIntense pulsed light (IPL) is a non-invasive and non-laser light treatment that is FDA-approved for various conditions in dermatology. Subjects will receive a total of 4 IPL treatments over the course of the study, at intervals of 2 weeks. Each treatment will include applications of 24 IPL pulses in the malar region and close to the lower eyelids, followed by meibomian gland expression. | Device | OPT IPL followed by MGX |
| Sham OPT IPLSham Optimal pulsed technology intense pulsed light IPL will be implemented with an IPL device in which all light is blocked by a filter. Subjects will receive a total of 4 sham treatments over the course of the study, at intervals of 2 weeks. Each treatment will include applications of 24 sham pulses in the malar region and close to the lower eyelids, followed by meibomian gland expression. | Device | Sham OPT IPL followed by MGX |
| MGXMeibomian gland expression (MGX) will be implemented by squeezing the meibomian glands with the aid of stainless steel jaeger lid plate positioned in the inferior fornix space between the tarsal and bulbar conjunctiva, and a cotton swab in another side. | Procedure or surgery | OPT IPL followed by MGX, Sham OPT IPL followed by MGX |
Primary outcome
change of baseline demodex counts
Time frame: 2 months
Six lashes with cylindrical dandruff (CD) were epilated from each eye (3 in upper eyelid and 3 in lower eyelid) under slit lamp and mounted on glass slides and were examined under optical microscopy to confirm the presence of D folliculorum. Demodex counts greater than or equal to 1 were Demodex-positive.
change of baseline tear cytokines levels
Time frame: 2 months
Change of IL-1α, IL-1β, IL-6, IL-7, IL-12p40, IL-13, IL-17A, IL-8, MMP-3, MMP-9 in the study eye, from baseline to follow-up, in both eyes
7 secondary outcomes
Change from baseline of Ocular Surface Disease Index score
Time frame: 2 months
change from baseline of schirmer I test
Time frame: 2 months
change from baseline of the Lid margin abnormalities score
Time frame: 2 months
change from baseline of meibum grade score
Time frame: 2 months
change from baseline of corneal fluorescein staining score
Time frame: 2 months
change of baseline of lashes in vivo confocal microscopy laser
Time frame: 2 months
change from baseline of fluorescein tear break up time
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OPT IPL and MGX in people with Dry Eye Syndromes, run by First Affiliated Hospital of Harbin Medical University 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 7 inclusion and 33 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: finished, as of the sponsor's last update on 18 Nov 2019. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of baseline demodex counts (time frame: 2 months). 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?
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 18 Nov 2019.