Dry EyeNCT05694026
Management of DE With IPL in Combination With DQS
A study testing Intense pulsed light and Diquafosol tetrasodium in people with Dry Eye, run by He Eye Hospital at 1 site in China.
Trial summary
Intense pulsed light (IPL) has been reported to improve signs and symptoms of dry eye (DE). Additionally, meibomian gland secretion of lipids has been observed to improve through the use of IPL. 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?
- Intense pulsed light and Diquafosol tetrasodium
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 1 Jul 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
- Consenting participants
- Able and willing to comply with the treatment/follow-up schedule
- Bilateral signs and symptoms of dry eye disease: (i) Ocular Surface Disease Index (OSDI) questionnaire ≥13, (ii) Non-invasive tear break-up (NITBUT) ≤ 5 seconds, (iii) conjunctival staining score (CS) ≥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
Who cannot join
- A recent history (past 30 days) of topical ophthalmic medication use, including antibiotics, steroids, non-steroidal anti-inflammatory drugs, or required the chronic use of topical ophthalmic medications.
- Eyelids or intraocular tumors.
- Active allergy or infection, or inflammatory disease may prevent the subjects from completing the study at the ocular surface.
- Any structural changes in the lacrimal passage
- Glaucoma
- Diabetes or other systemic, dermatologic, or neurologic diseases that affect the health of the ocular surface.
Show all 9Show fewer
- Use of any systemic anti-inflammatory drugs or medication that may interfere with tear production, such as antianxiety, anti-depressive, and antihistamine medications, within three months.
- Pregnancy or breastfeeding
- Contact lenses wearers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Management of Dry Eye With Intense Pulsed Light in Combination With Diquafosol
Intense pulsed light (IPL) has been reported to improve signs and symptoms of dry eye (DE). Additionally, meibomian gland secretion of lipids has been observed to improve through the use of IPL. Diquafosol ophthalmic solution (DQS) stimulates P2Y2 receptors on the ocular surface, which enhances mucin secretion from goblet cells. Therefore, tear film stability and hydration of the ocular surface can be achieved independent from lacrimal glands function. The purpose of this prospective study was to evaluate and compare the effects of IPL (IPL group), DQS (DQS group) and IPL in combination with DQS (IPL+ group) in participants with persistent DE. Tear film lipid layer (TFLL), non-invasive breakup time (NITBUT), tear meniscus height (TMH), corneoconjunctival staining score (CS), meibum gland (MG) function, conjunctival hyperemia (RS score), ocular surface disease index (OSDI) will be assessed and compared at baseline, day-14, and day-28.
Read the detailed description
Evaporative dry eye (EDE) has been reported to be the most prevalent form of dry eye disease (DED), which is primarily caused by meibomian gland hypofunction or meibomian gland dysfunction (MGD). MGD is defined as ''a chronic, diffuse anomaly of the meibomian glands, often characterized by terminal duct blockage and/or qualitative/quantitative alterations in glandular secretion'' by the International Workshop on MGD.These glands are modified sebaceous glands that release meibum directly onto the ocular surface. Signs and symptoms of EDE and MGD can be addressed by improving the quality and quantity of meibum secretion.
Intense pulsed light (IPL) is widely used to treat dermatological conditions, and its noncoherent polychromatic light source with wide wavelength range of 500-1200 nm has been reported to stimulate facial sebaceous glands. The photothermal effect of IPL is postulated to relieve inflammation by removing aberrant surface microvasculature and enhances meibomian gland function. Furthermore, an increase in fibroblast proliferation, collagen formation and local blood flow has been associated with the application of IPL on the skin. Several studies have documented the benefits of IPL in alleviating signs and symptoms of DED on the periocular skin.
Diquafosol ophthalmic solution (DQS) is a dinucleotide polyphosphate which a purinoceptor agonist, when administered to the ocular surface, it binds to P2Y2 receptors and stimulates mucin and tear secretion. The corneal epithelium, conjunctival epithelium, lacrimal gland ductal epithelium, meibomian gland sebaceous cells, and meibomian gland ductal cells all express the P2Y2 receptor. Subsequently, enhanced secretion of mucin and tear secretion due to DQS ophthalmic solution leads to stabilization of the tear film, minimizes tear evaporation, and reduces mechanical friction thereby protecting the corneal epithelium.
The purpose of this study is to assess the management of DE by combining IPL and DQS eye drops.
- Conditions
- Dry Eye
- Being tested
- Intense pulsed light, Diquafosol tetrasodium
- Keywords
- dry eye, intense pulsed light, diquafosol, tear breakup time, ocular surface disease index
- 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.
Intense pulsed lightDevice
Also called IPL
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.
Diquafosol tetrasodiumDrug
Also called Diquas
3% Diquafosol tetrasodium eye drops will be used to assess its usefulness in dry eye signs and symptoms
| Study group | Role | What they receive |
|---|---|---|
| IPL+ | Experimental | Participants in the IPL+ group used DQS 1 drop 6 times/per day for four weeks along with 2 sessions of IPL, 2 weeks apart. Receives: Device: Intense pulsed light; Drug: Diquafosol tetrasodium |
| IPL | Experimental | IPL treatment sessions were administered once at 2- weeks interval to all participants for 4 weeks. Receives: Device: Intense pulsed light |
| DQS | Experimental | DQS group will be administered one drop of 3% DQS (Diquas, Santen Pharmaceutical Co., Ltd., Osaka, Japan) six times per day for 4 weeks. Receives: Drug: Diquafosol tetrasodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-invasive tear break-up time (NIBUT)
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.
- Changes at day-14 and day-28 will be compare with baseline measurements.
- Comparison between groups at baseline, day-14 and day-28 will also be examined.
Measured: Day-0 (baseline), day-14 and day-28
Ocular Surface Disease Index (OSDI)
OSDI, which is a questionnaire consisting of 12 questions for evaluating the effects of dry eye syndrome on vision, ocular symptoms and any condition associated with DED. 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.
- Changes at day-14 and day-28 will be compare with baseline measurements.
- Comparison between groups at baseline, day-14 and day-28 will also be examined
Measured: Day-0 (baseline), day-14 and day-28
Secondary outcomes (5)
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.
- Changes at day-14 and day-28 will be compare with baseline measurements.
- Comparison between groups at baseline, day-14 and day-28 will also be examined.
Measured: Day-0 (baseline), day-14 and day-28
Meibomian gland function and secretion 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)
- Changes at day-14 and day-28 will be compare with baseline measurements.
- Comparison between groups at baseline, day-14 and day-28 will also be examined.
Measured: Day-0 (baseline), day-14 and day-28
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.
- Changes at day-14 and day-28 will be compare with baseline measurements.
- Comparison between groups at baseline, day-14 and day-28 will also be examined.
Measured: Day-0 (baseline), day-14 and day-28
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.
- Changes at day-14 and day-28 will be compare with baseline measurements.
- Comparison between groups at baseline, day-14 and day-28 will also be examined.
Measured: Day-0 (baseline), day-14 and day-28
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).
- Changes at day-14 and day-28 will be compare with baseline measurements.
- Comparison between groups at baseline, day-14 and day-28 will also be examined.
Measured: Day-0 (baseline), day-14 and day-28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2023
- Study start1 Mar 2023
- Primary completion1 Jul 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- He Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuel Eric Pazo, MD, PhD, Study chair, He Eye Hospital, Shenyang, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05694026
- Sponsor's protocol ID
- IPLDQS2023
- Status last verified
- Jul 2023
- First submitted
- 10 Jan 2023
- Last updated
- 25 Jul 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 32836200Bron 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 28736340Bron AJ, Tiffany JM. The contribution of meibomian disease to dry eye. Ocul Surf. 2004 Apr;2(2):149-65. doi: 10.1016/s1542-0124(12)70150-7.
PubMed 17216085Chhadva P, Goldhardt R, Galor A. Meibomian Gland Disease: The Role of Gland Dysfunction in Dry Eye Disease. Ophthalmology. 2017 Nov;124(11S):S20-S26. doi: 10.1016/j.ophtha.2017.05.031.
PubMed 29055358Craig 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 28736335Raulin C, Greve B, Grema H. IPL technology: a review. Lasers Surg Med. 2003;32(2):78-87. doi: 10.1002/lsm.10145.
PubMed 12561039Heymann WR. Intense pulsed light. J Am Acad Dermatol. 2007 Mar;56(3):466-7. doi: 10.1016/j.jaad.2006.10.031. No abstract available.
PubMed 17317488Liu R, Rong B, Tu P, Tang Y, Song W, Toyos R, Toyos M, Yan X. Analysis of Cytokine Levels in Tears and Clinical Correlations After Intense Pulsed Light Treating Meibomian Gland Dysfunction. Am J Ophthalmol. 2017 Nov;183:81-90. doi: 10.1016/j.ajo.2017.08.021. Epub 2017 Sep 6.
PubMed 28887117Baumler W, Vural E, Landthaler M, Muzzi F, Shafirstein G. The effects of intense pulsed light (IPL) on blood vessels investigated by mathematical modeling. Lasers Surg Med. 2007 Feb;39(2):132-9. doi: 10.1002/lsm.20408.
PubMed 17066482Jeng SF, Chen JA, Chang LR, Chen CC, Shih HS, Chou TM, Chen HF, Feng GM, Yang CH. Beneficial Effect of Intense Pulsed Light on the Wound Healing in Diabetic Rats. Lasers Surg Med. 2020 Jul;52(6):530-536. doi: 10.1002/lsm.23183. Epub 2019 Nov 24.
PubMed 31763712Cao Y, Huo R, Feng Y, Li Q, Wang F. Effects of intense pulsed light on the biological properties and ultrastructure of skin dermal fibroblasts: potential roles in photoaging. Photomed Laser Surg. 2011 May;29(5):327-32. doi: 10.1089/pho.2010.2867. Epub 2011 Mar 25.
PubMed 21438701Chen Y, Li J, Wu Y, Lin X, Deng X, Yun-E Z. Comparative Evaluation in Intense Pulsed Light Therapy Combined with or without Meibomian Gland Expression for the Treatment of Meibomian Gland Dysfunction. Curr Eye Res. 2021 Aug;46(8):1125-1131. doi: 10.1080/02713683.2020.1867750. Epub 2021 Jan 18.
PubMed 33342317Pazo EE, Huang H, Fan Q, Zhang C, Yue Y, Yang L, Xu L, Moore JE, He W. Intense Pulse Light for Treating Post-LASIK Refractory Dry Eye. Photobiomodul Photomed Laser Surg. 2021 Mar;39(3):155-163. doi: 10.1089/photob.2020.4931. Epub 2020 Dec 8.
PubMed 33296261Kulkarni AA, Trousdale MD, Stevenson D, Gukasyan HJ, Shiue MH, Kim KJ, Read RW, Lee VH. Nucleotide-induced restoration of conjunctival chloride and fluid secretion in adenovirus type 5-infected pigmented rabbit eyes. J Pharmacol Exp Ther. 2003 Jun;305(3):1206-11. doi: 10.1124/jpet.103.049221. Epub 2003 Mar 20.
PubMed 12649304Dota A, Sakamoto A, Nagano T, Murakami T, Matsugi T. Effect of Diquafosol Ophthalmic Solution on Airflow-Induced Ocular Surface Disorder in Diabetic Rats. Clin Ophthalmol. 2020 Apr 1;14:1019-1024. doi: 10.2147/OPTH.S242764. eCollection 2020.
PubMed 32280196
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Dry Eye With Intense Pulsed Light in Combination With Diquafosol
- ClinicalTrials.gov ID
- NCT05694026
- Acronym / sponsor ID
- IPLDQS2023
- Conditions
- Dry Eye
- Keywords
- dry eye, intense pulsed light, diquafosol, tear breakup time, ocular surface disease index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- He Eye HospitalUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 23 Jan 2023 (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.
Intense pulsed light (IPL) has been reported to improve signs and symptoms of dry eye (DE). Additionally, meibomian gland secretion of lipids has been observed to improve through the use of IPL. Diquafosol ophthalmic solution (DQS) stimulates P2Y2 receptors on the ocular surface, which enhances mucin secretion from goblet cells. Therefore, tear film stability and hydration of the ocular surface can be achieved independent from lacrimal glands function. The purpose of this prospective study was to evaluate and compare the effects of IPL (IPL group), DQS (DQS group) and IPL in combination with DQS (IPL+ group) in participants with persistent DE. Tear film lipid layer (TFLL), non-invasive breakup time (NITBUT), tear meniscus height (TMH), corneoconjunctival staining score (CS), meibum gland (MG) function, conjunctival hyperemia (RS score), ocular surface disease index (OSDI) will be assessed and compared at baseline, day-14, and day-28.
Detailed description
Evaporative dry eye (EDE) has been reported to be the most prevalent form of dry eye disease (DED), which is primarily caused by meibomian gland hypofunction or meibomian gland dysfunction (MGD). MGD is defined as ''a chronic, diffuse anomaly of the meibomian glands, often characterized by terminal duct blockage and/or qualitative/quantitative alterations in glandular secretion'' by the International Workshop on MGD.These glands are modified sebaceous glands that release meibum directly onto the ocular surface. Signs and symptoms of EDE and MGD can be addressed by improving the quality and quantity of meibum secretion.
Intense pulsed light (IPL) is widely used to treat dermatological conditions, and its noncoherent polychromatic light source with wide wavelength range of 500-1200 nm has been reported to stimulate facial sebaceous glands. The photothermal effect of IPL is postulated to relieve inflammation by removing aberrant surface microvasculature and enhances meibomian gland function. Furthermore, an increase in fibroblast proliferation, collagen formation and local blood flow has been associated with the application of IPL on the skin. Several studies have documented the benefits of IPL in alleviating signs and symptoms of DED on the periocular skin.
Diquafosol ophthalmic solution (DQS) is a dinucleotide polyphosphate which a purinoceptor agonist, when administered to the ocular surface, it binds to P2Y2 receptors and stimulates mucin and tear secretion. The corneal epithelium, conjunctival epithelium, lacrimal gland ductal epithelium, meibomian gland sebaceous cells, and meibomian gland ductal cells all express the P2Y2 receptor. Subsequently, enhanced secretion of mucin and tear secretion due to DQS ophthalmic solution leads to stabilization of the tear film, minimizes tear evaporation, and reduces mechanical friction thereby protecting the corneal epithelium.
The purpose of this study is to assess the management of DE by combining IPL and DQS eye drops.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IPL+ | Experimental | Device: Intense pulsed light, Drug: Diquafosol tetrasodiumParticipants in the IPL+ group used DQS 1 drop 6 times/per day for four weeks along with 2 sessions of IPL, 2 weeks apart. |
| IPL | Experimental | Device: Intense pulsed lightIPL treatment sessions were administered once at 2- weeks interval to all participants for 4 weeks. |
| DQS | Experimental | Drug: Diquafosol tetrasodiumDQS group will be administered one drop of 3% DQS (Diquas, Santen Pharmaceutical Co., Ltd., Osaka, Japan) six times per day for 4 weeks. |
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
- Consenting participants
- Able and willing to comply with the treatment/follow-up schedule
- Bilateral signs and symptoms of dry eye disease: (i) Ocular Surface Disease Index (OSDI) questionnaire ≥13, (ii) Non-invasive tear break-up (NITBUT) ≤ 5 seconds, (iii) conjunctival staining score (CS) ≥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
Key exclusion criteria (9 listed)
- A recent history (past 30 days) of topical ophthalmic medication use, including antibiotics, steroids, non-steroidal anti-inflammatory drugs, or required the chronic use of topical ophthalmic medications.
- Eyelids or intraocular tumors.
- Active allergy or infection, or inflammatory disease may prevent the subjects from completing the study at the ocular surface.
- Any structural changes in the lacrimal passage
- Glaucoma
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 |
|---|---|---|
| Intense pulsed lightAlso: IPLIPL 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 | IPL, IPL+ |
| Diquafosol tetrasodiumAlso: Diquas3% Diquafosol tetrasodium eye drops will be used to assess its usefulness in dry eye signs and symptoms | Drug | DQS, IPL+ |
Primary outcome
Non-invasive tear break-up time (NIBUT)
Time frame: Day-0 (baseline), day-14 and day-28
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. * Changes at day-14 and day-28 will be compare with baseline measurements. * Comparison between groups at baseline, day-14 and day-28 will also be examined.
Ocular Surface Disease Index (OSDI)
Time frame: Day-0 (baseline), day-14 and day-28
OSDI, which is a questionnaire consisting of 12 questions for evaluating the effects of dry eye syndrome on vision, ocular symptoms and any condition associated with DED. 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. * Changes at day-14 and day-28 will be compare with baseline measurements. * Comparison between groups at baseline, day-14 and day-28 will also be examined
5 secondary outcomes
Fluorescein and lissamine conjunctival and cornea staining (CFS)
Time frame: Day-0 (baseline), day-14 and day-28
Meibomian gland function and secretion quality
Time frame: Day-0 (baseline), day-14 and day-28
Tear Film Lipid Layer Score (TFLL)
Time frame: Day-0 (baseline), day-14 and day-28
Tear meniscus height (TMH)
Time frame: Day-0 (baseline), day-14 and day-28
Conjunctival hyperemia (RS score)
Time frame: Day-0 (baseline), day-14 and day-28
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 25 Jul 2023.
- Results publication: PubMed 32836200Ma 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.
- Results publication: 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.
- Results publication: PubMed 17216085Bron AJ, Tiffany JM. The contribution of meibomian disease to dry eye. Ocul Surf. 2004 Apr;2(2):149-65. doi: 10.1016/s1542-0124(12)70150-7.
- Results publication: PubMed 29055358Chhadva P, Goldhardt R, Galor A. Meibomian Gland Disease: The Role of Gland Dysfunction in Dry Eye Disease. Ophthalmology. 2017 Nov;124(11S):S20-S26. doi: 10.1016/j.ophtha.2017.05.031.
- Results publication: PubMed 28736335Craig 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.
- Results publication: PubMed 12561039Raulin C, Greve B, Grema H. IPL technology: a review. Lasers Surg Med. 2003;32(2):78-87. doi: 10.1002/lsm.10145.
- Results publication: PubMed 17317488Heymann WR. Intense pulsed light. J Am Acad Dermatol. 2007 Mar;56(3):466-7. doi: 10.1016/j.jaad.2006.10.031. No abstract available.
- Results publication: PubMed 28887117Liu R, Rong B, Tu P, Tang Y, Song W, Toyos R, Toyos M, Yan X. Analysis of Cytokine Levels in Tears and Clinical Correlations After Intense Pulsed Light Treating Meibomian Gland Dysfunction. Am J Ophthalmol. 2017 Nov;183:81-90. doi: 10.1016/j.ajo.2017.08.021. Epub 2017 Sep 6.
- Results publication: PubMed 17066482Baumler W, Vural E, Landthaler M, Muzzi F, Shafirstein G. The effects of intense pulsed light (IPL) on blood vessels investigated by mathematical modeling. Lasers Surg Med. 2007 Feb;39(2):132-9. doi: 10.1002/lsm.20408.
- Results publication: PubMed 31763712Jeng SF, Chen JA, Chang LR, Chen CC, Shih HS, Chou TM, Chen HF, Feng GM, Yang CH. Beneficial Effect of Intense Pulsed Light on the Wound Healing in Diabetic Rats. Lasers Surg Med. 2020 Jul;52(6):530-536. doi: 10.1002/lsm.23183. Epub 2019 Nov 24.
- Results publication: PubMed 21438701Cao Y, Huo R, Feng Y, Li Q, Wang F. Effects of intense pulsed light on the biological properties and ultrastructure of skin dermal fibroblasts: potential roles in photoaging. Photomed Laser Surg. 2011 May;29(5):327-32. doi: 10.1089/pho.2010.2867. Epub 2011 Mar 25.
- Results publication: PubMed 33342317Chen Y, Li J, Wu Y, Lin X, Deng X, Yun-E Z. Comparative Evaluation in Intense Pulsed Light Therapy Combined with or without Meibomian Gland Expression for the Treatment of Meibomian Gland Dysfunction. Curr Eye Res. 2021 Aug;46(8):1125-1131. doi: 10.1080/02713683.2020.1867750. Epub 2021 Jan 18.
- 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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Sjogren's Syndrome, Salivary Gland
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.
Emmanuel Eric Pazo, MD, PhD study chair
He Eye Hospital, Shenyang, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intense pulsed light and Diquafosol tetrasodium in people with 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 4 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: finished, as of the sponsor's last update on 25 Jul 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?
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?
Non-invasive tear break-up time (NIBUT) (time frame: Day-0 (baseline), day-14 and day-28). 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 NCT05694026, which also lists 20 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 25 Jul 2023.