Study Results
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Basic Information
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COMPLETED
NA
360 participants
INTERVENTIONAL
2023-03-01
2023-07-01
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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IPL+
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.
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.
Diquafosol tetrasodium
3% Diquafosol tetrasodium eye drops will be used to assess its usefulness in dry eye signs and symptoms
IPL
IPL treatment sessions were administered once at 2- weeks interval to all participants for 4 weeks.
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.
DQS
DQS group will be administered one drop of 3% DQS (Diquas, Santen Pharmaceutical Co., Ltd., Osaka, Japan) six times per day for 4 weeks.
Diquafosol tetrasodium
3% Diquafosol tetrasodium eye drops will be used to assess its usefulness in dry eye signs and symptoms
Interventions
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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.
Diquafosol tetrasodium
3% Diquafosol tetrasodium eye drops will be used to assess its usefulness in dry eye signs and symptoms
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
* 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.
18 Years
90 Years
ALL
No
Sponsors
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He Eye Hospital
OTHER
Responsible Party
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Principal Investigators
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Emmanuel Eric Pazo, MD, PhD
Role: STUDY_CHAIR
He Eye Hospital, Shenyang, China
Locations
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He Eye Hospital
Shenyang, Liaoning, China
Countries
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References
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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.
Bron 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.
Bron 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.
Chhadva 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.
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.
Raulin C, Greve B, Grema H. IPL technology: a review. Lasers Surg Med. 2003;32(2):78-87. doi: 10.1002/lsm.10145.
Heymann 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.
Liu 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.
Baumler 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.
Jeng 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.
Cao 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.
Chen 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.
Pazo 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.
Kulkarni 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.
Dota 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.
Jumblatt JE, Jumblatt MM. Regulation of ocular mucin secretion by P2Y2 nucleotide receptors in rabbit and human conjunctiva. Exp Eye Res. 1998 Sep;67(3):341-6. doi: 10.1006/exer.1998.0520.
Tanioka H, Kuriki Y, Sakamoto A, Katsuta O, Kawazu K, Nakamura M. Expression of the P2Y(2) receptor on the rat ocular surface during a 1-year rearing period. Jpn J Ophthalmol. 2014 Nov;58(6):515-21. doi: 10.1007/s10384-014-0342-4. Epub 2014 Sep 2.
Cowlen MS, Zhang VZ, Warnock L, Moyer CF, Peterson WM, Yerxa BR. Localization of ocular P2Y2 receptor gene expression by in situ hybridization. Exp Eye Res. 2003 Jul;77(1):77-84. doi: 10.1016/s0014-4835(03)00068-x.
Chen J, Qin G, Li L, Qi Y, Che H, Huang H, Xia Y, Zhang Q, Wu Y, Yang L, Moutari S, Moore JE, Xu L, He W, Yu S, Pazo EE, He X. Protocol for a parallel assignment prospective, randomised, comparative trial to evaluate the safety and efficacy of intense pulsed light (IPL) combined with 3% diquafosol (DQS) ophthalmic solution in dry eye syndrome. BMJ Open. 2023 Aug 29;13(8):e073055. doi: 10.1136/bmjopen-2023-073055.
Chen J, Qin G, Li L, Qi Y, Xia Y, Zhang Q, Wu Y, You Y, Yang L, Guo N, Moutari S, Moore JE, Bu S, Xu L, He W, Yu S, Pazo EE, He X. The Combined Impact of Intense Pulsed Light Combined and 3% Diquafosol Ophthalmic Solution on Evaporative Dry Eye: A Randomized Control Study. Ophthalmol Ther. 2023 Dec;12(6):2959-2971. doi: 10.1007/s40123-023-00784-z. Epub 2023 Aug 17.
Other Identifiers
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IPLDQS2023
Identifier Type: -
Identifier Source: org_study_id
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