Management of DE With IPL in Combination With DQS

NCT05694026 | Completed DMC

• 1 other identifier: IPLDQS2023
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Dry Eye

Keywords

dry eye; intense pulsed light; diquafosol; tear breakup time; ocular surface disease index

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  Day-0 (baseline), day-14 and day-28

Secondary Outcomes (5)

• Fluorescein and lissamine conjunctival and cornea staining (CFS)

  Day-0 (baseline), day-14 and day-28

• Meibomian gland function and secretion quality

  Day-0 (baseline), day-14 and day-28

• Tear Film Lipid Layer Score (TFLL)

  Day-0 (baseline), day-14 and day-28

• Tear meniscus height (TMH)

  Day-0 (baseline), day-14 and day-28

• Conjunctival hyperemia (RS score)

  Day-0 (baseline), day-14 and day-28

Study Arms (3)

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.

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.

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.

Drug: Diquafosol tetrasodium

Interventions

Intense pulsed light DEVICE

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.

Also known as: IPL

IPL; IPL+

Diquafosol tetrasodium DRUG

3% Diquafosol tetrasodium eye drops will be used to assess its usefulness in dry eye signs and symptoms

Also known as: Diquas

DQS; IPL+

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• He Eye Hospital: lead

Study Sites (1)

He Eye Hospital

Shenyang, Liaoning, 110034, China

Location

Related Publications (20)

• 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.

  PMID: 32836200 RESULT

• 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.

  PMID: 28736340 RESULT

• 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.

  PMID: 17216085 RESULT

• 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.

  PMID: 29055358 RESULT

• 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.

  PMID: 28736335 RESULT

• Raulin C, Greve B, Grema H. IPL technology: a review. Lasers Surg Med. 2003;32(2):78-87. doi: 10.1002/lsm.10145.

  PMID: 12561039 RESULT

• 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.

  PMID: 17317488 RESULT

• 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.

  PMID: 28887117 RESULT

• 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.

  PMID: 17066482 RESULT

• 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.

  PMID: 31763712 RESULT

• 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.

  PMID: 21438701 RESULT

• 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.

  PMID: 33342317 RESULT

• 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.

  PMID: 33296261 RESULT

• 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.

  PMID: 12649304 RESULT

• 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.

  PMID: 32280196 RESULT

• 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.

  PMID: 9778415 RESULT

• 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.

  PMID: 25179431 RESULT

• 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.

  PMID: 12823990 RESULT

• 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.

  PMID: 37643847 DERIVED

• 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.

  PMID: 37589932 DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Intense Pulsed Light Therapy

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Phototherapy; Therapeutics

Study Officials

• Emmanuel Eric Pazo, MD, PhD

  He Eye Hospital, Shenyang, China

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Masked examiner for all clinical assessments will not involved in the data collection or group allocation procedure for this research. The investigator will not be aware of the three groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2023
• First Posted: January 23, 2023
• Study Start: March 1, 2023
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: July 25, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The Steering Committee will write and submit the report for publication at the end of the study
• Access Criteria: Use in clinical studies

Locations

CN (1)