Effects of 3% Diquafosol on Tear Film and Vision-related Quality of Life in Orthokeratology Lens Related Dry Eye

NCT06537349 | Not Yet Recruiting

• 1 other identifier: DQS2024
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

Investigate the effect of 3% Diquafosol on tear film and vision-related quality of life in dry eye patients wearing orthokeratology lenses(OK lens), and to provide reference for clinical treatment.This prospective, open label study will include 60 eyes of 30 OK lens related dry eye patients.Participants will receive 3% Diquafosol ophthalmic solution. The dosage for both drugs will be one drop, six times per day for 4 weeks. Pediatric Refractive Error Profiletear(PREP), tear film lipid layer (TFLL),non-invasive breakup time (NITBUT), corneoconjunctival staining score (CS), tear meniscus height (TMH), objective visual quality,ocular surface disease index (OSDI) will be assessed and compared at baseline, day-14, and day-28

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

• Pediatric Refractive Error Profile(PREP) questionnaire score

  Specifically to assess children's vision related quality of life, a total of 26 problem, original score for each from 5 points (positive) to 1 (negative), and then the original score for each minus 1 multiplied by 25, from 100 points (life quality) to 0 rating (poor quality of life), the average score for all 26 PREP problem of. "Strongly disagree" corresponds to 5 points when the statement is reversed.

  Day-0 (baseline), 2-weeks, 4-weeks

Secondary Outcomes (6)

• Non-invasive tear break-up time

  Day-0 (baseline), 2-weeks, 4-weeks

• Tear Film Lipid Layer

  Day-0 (baseline), 2-weeks, 4-weeks

• Conjunctivocorneal staining grade

  Day-0 (baseline), 2-weeks, 4-weeks

• Tear meniscus height

  Day-0 (baseline), 2-weeks, 4-weeks

• Ocular Surface Disease Index(OSDI) questionnaire score

  Day-0 (baseline), 2-weeks, 4-weeks

Study Arms (1)

DQS group

EXPERIMENTAL

Participants in 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: 3% Diquafosol tetrasodium

Interventions

3% Diquafosol tetrasodium DRUG

3% Diquafosol tetrasodium eye drops will be used to assess its usefulness in OK lens related dry eye

Also known as: Diquas

DQS group

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 8-18 years old
• Wearing corneal shape mirror more than one year and at least eight hours every night
• Myopia -5.50 to -1.00 D, astigmatism \< 1.75 D, or curvature between 41.00 and 46.00D, astigmatism \< -0.75D, and best corrected visual acuity ≥1.0.
• Diagnosis of dry eye: patients complained of dry eye, foreign body sensation, burning sensation, fatigue, discomfort, envy, subjective symptom such as vision fluctuation; (a) OSDI questionnaire score \>13 points, and (b) NITBUT \<10 s or (c) ocular surface dyeing assessment \> 5 corneal spots/more than nine conjunctival spots.
• Participants were able to use eye drops as required, complete examinations, and return to the hospital for follow-up examinations within the specified time to complete follow-up.

You may not qualify if:

• Suffering from allergic or autoimmune disease associated with dry eye of the participants are not suitable for wearing OK lens
• Pathological changes in the corneal rim
• Eyelid rim lesions, cornea, uveitis, retina and other systemic diseases may affect the ocular surface. Examples include severe ocular surface diseases (Sjögren's syndrome, allergic conjunctivitis, ocular papules, conjunctival chafing, conjunctival scarring, and chemical damage);
• Received any dry eye treatment within 14 days prior to the start of this study or continued use of other topical eye drops that would affect the results of the study.
• Have received any other eye treatment or surgery

Sponsors & Collaborators

• He Eye Hospital: lead

Related Publications (14)

• Charm J, Cho P. High myopia-partial reduction ortho-k: a 2-year randomized study. Optom Vis Sci. 2013 Jun;90(6):530-9. doi: 10.1097/OPX.0b013e318293657d.

  PMID: 23645372 BACKGROUND

• Chen C, Cheung SW, Cho P. Myopia control using toric orthokeratology (TO-SEE study). Invest Ophthalmol Vis Sci. 2013 Oct 3;54(10):6510-7. doi: 10.1167/iovs.13-12527.

  PMID: 24003088 BACKGROUND

• Kakita T, Hiraoka T, Oshika T. Influence of overnight orthokeratology on axial elongation in childhood myopia. Invest Ophthalmol Vis Sci. 2011 Apr 6;52(5):2170-4. doi: 10.1167/iovs.10-5485.

  PMID: 21212181 BACKGROUND

• Chalmers RL, Young G, Kern J, Napier L, Hunt C. Soft Contact Lens-Related Symptoms in North America and the United Kingdom. Optom Vis Sci. 2016 Aug;93(8):836-47. doi: 10.1097/OPX.0000000000000927.

  PMID: 27391535 BACKGROUND

• Han X, Xu D, Ge W, Wang Z, Li X, Liu W. A Comparison of the Effects of Orthokeratology Lens, Medcall Lens, and Ordinary Frame Glasses on the Accommodative Response in Myopic Children. Eye Contact Lens. 2018 Jul;44(4):268-271. doi: 10.1097/ICL.0000000000000390.

  PMID: 28617728 BACKGROUND

• Li J, Dong P, Liu H. Effect of Overnight Wear Orthokeratology Lenses on Corneal Shape and Tears. Eye Contact Lens. 2018 Sep;44(5):304-307. doi: 10.1097/ICL.0000000000000357.

  PMID: 28060144 BACKGROUND

• Carracedo G, Martin-Gil A, Fonseca B, Pintor J. Effect of overnight orthokeratology on conjunctival goblet cells. Cont Lens Anterior Eye. 2016 Aug;39(4):266-9. doi: 10.1016/j.clae.2016.04.001. Epub 2016 Apr 13.

  PMID: 27085466 BACKGROUND

• Li Y, Kuang K, Yerxa B, Wen Q, Rosskothen H, Fischbarg J. Rabbit conjunctival epithelium transports fluid, and P2Y2(2) receptor agonists stimulate Cl(-) and fluid secretion. Am J Physiol Cell Physiol. 2001 Aug;281(2):C595-602. doi: 10.1152/ajpcell.2001.281.2.C595.

  PMID: 11443059 BACKGROUND

• Ishikawa S, Sasaki T, Maruyama T, Murayama K, Shinoda K. Effectiveness and Adherence of Dry Eye Patients Who Switched from Short- to Long-Acting Diquafosol Ophthalmic Solution. J Clin Med. 2023 Jul 5;12(13):4495. doi: 10.3390/jcm12134495.

  PMID: 37445527 BACKGROUND

• Keating GM. Diquafosol ophthalmic solution 3 %: a review of its use in dry eye. Drugs. 2015 May;75(8):911-22. doi: 10.1007/s40265-015-0409-7.

  PMID: 25968930 BACKGROUND

• Amano S, Inoue K. Effect of topical 3% diquafosol sodium on eyes with dry eye disease and meibomian gland dysfunction. Clin Ophthalmol. 2017 Sep 14;11:1677-1682. doi: 10.2147/OPTH.S148167. eCollection 2017.

  PMID: 29075094 BACKGROUND

• Ji YW, Kim HM, Ryu SY, Oh JW, Yeo A, Choi CY, Kim MJ, Song JS, Kim HS, Seo KY, Kim KP, Lee HK. Changes in Human Tear Proteome Following Topical Treatment of Dry Eye Disease: Cyclosporine A Versus Diquafosol Tetrasodium. Invest Ophthalmol Vis Sci. 2019 Dec 2;60(15):5035-5044. doi: 10.1167/iovs.19-27872.

  PMID: 31800960 BACKGROUND

• Kaido M, Kawashima M, Shigeno Y, Yamada Y, Tsubota K. Randomized Controlled Study to Investigate the Effect of Topical Diquafosol Tetrasodium on Corneal Sensitivity in Short Tear Break-Up Time Dry Eye. Adv Ther. 2018 May;35(5):697-706. doi: 10.1007/s12325-018-0685-1. Epub 2018 Apr 18.

  PMID: 29671255 BACKGROUND

• Yang Y, Wu Q, Tang Y, Wu H, Luo Z, Gao W, Hu Z, Hou L, Wang M, Yang Z, Li X. Short-term application of diquafosol ophthalmic solution benefits children with dry eye wearing orthokeratology lens. Front Med (Lausanne). 2023 Jul 13;10:1130117. doi: 10.3389/fmed.2023.1130117. eCollection 2023.

  PMID: 37521335 BACKGROUND

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Central Study Contacts

Jiayan Chen

CONTACT

18304019060; cjy100009@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: August 5, 2024
• Study Start: August 15, 2024
• Primary Completion: December 15, 2024
• Study Completion: December 31, 2024
• Last Updated: August 12, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share