drugset / Trial / NCT06537349
Effects of 3% Diquafosol on Tear Film and Vision-related Quality of Life in Orthokeratology Lens Related Dry Eye
NaSingle-groupOpen-labelTreatment
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
Timeline
- Start
- 2024-08-15
- Primary completion
- 2024-12-15
- Completion
- 2024-12-31
Publications
- Background 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Diquafosol | Oligonucleotide (other) | 3 % | Topical |