Efficacy of 0.28% Sodium Hyaluronate Eye Drops in Patient with Moderate to Severe Dry Eye
NCT ID: NCT06860659
Last Updated: 2025-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ENROLLING_BY_INVITATION
PHASE4
84 participants
INTERVENTIONAL
2024-09-01
2025-06-26
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of Preservative-free Low-dose Hyaluronic Acid-containing Salt Solution on Dry Eye Disease
NCT03888183
Efficacy of 0.38% and 0.18% Sodium Hyaluronate Ocular Lubricants for Dry Eye in Adult Gazan Participants
NCT06851364
Sodium Hyaluronate and Wavefront Aberrations in Dry Eyes
NCT01363414
Phase III Confirmatory Study of DE-089 Ophthalmic Solution in Patients With Dry Eye
NCT01240382
Sodium Hyaluronate Ophthalmic Solution, 0.18% for Treatment of Dry Eye Syndrome
NCT01382225
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Additionally, the nurse will prepare a medication for the patient to take home. TearLAB specialists measured and recorded tear osmolarity before instillation in all cases for 10 minutes, and at 30 and 60 minutes post-instillation. Ophthalmologists evaluated TBUT, ocular surface staining (Oxford grading scale), and the Schirmer I test before instillation for 5 minutes and assessed adverse reactions up to 60 minutes after instillation. Subjects continued treatment for 30 days and were reevaluated during the second visit for OSDI scores, TBUT, the Oxford grading scale, and adverse events.
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Vismax
0.28% Sodium Hyaluronate , preservative free eye drops
0.28% Sodium Hyaluronate , preservative free eye drops
0.28% Sodium Hyaluronate , preservative free eye drops
Vislube
0.18% Sodium Hyaluronate , preservative free eye drops
0.18% Sodium Hyaluronate , preservative free eye drops
0.18% Sodium Hyaluronate , preservative free eye drops
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
0.28% Sodium Hyaluronate , preservative free eye drops
0.28% Sodium Hyaluronate , preservative free eye drops
0.18% Sodium Hyaluronate , preservative free eye drops
0.18% Sodium Hyaluronate , preservative free eye drops
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Ocular Surface Disease Index (OSDI) more than or equal 23
* Oxford grading scale more than or equal 2 (both eye)
* Fluorescein tear break-up time less than 7 seconds (both eyes)
* Willing to being a subject in research.
Exclusion Criteria
* History of Ocular surgery in previous 3 months or Refractive surgery in previous 6 months
* History of ocular trauma, infection, ocular inflammation which is not involved with dry eye in previous 3 months
* Wear contact lenses
* Allergic to Sodium hyaluronate
* Pregnant or lactation period
* Diagnosed with physical diseases that affect the eyes and cannot yet be controlled, such as uncontrolled DM (Diabetes Mellitus), active autoimmune disease, and systemic neuropathy induced neurotrophic keratopathy. - Continuous use of medications for diseases such as Retinoic acid derivatives, Antihistamines, Cholinergic agents, and Antipsychotic agents which can lead to chronic dry eye
* Incompleted data.
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Department of Medical Services Ministry of Public Health of Thailand
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pornlada Sunlakaviset, MD.
Role: PRINCIPAL_INVESTIGATOR
Department of Medical Services Ministry of Public Health of Thailand
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Rajavithi Hospital, 2, Phayathai Road, Ratchathewi District
Bangkok, Bangkok, Thailand
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Tansanguan S, Tananuvat N, Wongpakaran N, Wongpakaran T, Ausayakhun S. Thai version of the dry eye-related quality-of-life score questionnaire: preliminary assessment for psychometric properties. BMC Ophthalmol. 2021 Aug 28;21(1):310. doi: 10.1186/s12886-021-02077-0.
Pattanaphesaj J, Thavorncharoensap M, Ramos-Goni JM, Tongsiri S, Ingsrisawang L, Teerawattananon Y. The EQ-5D-5L Valuation study in Thailand. Expert Rev Pharmacoecon Outcomes Res. 2018 Oct;18(5):551-558. doi: 10.1080/14737167.2018.1494574. Epub 2018 Jul 6.
Prabhasawat P, Tesavibul N, Kasetsuwan N. Performance profile of sodium hyaluronate in patients with lipid tear deficiency: randomised, double-blind, controlled, exploratory study. Br J Ophthalmol. 2007 Jan;91(1):47-50. doi: 10.1136/bjo.2006.097691. Epub 2006 Sep 14.
Troiano P, Monaco G. Effect of hypotonic 0.4% hyaluronic acid drops in dry eye patients: a cross-over study. Cornea. 2008 Dec;27(10):1126-30. doi: 10.1097/ICO.0b013e318180e55c.
Park Y, Song JS, Choi CY, Yoon KC, Lee HK, Kim HS. A Randomized Multicenter Study Comparing 0.1%, 0.15%, and 0.3% Sodium Hyaluronate with 0.05% Cyclosporine in the Treatment of Dry Eye. J Ocul Pharmacol Ther. 2017 Mar;33(2):66-72. doi: 10.1089/jop.2016.0086. Epub 2016 Dec 8.
You IC, Li Y, Jin R, Ahn M, Choi W, Yoon KC. Comparison of 0.1%, 0.18%, and 0.3% Hyaluronic Acid Eye Drops in the Treatment of Experimental Dry Eye. J Ocul Pharmacol Ther. 2018 Oct;34(8):557-564. doi: 10.1089/jop.2018.0032. Epub 2018 Jul 23.
Salzillo R, Schiraldi C, Corsuto L, D'Agostino A, Filosa R, De Rosa M, La Gatta A. Optimization of hyaluronan-based eye drop formulations. Carbohydr Polym. 2016 Nov 20;153:275-283. doi: 10.1016/j.carbpol.2016.07.106. Epub 2016 Jul 29.
Ang BCH, Sng JJ, Wang PXH, Htoon HM, Tong LHT. Sodium Hyaluronate in the Treatment of Dry Eye Syndrome: A Systematic Review and Meta-Analysis. Sci Rep. 2017 Aug 21;7(1):9013. doi: 10.1038/s41598-017-08534-5.
Lopez-de la Rosa A, Pinto-Fraga J, Blazquez Arauzo F, Urbano Rodriguez R, Gonzalez-Garcia MJ. Safety and Efficacy of an Artificial Tear Containing 0.3% Hyaluronic Acid in the Management of Moderate-to-Severe Dry Eye Disease. Eye Contact Lens. 2017 Nov;43(6):383-388. doi: 10.1097/ICL.0000000000000284.
Moschos MM, Chatziralli IP, Sergentanis TN. Viscoat versus Visthesia during phacoemulsification cataract surgery: corneal and foveal changes. BMC Ophthalmol. 2011 Apr 29;11:9. doi: 10.1186/1471-2415-11-9.
Balazs EA. Hyaluronan as an ophthalmic viscoelastic device. Curr Pharm Biotechnol. 2008 Aug;9(4):236-8. doi: 10.2174/138920108785161596.
Shimmura S, Ono M, Shinozaki K, Toda I, Takamura E, Mashima Y, Tsubota K. Sodium hyaluronate eyedrops in the treatment of dry eyes. Br J Ophthalmol. 1995 Nov;79(11):1007-11. doi: 10.1136/bjo.79.11.1007.
Craig JP, Nelson JD, Azar DT, Belmonte C, Bron AJ, Chauhan SK, de Paiva CS, Gomes JAP, Hammitt KM, Jones L, Nichols JJ, Nichols KK, Novack GD, Stapleton FJ, Willcox MDP, Wolffsohn JS, Sullivan DA. TFOS DEWS II Report Executive Summary. Ocul Surf. 2017 Oct;15(4):802-812. doi: 10.1016/j.jtos.2017.08.003. Epub 2017 Aug 8.
Buchholz P, Steeds CS, Stern LS, Wiederkehr DP, Doyle JJ, Katz LM, Figueiredo FC. Utility assessment to measure the impact of dry eye disease. Ocul Surf. 2006 Jul;4(3):155-61. doi: 10.1016/s1542-0124(12)70043-5.
Wolffsohn JS, Arita R, Chalmers R, Djalilian A, Dogru M, Dumbleton K, Gupta PK, Karpecki P, Lazreg S, Pult H, Sullivan BD, Tomlinson A, Tong L, Villani E, Yoon KC, Jones L, Craig JP. TFOS DEWS II Diagnostic Methodology report. Ocul Surf. 2017 Jul;15(3):539-574. doi: 10.1016/j.jtos.2017.05.001. Epub 2017 Jul 20.
Rolando M, Cantera E, Mencucci R, Rubino P, Aragona P. The correct diagnosis and therapeutic management of tear dysfunction: recommendations of the P.I.C.A.S.S.O. board. Int Ophthalmol. 2018 Apr;38(2):875-895. doi: 10.1007/s10792-017-0524-4. Epub 2017 Apr 10.
Aragona P, Di Stefano G, Ferreri F, Spinella R, Stilo A. Sodium hyaluronate eye drops of different osmolarity for the treatment of dry eye in Sjogren's syndrome patients. Br J Ophthalmol. 2002 Aug;86(8):879-84. doi: 10.1136/bjo.86.8.879.
Fraser JR, Laurent TC, Laurent UB. Hyaluronan: its nature, distribution, functions and turnover. J Intern Med. 1997 Jul;242(1):27-33. doi: 10.1046/j.1365-2796.1997.00170.x.
Sahai A, Malik P. Dry eye: prevalence and attributable risk factors in a hospital-based population. Indian J Ophthalmol. 2005 Jun;53(2):87-91. doi: 10.4103/0301-4738.16170.
Bron AJ, Evans VE, Smith JA. Grading of corneal and conjunctival staining in the context of other dry eye tests. Cornea. 2003 Oct;22(7):640-50. doi: 10.1097/00003226-200310000-00008.
Dalzell MD. Dry eye: prevalence, utilization, and economic implications. Manag Care. 2003 Dec;12(12 Suppl):9-13.
McCarty CA, Bansal AK, Livingston PM, Stanislavsky YL, Taylor HR. The epidemiology of dry eye in Melbourne, Australia. Ophthalmology. 1998 Jun;105(6):1114-9. doi: 10.1016/S0161-6420(98)96016-X.
Lekhanont K, Rojanaporn D, Chuck RS, Vongthongsri A. Prevalence of dry eye in Bangkok, Thailand. Cornea. 2006 Dec;25(10):1162-7. doi: 10.1097/01.ico.0000244875.92879.1a.
Related Links
Access external resources that provide additional context or updates about the study.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
67046
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.