Efficacy of 0.28% Sodium Hyaluronate Eye Drops in Patient With Moderate to Severe Dry Eye

Официальное название

Efficacy of 0.28% Sodium Hyaluronate Eye Drops in Patient With Moderate to Severe Dry Eye : A Randomized Double-blind Controlled Trial

Обзор

This study aimed to evaluate the efficacy and safety of 0.28% preservative-free SH and 0.18% SH eye drops in patients with dry eye disease. Subjects diagnosed with dry eye disease and meeting the inclusion criteria (Ocular Surface Disease Index (OSDI) score ≥ 23, Fluorescein Tear Breakup Time (TBUT) \< 7 seconds were randomized into two groups. Group 1 (42 eyes) received 0.28% SH, and Group 2 (42 eyes) received 0.18% SH, both administered by a nurse. Measurements included tear osmolarity (TearLAB) before instillation and at 0,30 and 60 minutes post-instillation, recorded by a TearLAB specialist. Ophthalmologists assessed TBUT, ocular surface staining (Oxford grading scale), and the Schirmer I test before instillation and evaluated adverse reactions up to 60 minutes post-instillation. Subjects continued treatment for 30 days and were reevaluated during a second visit for OSDI scores, TBUT, the Oxford grading scale, and adverse events. Quality of life score were assessed at before and after treatment for 1 month.

Вмешательства

• Препарат 0.28% Sodium Hyaluronate , preservative free eye drops
  0.28% Sodium Hyaluronate , preservative free eye drops
• Препарат 0.18% Sodium Hyaluronate , preservative free eye drops
  0.18% Sodium Hyaluronate , preservative free eye drops

Первичные конечные точки

• To examine the effect of 0.28% Sodium Hyaluronate on corneal epithelial healing [Срок оценки: 30 days]
• To examine the effect of 0.28% Sodium Hyaluronate on reducing tear osmolarity [Срок оценки: 60 minutes]

Вторичные конечные точки (3)

• 3. To study the stability of the tear film following the administration of 0.28% Sodium Hyaluronate [Срок оценки: 0 minutes, 60 minutes, and 30 days.]
• To assess dry eye symptoms following the administration of 0.28% Sodium Hyaluronate [Срок оценки: 0 minutes and 30 days.]
• To assess quality of life following the administration of 0.28% Sodium Hyaluronate [Срок оценки: 0 minutes and 30 days.]

Критерии участия

Критерии включения

• Age more than or equal 18 year-old
• 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.

Критерии исключения

• Diagnosed with other eye diseases that require medication which is not used to treat dry eye, such as Glaucoma
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Таиланд · 1 центр

• Rajavithi Hospital, 2, Phayathai Road, Ratchathewi District — Bangkok

Публикации

• 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. PMID 34454466
• 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. PMID 29958008
• 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. PMID 16973668
• 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. PMID 19034126
• 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. PMID 27929721
• 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. PMID 30036099
• 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. PMID 27561497
• 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. PMID 28827614

Идентификаторы

NCT: NCT06860659 · 67046

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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