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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vismax | Experimental | 0.28% Sodium Hyaluronate , preservative free eye drops |
|
| Vislube | Active Comparator | 0.18% Sodium Hyaluronate , preservative free eye drops |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.28% Sodium Hyaluronate , preservative free eye drops | Drug | 0.28% Sodium Hyaluronate , preservative free eye drops |
|
| Measure | Description | Time Frame |
|---|---|---|
| To examine the effect of 0.28% Sodium Hyaluronate on corneal epithelial healing | The Oxford grading scale was used. This scale consists of six levels: 0, I, II, III, IV, and V, with higher values indicating more severe punctate epithelial erosion. | 30 days |
| To examine the effect of 0.28% Sodium Hyaluronate on reducing tear osmolarity | Tear osmolarity was monitored before and after the intervention in both arms. Abnormal Tear Osmolarity is defined as a value of ≥ 308 mOsmol/L, measured using the TearLab® system. | 60 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 3. To study the stability of the tear film following the administration of 0.28% Sodium Hyaluronate | Fluorescein Tear Break-Up Time (FTBUT) was measured in seconds. Abnormal values are defined as a tear break-up time of ≥ 10 seconds. | 0 minutes, 60 minutes, and 30 days. |
| To assess dry eye symptoms following the administration of 0.28% Sodium Hyaluronate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pornlada Sunlakaviset, MD. | Department of Medical Services Ministry of Public Health of Thailand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rajavithi Hospital, 2, Phayathai Road, Ratchathewi District | Bangkok | Bangkok | 10400 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34454466 | Result | 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. | |
| 29958008 | Result | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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Patient data cannot be disclosed to other researchers because prior consent was not obtained from the patients.
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The nurse will randomly assign eligible patients to receive either 0.28% sodium hyaluronate eye drops (Vismax®) or 0.18% sodium hyaluronate eye drops (Vislube®) using a computerized randomsation. The nurse will be the only individual informed of the assigned medication and will be responsible for administering the eye drops to the participants.
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.
| 0.18% Sodium Hyaluronate , preservative free eye drops | Drug | 0.18% Sodium Hyaluronate , preservative free eye drops |
|
The Ocular Surface Disease Index (OSDI) was used. The final score is calculated on a scale from 0 to 100, with higher scores indicating greater severity of ocular surface dysfunction. |
| 0 minutes and 30 days. |
| To assess quality of life following the administration of 0.28% Sodium Hyaluronate | The Dry Eye-Related Quality of Life Score (DEQS-Th) was used. The final score is calculated on a scale from 0 to 100, with higher scores indicating greater severity of ocular surface dysfunction. | 0 minutes and 30 days. |
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| 30036099 | Result | 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. |
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| 27243353 | Result | 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. |
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| 9627665 | Result | 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. |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D014985 | Xerophthalmia |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D003229 | Conjunctival Diseases |
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| ID | Term |
|---|---|
| D006820 | Hyaluronic Acid |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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