Dry Eye Disease (DED)Phase 4NCT06860659
Efficacy of 0.28% Sodium Hyaluronate Eye Drops in Patient With Moderate to Severe Dry Eye
A Phase 4 study testing 0.28% Sodium Hyaluronate , preservative free eye drops and 0.18% Sodium Hyaluronate , preservative free eye drops in people with Dry Eye Disease (DED) and Tear Break-Up Time, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Disease (DED), Tear Break-Up Time, Tear Disorder
- What is being tested?
- 0.28% Sodium Hyaluronate , preservative free eye drops and 0.18% Sodium Hyaluronate , preservative free eye drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteThailand
- Study dates
- 1 Sep 2024to 26 Jun 2025
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site
Rajavithi Hospital, 2, Phayathai Road, Ratchathewi District
Bangkok, Bangkok, 10400
About this study
Official title: Efficacy of 0.28% Sodium Hyaluronate Eye Drops in Patient With Moderate to Severe Dry Eye : A Randomized Double-blind Controlled Trial
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.
- Conditions
- Dry Eye Disease (DED), Tear Break-Up Time, Tear Disorder, Tear Film Insufficiency, Tear Film Hyperosmolarity, Dry Eye
- Being tested
- 0.28% Sodium Hyaluronate , preservative free eye drops, 0.18% Sodium Hyaluronate , preservative free eye drops
- Keywords
- tear osmolarity, artificial tears, oxford grading scale, DEQS-TH
- Medical subject headings
- Dry Eye Syndromes, Xerophthalmia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.28% Sodium Hyaluronate , preservative free eye dropsDrug
0.28% Sodium Hyaluronate , preservative free eye drops
0.18% Sodium Hyaluronate , preservative free eye dropsDrug
0.18% Sodium Hyaluronate , preservative free eye drops
| Study group | Role | What they receive |
|---|---|---|
| Vismax | Experimental | 0.28% Sodium Hyaluronate , preservative free eye drops Receives: Drug: 0.28% Sodium Hyaluronate , preservative free eye drops |
| Vislube | Active comparator | 0.18% Sodium Hyaluronate , preservative free eye drops Receives: Drug: 0.18% Sodium Hyaluronate , preservative free eye drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 60 minutes
Secondary outcomes (3)
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.
Measured: 0 minutes, 60 minutes, and 30 days.
To assess dry eye symptoms following the administration of 0.28% Sodium Hyaluronate
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.
Measured: 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.
Measured: 0 minutes and 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start1 Sep 2024
- Primary completion26 May 2025 (estimated)
- Study completion26 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Dry Eye Disease (DED)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Department of Medical Services Ministry of Public Health of Thailand
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Pornlada Sunlakaviset, MD., Principal investigator, Department of Medical Services Ministry of Public Health of Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06860659
- Sponsor's protocol ID
- 67046
- Status last verified
- Mar 2025
- First submitted
- 18 Feb 2025
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient data cannot be disclosed to other researchers because prior consent was not obtained from the patients.
Publications
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.
PubMed 34454466Pattanaphesaj 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.
PubMed 29958008Prabhasawat 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.
PubMed 16973668Troiano 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.
PubMed 19034126Park 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.
PubMed 27929721You 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.
PubMed 30036099Salzillo 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.
PubMed 27561497Ang 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.
PubMed 28827614Lopez-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.
PubMed 27243353Moschos 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.
PubMed 21529354Balazs EA. Hyaluronan as an ophthalmic viscoelastic device. Curr Pharm Biotechnol. 2008 Aug;9(4):236-8. doi: 10.2174/138920108785161596.
PubMed 18691081Shimmura 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.
PubMed 8534643Craig 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.
PubMed 28797892Buchholz 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.
PubMed 16900272Wolffsohn 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.
PubMed 28736342