Corneal Staining, Dry Eye, Dry Eye Disease (DED), Hyaluronate, Hyaluronic Acid, Quality of Life, Tear Break-Up Time, Tear Disorder, Tear Film Hyperosmolarity, Tear Film Insufficiency
Conditions
Keywords
tear osmolarity, artificial tears, oxford grading scale, DEQS-TH
Brief 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 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.
Interventions
DRUG0.28% Sodium Hyaluronate , preservative free eye drops
0.28% Sodium Hyaluronate , preservative free eye drops
DRUG0.18% Sodium Hyaluronate , preservative free eye drops
0.18% Sodium Hyaluronate , preservative free eye drops
Sponsors
Department of Medical Services Ministry of Public Health of Thailand
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To examine the effect of 0.28% Sodium Hyaluronate on corneal epithelial healing | 30 days | 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. |
| To examine the effect of 0.28% Sodium Hyaluronate on reducing tear osmolarity | 60 minutes | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 3. To study the stability of the tear film following the administration of 0.28% Sodium Hyaluronate | 0 minutes, 60 minutes, and 30 days. | Fluorescein Tear Break-Up Time (FTBUT) was measured in seconds. Abnormal values are defined as a tear break-up time of ≥ 10 seconds. |
| To assess dry eye symptoms following the administration of 0.28% Sodium Hyaluronate | 0 minutes and 30 days. | 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. |
| To assess quality of life following the administration of 0.28% Sodium Hyaluronate | 0 minutes and 30 days. | 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. |
Countries
Thailand
Outcome results
None listed