Trials / Enrolling By Invitation
Enrolling By InvitationNCT06860659
Efficacy of 0.28% Sodium Hyaluronate Eye Drops in Patient With Moderate to Severe Dry Eye
Efficacy of 0.28% Sodium Hyaluronate Eye Drops in Patient With Moderate to Severe Dry Eye : A Randomized Double-blind Controlled Trial
- Status
- Enrolling By Invitation
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 84 (estimated)
- Sponsor
- Department of Medical Services Ministry of Public Health of Thailand · Other Government
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
- Dry Eye Disease (DED)
- Tear Break-Up Time
- Tear Disorder
- Tear Film Insufficiency
- Tear Film Hyperosmolarity
- Dry Eye
- Hyaluronate
- Hyaluronic Acid
- Corneal Staining
- Quality of Life
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 0.28% Sodium Hyaluronate , preservative free eye drops | 0.28% Sodium Hyaluronate , preservative free eye drops |
| DRUG | 0.18% Sodium Hyaluronate , preservative free eye drops | 0.18% Sodium Hyaluronate , preservative free eye drops |
Timeline
- Start date
- 2024-09-01
- Primary completion
- 2025-05-26
- Completion
- 2025-06-26
- First posted
- 2025-03-06
- Last updated
- 2025-03-06
Locations
1 site across 1 country: Thailand
Source: ClinicalTrials.gov record NCT06860659. Inclusion in this directory is not an endorsement.