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

Rajavithi Hospital

Status and phase

Invitation-only

Phase 4

Conditions

Tear Disorder

Tear Film Hyperosmolarity

Tear Film Insufficiency

Quality of Life

Dry Eye

Tear Break-Up Time

Dry Eye Disease (DED)

Hyaluronic Acid

Corneal Staining

Hyaluronate

Treatments

Drug: 0.18% Sodium Hyaluronate , preservative free eye drops

Drug: 0.28% Sodium Hyaluronate , preservative free eye drops

Study type

Interventional

Funder types

Other

Identifiers

NCT06860659

67046

Details and patient eligibility

About

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.

Enrollment

84 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.