Dry Eye, MGD-Meibomian Gland Dysfunction
Conditions
Keywords
Dug induced dry eye, meibomian gland dysfunction, MGD, Sodium hyaluronate ophthalmic solution, Sodium bromide hydrate eye drops, Meibomian gland massage
Brief summary
A multicenter randomized controlled trial on prevention and treatment of ocular surface injury and meibomian gland dysfunction in patients using anti-glaucoma eye drops.
Detailed description
1\. To compare the efficacy of drug therapy (sodium hyaluronate + sodium bromide) and combined therapy (combined with meibomian gland massage based on drug therapy) on drug-induced dry eye caused by long-term use of anti glaucoma drugs; 2. To evaluate the efficacy of sodium hyaluronate in the prevention of ocular surface and meibomian gland dysfunction and structural damage in the early stage of patients using anti glaucoma eye drops.
Interventions
DRUG0.3% sodium hyaluronate ophthalmic solution
one to two drops in eye, four times per day
DRUG0.1% sodium bromide solution
one to two drops in eye, twice per day
OTHERMeibomian gland massage
Physiotherapy
OTHERPlacebo
Vehicle
Sponsors
Shenzhen Hospital of Southern Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* 18-80 years of age, diagnosed with glaucoma, including primary open-angle glaucoma or primary angle closure glaucoma, require treatment with anti-glaucoma eye drops. * A group: Patients using glaucoma eye drops longer than 6 months, and in accordance with the diagnostic criteria of dry eye: 1. Subjective symptoms (required): dryness, foreign body sensation, fatigue and discomfort; 2. The instability of tear film (required): tear break up time (TBUT); 3. Lacrimal secretion: Schirmer I test; 4. The ocular surface damage (strengthen diagnosis): fluorescein staining (FL); in the mentioned in ①+②（TBUT≤5s) or ①+②（TBUT≤10s)+③（\<10mm）/④（FL+）。 * The choice of study eyes: Choose the eye of the patient with low basical intraocular pressure, and if the basal intraocular pressure is the same, choose the right eye for the study. * Voluntary participation in this clinical study, and signed informed consent.
Exclusion criteria
* With metabolic diseases, autoimmune diseases, connective tissue diseases, such as diabetes, rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosus, Sjogren's syndrome eat; * Combined with cerebrovascular, liver, kidney, hematopoietic serious system desease, atumor diseases and psychosis. * Using any artificial tears and except any clinical trials of dry eyes within two weeks. * With drug therapy, embolization and surgical treatment of dry eyes. * With other eye diseases, such as eyelid defects, hypophasis, pterygium, chronic dacryocystitis, trichiasis, corneal lesions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Ocular Surface Disease Index (OSDI) score | At screening, 1 month and 2 months for treatment. | Primary indicator |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Tear break up time (TBUT) | At screening, 1 month and 2 months for treatment. | Secondary indicator |
| Change from baseline in corneal staining scores | At screening, 1 month and 2 months for treatment. | Secondary indicator |
| Change from baseline in schirmer test | At screening, 1 month and 2 months for treatment. | Secondary indicator |
Other
| Measure | Time frame | Description |
|---|---|---|
| Intraocular pressure | At screening, 1 month and 2 months for treatment. | Additional indicator |
| Change from baseline in number of blocked meibomian glands | At screening, 1 month and 2 months for treatment. | Additional indicator |
Countries
China
Contacts
Primary ContactYingli Li
Backup ContactXinhua Xi
Outcome results
None listed