Study on Prevention and Treatment of Dry Eye in Patients Using Glaucoma Drops

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Multicenter Randomized Controlled Trial on Prevention and Treatment of Ocular Surface Injury and Meibomian Gland Dysfunction in Patients Using Anti-Glaucoma Eye Drops

Conditions
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Dry Eye, MGD-Meibomian Gland Dysfunction

Intervention / Treatment
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* Drug: 0.3% sodium hyaluronate ophthalmic solution
* Drug: 0.1% sodium bromide solution
* Other: Meibomian gland massage
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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: Subjective symptoms (required): dryness, foreign body sensation, fatigue and discomfort; The instability of tear film (required): tear break up time (TBUT); Lacrimal secretion: Schirmer I test; 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A1 Medicine treatment group<br>0.3%sodium hyaluronate ophthalmic solution + 0.1 sodium bromide solution, 28 days | Drug: 0.3% sodium hyaluronate ophthalmic solution<br>* one to two drops in eye, four times per day<br>Drug: 0.1% sodium bromide solution<br>* one to two drops in eye, twice per day<br>|
| Experimental: A2 Combined treatment group<br>0.3%sodium hyaluronate ophthalmic solution + 0.1 sodium bromide solution，with meibomian gland massage , 28 days | Drug: 0.3% sodium hyaluronate ophthalmic solution<br>* one to two drops in eye, four times per day<br>Drug: 0.1% sodium bromide solution<br>* one to two drops in eye, twice per day<br>Other: Meibomian gland massage<br>* Physiotherapy<br>|
| Placebo Comparator: B1 Control group<br>Placebo | Other: Placebo<br>* Vehicle<br>|
| Experimental: B2 Experiment group<br>0.3%sodium hyaluronate ophthalmic solution, 12 months | Drug: 0.3% sodium hyaluronate ophthalmic solution<br>* one to two drops in eye, four times per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Ocular Surface Disease Index (OSDI) score | Primary indicator | At screening, 1 month and 2 months for treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Tear break up time (TBUT) | Secondary indicator | At screening, 1 month and 2 months for treatment. | 
| Change from baseline in corneal staining scores | Secondary indicator | At screening, 1 month and 2 months for treatment. | 
| Change from baseline in schirmer test | Secondary indicator | At screening, 1 month and 2 months for treatment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dug induced dry eye, meibomian gland dysfunction, MGD, Sodium hyaluronate ophthalmic solution, Sodium bromide hydrate eye drops, Meibomian gland massage