Dry Eye Clinical Trial
Official title:
A Multicenter Randomized Controlled Trial on Prevention and Treatment of Ocular Surface Injury and Meibomian Gland Dysfunction in Patients Using Anti-Glaucoma Eye Drops
A multicenter randomized controlled trial on prevention and treatment of ocular surface injury and meibomian gland dysfunction in patients using anti-glaucoma eye drops.
Status | Not yet recruiting |
Enrollment | 160 |
Est. completion date | October 2021 |
Est. primary completion date | April 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
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 ?+?(TBUT=5s) or ?+?(TBUT=10s)+?(<10mm)/?(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. |
Country | Name | City | State |
---|---|---|---|
China | Yingli Li | Shenzhen | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Shenzhen Hospital of Southern Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Intraocular pressure | Additional indicator | At screening, 1 month and 2 months for treatment. | |
Other | Change from baseline in number of blocked meibomian glands | Additional indicator | At screening, 1 month and 2 months for treatment. | |
Primary | Change from baseline in Ocular Surface Disease Index (OSDI) score | Primary indicator | At screening, 1 month and 2 months for treatment. | |
Secondary | Change from baseline in Tear break up time (TBUT) | Secondary indicator | At screening, 1 month and 2 months for treatment. | |
Secondary | Change from baseline in corneal staining scores | Secondary indicator | At screening, 1 month and 2 months for treatment. | |
Secondary | Change from baseline in schirmer test | Secondary indicator | At screening, 1 month and 2 months for treatment. |
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