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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

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
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-INR-17011399
Enrollment
Unknown
Registered
2017-05-14
Start date
2017-10-02
Completion date
Unknown
Last updated
2017-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry eye & MGD

Interventions

A1 Medicine Treatment Group:0.3%sodium hyaluronate ophthalmic solution + 0.1 sodium bromide solution, 28 days
A2 Conbined Treatment Group:0.3% sodium hyaluronate ophthalmic solution + 0.1 sodium bromide solution, with meibomian gland massage, 28 days
B1 Contral Group:placebo
B2 Experimental Group:0.3% sodium hyaluronate ophthalmic solution, 1 year

Sponsors

Shenzhen Hospital of Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-80 years, diagnosed with glaucoma, including primary open-angle glaucoma or primary angle closure glaucoma, require treatment with anti-glaucoma eye drops; 2. group A: 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+); 3. 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; 4. Voluntary participation in this clinical study, and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. With metabolic diseases, autoimmune diseases, connective tissue diseases, such as diabetes, rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosus, Sjogren's syndrome ect; 2. Combined with cerebrovascular, liver, kidney, hematopoietic serious system desease, atumor diseases and psychosis; 3. Using any artificial tears and except any clinical trials of dry eyes within two weeks; 4. With drug therapy, embolization and surgical treatment of dry eyes; 5. With other eye diseases, such as eyelid defects, hypophasis, pterygium, chronic dacryocystitis, trichiasis, corneal lesions.

Design outcomes

Primary

MeasureTime frame
TBUT;Schirmer Test;Corneal staining scores;Ocular Surface Disease Index(OSDI);

Secondary

MeasureTime frame
conjunctival congestion;eyelid edge change;the nature of meibomain gland section;

Countries

China

Contacts

Public ContactYingli Li

Shenzhen Hospital of Southern Medical University

liyingli333@qq.com+86 18124783057

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026