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

• Status: Unknown status
• Trial end date: 2021-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Shenzhen Hospital of Southern Medical University
• Treatments: Bromides; Hyaluronic Acid; Ophthalmic Solutions; Pharmaceutical Solutions

Criteria

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.