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

Shenzhen Hospital of Southern Medical University

Status and phase: Unknown; Phase 3

Conditions: MGD-Meibomian Gland Dysfunction; Dry Eye

Treatments: Other: Placebo; Other: Meibomian gland massage; Drug: 0.3% sodium hyaluronate ophthalmic solution; Drug: 0.1% sodium bromide solution

Study type: Interventional

Funder types: Other

Identifiers

NCT03515187

LC2016YM017

Details and patient eligibility

About

A multicenter randomized controlled trial on prevention and treatment of ocular surface injury and meibomian gland dysfunction in patients using anti-glaucoma eye drops.

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 4 patient groups, including a placebo group

A1 Medicine treatment group

Experimental group

Description:

0.3%sodium hyaluronate ophthalmic solution + 0.1 sodium bromide solution, 28 days

Treatment:

Drug: 0.3% sodium hyaluronate ophthalmic solution

Drug: 0.1% sodium bromide solution

A2 Combined treatment group

Experimental group

Description:

0.3%sodium hyaluronate ophthalmic solution + 0.1 sodium bromide solution，with meibomian gland massage , 28 days

Treatment:

Drug: 0.3% sodium hyaluronate ophthalmic solution

Drug: 0.1% sodium bromide solution

Other: Meibomian gland massage

B1 Control group

Placebo Comparator group

Description:

Placebo

Treatment:

Other: Placebo

B2 Experiment group

Experimental group

Description:

0.3%sodium hyaluronate ophthalmic solution, 12 months

Treatment:

Drug: 0.3% sodium hyaluronate ophthalmic solution