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

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03515187
• Other study ID #: LC2016YM017
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: June 2018
• Est. completion date: October 2021

Study information

• Verified date: April 2018
• Source: Shenzhen Hospital of Southern Medical University
• Contact: Yingli Li
• Phone: +81-18124783057
• Email: liyingli333[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Glaucoma
• Keratoconjunctivitis Sicca
• MGD-Meibomian Gland Dysfunction

Intervention

Drug:
• 0.3% sodium hyaluronate ophthalmic solution
one to two drops in eye, four times per day
• 0.1% sodium bromide solution
one to two drops in eye, twice per day

Other:
• Meibomian gland massage
Physiotherapy
• Placebo
Vehicle

Locations

Country	Name	City	State
China	Yingli Li	Shenzhen	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Shenzhen Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

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.