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

Phase 3

• Conditions: Dry Eye; MGD-Meibomian Gland Dysfunction
• Interventions: Drug: 0.3% sodium hyaluronate ophthalmic solution; Other: Placebo; Drug: 0.1% sodium bromide solution; Other: Meibomian gland massage

• Registration Number: NCT03515187
• Lead Sponsor: Shenzhen Hospital of Southern Medical University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-05-13
• Status Verified: 2018-04
• Study First Submitted QC: 2018-04-22
• Last Update Submitted: 2018-04-22
• Study First Posted: 2018-05-03
• Last Update Posted: 2018-05-03
• Study Start: 2018-06
• Primary Completion: 2021-04
• Study Completion: 2021-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A1 Medicine treatment group	0.3% sodium hyaluronate ophthalmic solution	0.3%sodium hyaluronate ophthalmic solution + 0.1 sodium bromide solution, 28 days
A1 Medicine treatment group	0.1% sodium bromide solution	0.3%sodium hyaluronate ophthalmic solution + 0.1 sodium bromide solution, 28 days
A2 Combined treatment group	0.3% sodium hyaluronate ophthalmic solution	0.3%sodium hyaluronate ophthalmic solution + 0.1 sodium bromide solution，with meibomian gland massage , 28 days
A2 Combined treatment group	0.1% sodium bromide solution	0.3%sodium hyaluronate ophthalmic solution + 0.1 sodium bromide solution，with meibomian gland massage , 28 days
A2 Combined treatment group	Meibomian gland massage	0.3%sodium hyaluronate ophthalmic solution + 0.1 sodium bromide solution，with meibomian gland massage , 28 days
B1 Control group	Placebo	Placebo
B2 Experiment group	0.3% sodium hyaluronate ophthalmic solution	0.3%sodium hyaluronate ophthalmic solution, 12 months

Primary Outcome Measures

Name	Time	Method
Change from baseline in Ocular Surface Disease Index (OSDI) score	At screening, 1 month and 2 months for treatment.	Primary indicator

Secondary Outcome Measures

Name	Time	Method
Change from baseline in Tear break up time (TBUT)	At screening, 1 month and 2 months for treatment.	Secondary indicator
Change from baseline in corneal staining scores	At screening, 1 month and 2 months for treatment.	Secondary indicator
Change from baseline in schirmer test	At screening, 1 month and 2 months for treatment.	Secondary indicator

Trial Locations

Locations (1)

Yingli Li; 🇨🇳 Shenzhen, Guangdong, China