Clinical trial NCT03515187: Study on Prevention and Treatment of Dry Eye in Patients Using Glaucoma Drops
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Dry Eye
MGD-Meibomian Gland Dysfunction
Keywords: Dug induced dry eye
meibomian gland dysfunction, MGD
Sodium hyaluronate ophthalmic solution
Sodium bromide hydrate eye drops
Meibomian gland massage
Lead sponsor: Shenzhen Hospital of Southern Medical University
Sponsor class: OTHER
First posted: 2018-05-03
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Change from baseline in Ocular Surface Disease Index (OSDI) score
timeFrame: At screening, 1 month and 2 months for treatment.
Secondary outcomes:
measure: Change from baseline in Tear break up time (TBUT)
timeFrame: At screening, 1 month and 2 months for treatment.
measure: Change from baseline in corneal staining scores
timeFrame: At screening, 1 month and 2 months for treatment.
measure: Change from baseline in schirmer test
timeFrame: At screening, 1 month and 2 months for treatment.
Other outcomes:
measure: Intraocular pressure
timeFrame: At screening, 1 month and 2 months for treatment.
measure: Change from baseline in number of blocked meibomian glands
timeFrame: At screening, 1 month and 2 months for treatment.
Locations:
city: Shenzhen
country: China
facility: Yingli Li
state: Guangdong
Study officials:
affiliation: Shenzhen Hospital of Southern Medicine University
name: Yingli Li
role: STUDY_CHAIR
affiliation: Zhejiang Hospital
name: Min Fu
role: PRINCIPAL_INVESTIGATOR
affiliation: Nanfang Hospital, Southern Medical University
name: Lang Bai
role: PRINCIPAL_INVESTIGATOR
affiliation: The Fifth Affiliated Hospital of Southern Medical University
name: Guanghua Zhou
role: PRINCIPAL_INVESTIGATOR
affiliation: Guangdong Provincial People's Hospital
name: Lei Xi
role: PRINCIPAL_INVESTIGATOR
affiliation: Shenzhen Hospital of Southern Medicine University
name: Xiaolin Zhao
role: PRINCIPAL_INVESTIGATOR
affiliation: Shenzhen Hospital of Southern Medicine University
name: Wanli Liu
role: PRINCIPAL_INVESTIGATOR
affiliation: Shenzhen Hospital of Southern Medicine University
name: Yan Wang
role: PRINCIPAL_INVESTIGATOR
affiliation: Shenzhen Hospital of Southern Medicine University
name: Lina Chen
role: PRINCIPAL_INVESTIGATOR
affiliation: Shenzhen Hospital of Southern Medicine University
name: Sijing Zhang
role: PRINCIPAL_INVESTIGATOR
affiliation: Southern Medicine University
name: Shingle An
role: PRINCIPAL_INVESTIGATOR
affiliation: Guangdong Provincial People's Hospital
name: Liang Zhang
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhejiang Hospital
name: Ting Meng
role: PRINCIPAL_INVESTIGATOR
References: