Study on Prevention and Treatment of Dry Eye in Patients Using Glaucoma Drops
NCT ID: NCT03515187
Last Updated: 2018-05-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
160 participants
INTERVENTIONAL
2018-06-30
2021-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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A1 Medicine treatment group
0.3%sodium hyaluronate ophthalmic solution + 0.1 sodium bromide solution, 28 days
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
A2 Combined treatment group
0.3%sodium hyaluronate ophthalmic solution + 0.1 sodium bromide solution，with meibomian gland massage , 28 days
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
Meibomian gland massage
Physiotherapy
B1 Control group
Placebo
Placebo
Vehicle
B2 Experiment group
0.3%sodium hyaluronate ophthalmic solution, 12 months
0.3% sodium hyaluronate ophthalmic solution
one to two drops in eye, four times per day
Interventions
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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
Meibomian gland massage
Physiotherapy
Placebo
Vehicle
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
80 Years
ALL
Yes
Sponsors
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Shenzhen Hospital of Southern Medical University
OTHER
Responsible Party
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Yingli Li
Principal Investigator
Principal Investigators
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Yingli Li
Role: STUDY_CHAIR
Shenzhen Hospital of Southern Medicine University
Min Fu
Role: PRINCIPAL_INVESTIGATOR
Zhejiang Hospital
Lang Bai
Role: PRINCIPAL_INVESTIGATOR
Nanfang Hospital, Southern Medical University
Guanghua Zhou
Role: PRINCIPAL_INVESTIGATOR
The Fifth Affiliated Hospital of Southern Medical University
Lei Xi
Role: PRINCIPAL_INVESTIGATOR
Guangdong Provincial People's Hospital
Xiaolin Zhao
Role: PRINCIPAL_INVESTIGATOR
Shenzhen Hospital of Southern Medicine University
Wanli Liu
Role: PRINCIPAL_INVESTIGATOR
Shenzhen Hospital of Southern Medicine University
Yan Wang
Role: PRINCIPAL_INVESTIGATOR
Shenzhen Hospital of Southern Medicine University
Lina Chen
Role: PRINCIPAL_INVESTIGATOR
Shenzhen Hospital of Southern Medicine University
Sijing Zhang
Role: PRINCIPAL_INVESTIGATOR
Shenzhen Hospital of Southern Medicine University
Shingle An
Role: PRINCIPAL_INVESTIGATOR
Southern Medicine University
Liang Zhang
Role: PRINCIPAL_INVESTIGATOR
Guangdong Provincial People's Hospital
Ting Meng
Role: PRINCIPAL_INVESTIGATOR
Zhejiang Hospital
Locations
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Yingli Li
Shenzhen, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LC2016YM017
Identifier Type: -
Identifier Source: org_study_id
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