Back to resultsStudy on Prevention and Treatment of Dry Eye in Patients Using Glaucoma Drops
Primary Purpose
Dry Eye, MGD-Meibomian Gland Dysfunction
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
0.3% sodium hyaluronate ophthalmic solution
0.1% sodium bromide solution
Meibomian gland massage
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye focused on measuring Dug induced dry eye, meibomian gland dysfunction, MGD, Sodium hyaluronate ophthalmic solution, Sodium bromide hydrate eye drops, Meibomian gland massage
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:
- Subjective symptoms (required): dryness, foreign body sensation, fatigue and discomfort;
- The instability of tear film (required): tear break up time (TBUT);
- Lacrimal secretion: Schirmer I test;
- 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.
Sites / Locations
- Yingli Li
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Placebo Comparator
Experimental
Arm Label
A1 Medicine treatment group
A2 Combined treatment group
B1 Control group
B2 Experiment group
Arm Description
0.3%sodium hyaluronate ophthalmic solution + 0.1 sodium bromide solution, 28 days
0.3%sodium hyaluronate ophthalmic solution + 0.1 sodium bromide solution，with meibomian gland massage , 28 days
Placebo
0.3%sodium hyaluronate ophthalmic solution, 12 months
Outcomes
Primary Outcome Measures
Change from baseline in Ocular Surface Disease Index (OSDI) score
Primary indicator
Secondary Outcome Measures
Change from baseline in Tear break up time (TBUT)
Secondary indicator
Change from baseline in corneal staining scores
Secondary indicator
Change from baseline in schirmer test
Secondary indicator
Full Information
NCT ID
NCT03515187
First Posted
May 13, 2017
Last Updated
April 22, 2018
Sponsor
Shenzhen Hospital of Southern Medical University
1. Study Identification
Unique Protocol Identification Number
NCT03515187
Brief Title
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
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 2018 (Anticipated)
Primary Completion Date
April 2021 (Anticipated)
Study Completion Date
October 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shenzhen Hospital of Southern Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A1 Medicine treatment group
Arm Type
Experimental
Arm Description
0.3%sodium hyaluronate ophthalmic solution + 0.1 sodium bromide solution, 28 days
Arm Title
A2 Combined treatment group
Arm Type
Experimental
Arm Description
0.3%sodium hyaluronate ophthalmic solution + 0.1 sodium bromide solution，with meibomian gland massage , 28 days
Arm Title
B1 Control group
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
B2 Experiment group
Arm Type
Experimental
Arm Description
0.3%sodium hyaluronate ophthalmic solution, 12 months
Intervention Type
Drug
Intervention Name(s)
0.3% sodium hyaluronate ophthalmic solution
Intervention Description
one to two drops in eye, four times per day
Intervention Type
Drug
Intervention Name(s)
0.1% sodium bromide solution
Intervention Description
one to two drops in eye, twice per day
Intervention Type
Other
Intervention Name(s)
Meibomian gland massage
Intervention Description
Physiotherapy
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Vehicle
Primary Outcome Measure Information:
Title
Change from baseline in Ocular Surface Disease Index (OSDI) score
Description
Primary indicator
Time Frame
At screening, 1 month and 2 months for treatment.
Secondary Outcome Measure Information:
Title
Change from baseline in Tear break up time (TBUT)
Description
Secondary indicator
Time Frame
At screening, 1 month and 2 months for treatment.
Title
Change from baseline in corneal staining scores
Description
Secondary indicator
Time Frame
At screening, 1 month and 2 months for treatment.
Title
Change from baseline in schirmer test
Description
Secondary indicator
Time Frame
At screening, 1 month and 2 months for treatment.
Other Pre-specified Outcome Measures:
Title
Intraocular pressure
Description
Additional indicator
Time Frame
At screening, 1 month and 2 months for treatment.
Title
Change from baseline in number of blocked meibomian glands
Description
Additional indicator
Time Frame
At screening, 1 month and 2 months for treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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:
Subjective symptoms (required): dryness, foreign body sensation, fatigue and discomfort;
The instability of tear film (required): tear break up time (TBUT);
Lacrimal secretion: Schirmer I test;
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yingli Li
Phone
+81-18124783057
Email
liyingli333@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xinhua Xi
Phone
+81-18025388978
Email
xhxi96@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yingli Li
Organizational Affiliation
Shenzhen Hospital of Southern Medicine University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Min Fu
Organizational Affiliation
Zhejiang Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lang Bai
Organizational Affiliation
Nanfang Hospital, Southern Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Guanghua Zhou
Organizational Affiliation
The Fifth Affiliated Hospital of Southern Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lei Xi
Organizational Affiliation
Guangdong Provincial People's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xiaolin Zhao
Organizational Affiliation
Shenzhen Hospital of Southern Medicine University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wanli Liu
Organizational Affiliation
Shenzhen Hospital of Southern Medicine University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yan Wang
Organizational Affiliation
Shenzhen Hospital of Southern Medicine University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lina Chen
Organizational Affiliation
Shenzhen Hospital of Southern Medicine University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sijing Zhang
Organizational Affiliation
Shenzhen Hospital of Southern Medicine University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shingle An
Organizational Affiliation
Southern Medicine University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Liang Zhang
Organizational Affiliation
Guangdong Provincial People's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ting Meng
Organizational Affiliation
Zhejiang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yingli Li
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518110
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Yingli
Phone
+81-181-2478-3057
Email
liyingli333@qq.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
If we decided to share the individual participants data (IPD), the IPD will be shared with in six months after the clinical trial by loading ResMan(the web-based medical research public management platform- Research manager, ResMan).
Learn more about this trial
Study on Prevention and Treatment of Dry Eye in Patients Using Glaucoma Drops
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