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

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ClinicalTrials.gov Identifier: NCT03515187
Recruitment Status : Not yet recruiting
First Posted : May 3, 2018
Last Update Posted : May 3, 2018
Sponsor:
Information provided by (Responsible Party):
Yingli Li, 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.

Condition or disease Intervention/treatment Phase
Dry Eye MGD-Meibomian Gland Dysfunction Drug: 0.3% sodium hyaluronate ophthalmic solution Drug: 0.1% sodium bromide solution Other: Meibomian gland massage Other: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Estimated Study Start Date : June 2018
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Experimental: A1 Medicine treatment group
0.3%sodium hyaluronate ophthalmic solution + 0.1 sodium bromide solution, 28 days
Drug: 0.3% sodium hyaluronate ophthalmic solution
one to two drops in eye, four times per day

Drug: 0.1% sodium bromide solution
one to two drops in eye, twice per day

Experimental: A2 Combined treatment group
0.3%sodium hyaluronate ophthalmic solution + 0.1 sodium bromide solution,with meibomian gland massage , 28 days
Drug: 0.3% sodium hyaluronate ophthalmic solution
one to two drops in eye, four times per day

Drug: 0.1% sodium bromide solution
one to two drops in eye, twice per day

Other: Meibomian gland massage
Physiotherapy

Placebo Comparator: B1 Control group
Placebo
Other: Placebo
Vehicle

Experimental: B2 Experiment group
0.3%sodium hyaluronate ophthalmic solution, 12 months
Drug: 0.3% sodium hyaluronate ophthalmic solution
one to two drops in eye, four times per day




Primary Outcome Measures :
  1. Change from baseline in Ocular Surface Disease Index (OSDI) score [ Time Frame: At screening, 1 month and 2 months for treatment. ]
    Primary indicator


Secondary Outcome Measures :
  1. Change from baseline in Tear break up time (TBUT) [ Time Frame: At screening, 1 month and 2 months for treatment. ]
    Secondary indicator

  2. Change from baseline in corneal staining scores [ Time Frame: At screening, 1 month and 2 months for treatment. ]
    Secondary indicator

  3. Change from baseline in schirmer test [ Time Frame: At screening, 1 month and 2 months for treatment. ]
    Secondary indicator


Other Outcome Measures:
  1. Intraocular pressure [ Time Frame: At screening, 1 month and 2 months for treatment. ]
    Additional indicator

  2. Change from baseline in number of blocked meibomian glands [ Time Frame: At screening, 1 month and 2 months for treatment. ]
    Additional indicator



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03515187


Contacts
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Contact: Yingli Li +81-18124783057 liyingli333@qq.com
Contact: Xinhua Xi +81-18025388978 xhxi96@163.com

Locations
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China, Guangdong
Yingli Li Not yet recruiting
Shenzhen, Guangdong, China, 518110
Contact: Li Yingli    +81-181-2478-3057    liyingli333@qq.com   
Sponsors and Collaborators
Shenzhen Hospital of Southern Medical University
Investigators
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Study Chair: Yingli Li Shenzhen Hospital of Southern Medicine University
Principal Investigator: Min Fu Zhejiang Hospital
Principal Investigator: Lang Bai Nanfang Hospital of Southern Medical University
Principal Investigator: Guanghua Zhou The Fifth Affiliated Hospital of Southern Medical University
Principal Investigator: Lei Xi Guangdong Provincial People's Hospital
Principal Investigator: Xiaolin Zhao Shenzhen Hospital of Southern Medicine University
Principal Investigator: Wanli Liu Shenzhen Hospital of Southern Medicine University
Principal Investigator: Yan Wang Shenzhen Hospital of Southern Medicine University
Principal Investigator: Lina Chen Shenzhen Hospital of Southern Medicine University
Principal Investigator: Sijing Zhang Shenzhen Hospital of Southern Medicine University
Principal Investigator: Shingle An Southern Medicine University
Principal Investigator: Liang Zhang Guangdong Provincial People's Hospital
Principal Investigator: Ting Meng Zhejiang Hospital

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Responsible Party: Yingli Li, Principal Investigator, Shenzhen Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT03515187     History of Changes
Other Study ID Numbers: LC2016YM017
First Posted: May 3, 2018    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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).

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yingli Li, Shenzhen Hospital of Southern Medical University:
Dug induced dry eye
meibomian gland dysfunction, MGD
Sodium hyaluronate ophthalmic solution
Sodium bromide hydrate eye drops
Meibomian gland massage
Additional relevant MeSH terms:
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Glaucoma
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Ocular Hypertension
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Bromides
Ophthalmic Solutions
Pharmaceutical Solutions
Hyaluronic Acid
Anticonvulsants
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents