Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE May 13, 2017
First Posted Date  ICMJE May 3, 2018
Last Update Posted Date May 3, 2018
Estimated Study Start Date  ICMJE June 2018
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 22, 2018)
Change from baseline in Ocular Surface Disease Index (OSDI) score [ Time Frame: At screening, 1 month and 2 months for treatment. ]
Primary indicator
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 22, 2018)
  • Change from baseline in Tear break up time (TBUT) [ Time Frame: At screening, 1 month and 2 months for treatment. ]
    Secondary indicator
  • Change from baseline in corneal staining scores [ Time Frame: At screening, 1 month and 2 months for treatment. ]
    Secondary indicator
  • Change from baseline in schirmer test [ Time Frame: At screening, 1 month and 2 months for treatment. ]
    Secondary indicator
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 22, 2018)
  • Intraocular pressure [ Time Frame: At screening, 1 month and 2 months for treatment. ]
    Additional indicator
  • Change from baseline in number of blocked meibomian glands [ Time Frame: At screening, 1 month and 2 months for treatment. ]
    Additional indicator
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Study on Prevention and Treatment of Dry Eye in Patients Using Glaucoma Drops
Official Title  ICMJE A Multicenter Randomized Controlled Trial on Prevention and Treatment of Ocular Surface Injury and Meibomian Gland Dysfunction in Patients Using Anti-Glaucoma Eye Drops
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Dry Eye
  • MGD-Meibomian Gland Dysfunction
Intervention  ICMJE
  • 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
  • Other: Placebo
    Vehicle
Study Arms  ICMJE
  • Experimental: A1 Medicine treatment group
    0.3%sodium hyaluronate ophthalmic solution + 0.1 sodium bromide solution, 28 days
    Interventions:
    • Drug: 0.3% sodium hyaluronate ophthalmic solution
    • Drug: 0.1% sodium bromide solution
  • Experimental: A2 Combined treatment group
    0.3%sodium hyaluronate ophthalmic solution + 0.1 sodium bromide solution,with meibomian gland massage , 28 days
    Interventions:
    • Drug: 0.3% sodium hyaluronate ophthalmic solution
    • Drug: 0.1% sodium bromide solution
    • Other: Meibomian gland massage
  • Placebo Comparator: B1 Control group
    Placebo
    Intervention: Other: Placebo
  • Experimental: B2 Experiment group
    0.3%sodium hyaluronate ophthalmic solution, 12 months
    Intervention: Drug: 0.3% sodium hyaluronate ophthalmic solution
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 22, 2018)
160
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2021
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Yingli Li +81-18124783057 liyingli333@qq.com
Contact: Xinhua Xi +81-18025388978 xhxi96@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03515187
Other Study ID Numbers  ICMJE LC2016YM017
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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).
Responsible Party Yingli Li, Shenzhen Hospital of Southern Medical University
Study Sponsor  ICMJE Shenzhen Hospital of Southern Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Shenzhen Hospital of Southern Medical University
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP