NCT03515187

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2018

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2017

Completed
12 months until next milestone

First Posted

Study publicly available on registry

May 3, 2018

Completed
29 days until next milestone

Study Start

First participant enrolled

June 1, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

May 3, 2018

Status Verified

April 1, 2018

Enrollment Period

2.8 years

First QC Date

May 13, 2017

Last Update Submit

April 22, 2018

Conditions

Dry EyeMGD-Meibomian Gland Dysfunction

Keywords

Dug induced dry eyemeibomian gland dysfunction, MGDSodium hyaluronate ophthalmic solutionSodium bromide hydrate eye dropsMeibomian gland massage

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in Ocular Surface Disease Index (OSDI) score

    Primary indicator

    At screening, 1 month and 2 months for treatment.

Secondary Outcomes (3)

  • Change from baseline in Tear break up time (TBUT)

    At screening, 1 month and 2 months for treatment.

  • Change from baseline in corneal staining scores

    At screening, 1 month and 2 months for treatment.

  • Change from baseline in schirmer test

    At screening, 1 month and 2 months for treatment.

Other Outcomes (2)

  • Intraocular pressure

    At screening, 1 month and 2 months for treatment.

  • Change from baseline in number of blocked meibomian glands

    At screening, 1 month and 2 months for treatment.

Study Arms (4)

A1 Medicine treatment group

EXPERIMENTAL

0.3%sodium hyaluronate ophthalmic solution + 0.1 sodium bromide solution, 28 days

Drug: 0.3% sodium hyaluronate ophthalmic solutionDrug: 0.1% sodium bromide solution

A2 Combined treatment group

EXPERIMENTAL

0.3%sodium hyaluronate ophthalmic solution + 0.1 sodium bromide solution，with meibomian gland massage , 28 days

Drug: 0.3% sodium hyaluronate ophthalmic solutionDrug: 0.1% sodium bromide solutionOther: Meibomian gland massage

B1 Control group

PLACEBO COMPARATOR

Placebo

Other: Placebo

B2 Experiment group

EXPERIMENTAL

0.3%sodium hyaluronate ophthalmic solution, 12 months

Drug: 0.3% sodium hyaluronate ophthalmic solution

Interventions

0.3% sodium hyaluronate ophthalmic solutionDRUG

one to two drops in eye, four times per day

A1 Medicine treatment groupA2 Combined treatment groupB2 Experiment group
0.1% sodium bromide solutionDRUG

one to two drops in eye, twice per day

A1 Medicine treatment groupA2 Combined treatment group
Meibomian gland massageOTHER

Physiotherapy

A2 Combined treatment group
PlaceboOTHER

Vehicle

B1 Control group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yingli Li

Shenzhen, Guangdong, 518110, China

Location

MeSH Terms

Conditions

Dry Eye SyndromesMeibomian Gland Dysfunction

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye DiseasesEyelid Diseases

Study Officials

  • Yingli Li

    Shenzhen Hospital of Southern Medicine University

    STUDY CHAIR

  • Min Fu

    Zhejiang Hospital

    PRINCIPAL INVESTIGATOR

  • Lang Bai

    Nanfang Hospital, 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yingli Li

CONTACT

+81-18124783057liyingli333@qq.com

Xinhua Xi

CONTACT

+81-18025388978xhxi96@163.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 13, 2017

First Posted

May 3, 2018

Study Start

June 1, 2018

Primary Completion

April 1, 2021

Study Completion

October 1, 2021

Last Updated

May 3, 2018

Record last verified: 2018-04

Locations

CN(1)