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

A Multicenter Randomized Controlled Trial on Prevention and Treatment of Ocular Surface Injury and Meibomian Gland Dysfunction in Patients Using Anti-Glaucoma Eye Drops

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 Overview

• Status: Unknown
• Conditions: Dry Eye; MGD-Meibomian Gland Dysfunction
• Intervention / Treatment: Other: Placebo; Drug: 0.3% sodium hyaluronate ophthalmic solution; Drug: 0.1% sodium bromide solution; Other: Meibomian gland massage

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: Interventional
• Enrollment (Anticipated): 160
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Yingli Li; Phone Number: +81-18124783057; Email: liyingli333@qq.com
• Study Contact Backup: Name: Xinhua Xi; Phone Number: +81-18025388978; Email: xhxi96@163.com

Study Locations

• China
  • Guangdong
    • Shenzhen, Guangdong, China, 518110
      • Yingli Li
      • Contact: Li Yingli; Phone Number: +81-181-2478-3057; Email: liyingli333@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Tear break up time (TBUT)	Secondary indicator	At screening, 1 month and 2 months for treatment.
Change from baseline in corneal staining scores	Secondary indicator	At screening, 1 month and 2 months for treatment.
Change from baseline in schirmer test	Secondary indicator	At screening, 1 month and 2 months for treatment.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraocular pressure	Additional indicator	At screening, 1 month and 2 months for treatment.
Change from baseline in number of blocked meibomian glands	Additional indicator	At screening, 1 month and 2 months for treatment.

Collaborators and Investigators

• Sponsor: Shenzhen Hospital of Southern Medical University
• Investigators: 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

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2018
• Primary Completion (Anticipated): April 1, 2021
• Study Completion (Anticipated): October 1, 2021

Study Registration Dates

• First Submitted: May 13, 2017
• First Submitted That Met QC Criteria: April 22, 2018
• First Posted (Actual): May 3, 2018

Study Record Updates

• Last Update Posted (Actual): May 3, 2018
• Last Update Submitted That Met QC Criteria: April 22, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Dug induced dry eye; meibomian gland dysfunction, MGD; Sodium hyaluronate ophthalmic solution; Sodium bromide hydrate eye drops; Meibomian gland massage
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eyelid Diseases; Glaucoma; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Meibomian Gland Dysfunction; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Anticonvulsants; Viscosupplements; Ophthalmic Solutions; Pharmaceutical Solutions; Hyaluronic Acid; Bromides
• Other Study ID Numbers: LC2016YM017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD 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).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No