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

Last updated: April 22, 2018
Sponsor: Shenzhen Hospital of Southern Medical University
Overall Status: Active - Not Recruiting

Phase

3

Condition

Sjogren's Syndrome

Glaucoma

Dry Eyes

Treatment

N/A

Clinical Study ID

NCT03515187
LC2016YM017
  • Ages 18-80
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18-80 years of age, diagnosed with glaucoma, including primary open-angle glaucoma orprimary angle closure glaucoma, require treatment with anti-glaucoma eye drops.

  • A group: Patients using glaucoma eye drops longer than 6 months, and in accordancewith the diagnostic criteria of dry eye:

  1. Subjective symptoms (required): dryness, foreign body sensation, fatigue anddiscomfort;

  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); inthe 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 intraocularpressure, and if the basal intraocular pressure is the same, choose the right eye forthe study.

  • Voluntary participation in this clinical study, and signed informed consent.

Exclusion

Exclusion Criteria:

  • With metabolic diseases, autoimmune diseases, connective tissue diseases, such asdiabetes, 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 twoweeks.

  • With drug therapy, embolization and surgical treatment of dry eyes.

  • With other eye diseases, such as eyelid defects, hypophasis, pterygium, chronicdacryocystitis, trichiasis, corneal lesions.

Study Design

Total Participants: 160
Study Start date:
June 01, 2018
Estimated Completion Date:
October 31, 2021

Study 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.

Connect with a study center

  • Yingli Li

    Shenzhen, Guangdong 518110
    China

    Site Not Available

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