Levobetaxolol Hydrochloride Eye Drops for Treatment of Primary Open-angle Glaucoma or Ocular Hypertension

Last updated: May 10, 2023
Sponsor: Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.
Overall Status: Completed

Phase

3

Condition

Glaucoma

Ocular Hypertension

Stress

Treatment

Levobetaxolol eye drops

Betaxolol eye drops

Clinical Study ID

NCT02617459
ZK-LBL-2016-01
  • Ages 18-70
  • All Genders

Study Summary

To evaluate the safety and efficacy of Levobetaxolol in Chinese patients with glaucoma.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Agreed to participate in this clinical trial and informed consent;
  • Aged 18 to 70 years of age, male or female;
  • In line with primary open-angle glaucoma diagnostic criteria, IOP ≥18mmHg;
  • or in compliance with ocular hypertension diagnostic criteria, intraocular pressure> 21mmHg

Exclusion

Exclusion Criteria:

  • Known or suspected to be allergic to investigational drugs and materials
  • has been diagnosed with angle-closure glaucoma, absolute glaucoma, glaucoma ciliarybody syndrome, secondary glaucoma.
  • merge various retinal lesions, such as retinal detachment, retinal vein occlusion,retinitis pigmentosa.
  • merge associated with eye infections or cornea, iris, lens obvious lesions, orone-eyed patients.
  • During the trial who must wear contact lenses, or nearly three months experts any eyesurgery or laser treatment.
  • Need systemic β-blocker therapy during the study.
  • with severe kidney disease, or abnormal liver function tests (ALT, AST≥ 1.5 times theupper limit of normal, SCr> upper limit of normal).
  • merge sinus bradycardia, over Ⅰ degree atrioventricular block, cardiogenic shock,heart failure, symptomatic hypotension or other serious heart, lung diseases (such asbronchial asthma or a history of bronchial asthma, chronic obstructive lung disease,bronchospasm, respiratory failure, etc.).
  • merge hyperthyroidism, myasthenia gravis, diabetes, advanced cancer, blood andhematopoietic system diseases, or other serious or progressive disease systems.
  • associated with neurological and psychiatric disorders
  • suspect or indeed alcohol, drug abuse history.
  • pregnancy, lactation or recent fertility planner.
  • The researchers believe other circumstances were not involved in this trial.
  • participate in other clinical trials within three months.

Study Design

Total Participants: 366
Treatment Group(s): 2
Primary Treatment: Levobetaxolol eye drops
Phase: 3
Study Start date:
January 04, 2019
Estimated Completion Date:
July 01, 2021

Study Description

To evaluate the safety and efficacy of Levobetaxolol in Chinese patients with primary open-angle glaucoma or ocular hypertension.

Connect with a study center

  • Zhongshan ophthalmic center, Sun Yat-sen University

    Guangzhou, Guangdong 510060
    China

    Site Not Available

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