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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02617459
Recruitment Status : Unknown
Verified January 2020 by Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd..
Recruitment status was:  Recruiting
First Posted : December 1, 2015
Last Update Posted : May 8, 2020
Sponsor:
Information provided by (Responsible Party):
Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.

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

Condition or disease Intervention/treatment Phase
Primary Open-angle Glaucoma Ocular Hypertension Drug: Levobetaxolol eye drops Drug: Betaxolol eye drops Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 366 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Open-label, Positive-controlled, Parallel-group Clinical Trial of Levobetaxolol Hydrochloride Eye Drops in Patients With Primary Open-angle Glaucoma or Ocular Hypertension
Study Start Date : November 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Betaxolol

Arm Intervention/treatment
Experimental: Levobetaxolol eye drops
Levobetaxolol eye drops 5ml/25mg per bottle
Drug: Levobetaxolol eye drops
one drop per time; twice daily

Active Comparator: Betaxolol eye drops
Betaxolol eye drops 5ml/12.5mg per bottle
Drug: Betaxolol eye drops
one drop per time; twice daily




Primary Outcome Measures :
  1. Decrease of intraocular pressure at week 8 [ Time Frame: 8 weeks ]
    Decrease of intraocular pressure at week 8


Secondary Outcome Measures :
  1. Decrease of intraocular pressure at week 2 [ Time Frame: 2 weeks ]
    Decrease of intraocular pressure at week 2

  2. Decrease of intraocular pressure at week 4 [ Time Frame: 4 weeks ]
    Decrease of intraocular pressure at week 4

  3. Decrease of visual field deficiency at week 8 [ Time Frame: 8 weeks ]
    Decrease of visual field deficiency at week 8

  4. Decrease of nerve fiber layer thickness at week 8 [ Time Frame: 8 weeks ]
    Decrease of nerve fiber layer thickness at week 8

  5. visual acuity test with Snellen chart at week 2 [ Time Frame: 2 weeks ]
    visual acuity test with Snellen chart at week 2

  6. visual acuity test with Snellen chart at week 4 [ Time Frame: 8 weeks ]
    visual acuity test with Snellen chart at week 4

  7. visual acuity test with Snellen chart at week 8 [ Time Frame: 8 weeks ]
    visual acuity test with Snellen chart at week 8



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 Criteria:

  • Known or suspected to be allergic to investigational drugs and materials
  • has been diagnosed with angle-closure glaucoma, absolute glaucoma, glaucoma ciliary body 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, or one-eyed patients.
  • During the trial who must wear contact lenses, or nearly three months experts any eye surgery 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 the upper 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 as bronchial asthma or a history of bronchial asthma, chronic obstructive lung disease, bronchospasm, respiratory failure, etc.).
  • merge hyperthyroidism, myasthenia gravis, diabetes, advanced cancer, blood and hematopoietic 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02617459


Contacts
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Contact: Jian Ge, MD +86-20-87330000

Locations
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China, Guangdong
Zhongshan ophthalmic center, Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Jian Ge, MD    0+86-20-87330000      
Principal Investigator: Jian Ge, MD         
Sponsors and Collaborators
Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.
Investigators
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Principal Investigator: Jian Ge, MD Zhongshan Ophthalmic Center, Sun Yat-sen University
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Responsible Party: Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.
ClinicalTrials.gov Identifier: NCT02617459    
Other Study ID Numbers: Zhaoke-201506-Levobetaxolol
First Posted: December 1, 2015    Key Record Dates
Last Update Posted: May 8, 2020
Last Verified: January 2020
Keywords provided by Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.:
Safety
efficacy
Levobetaxolol eye drops
Chinese patients
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Betaxolol
Ophthalmic Solutions
Pharmaceutical Solutions
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action