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Completed

NCT Number: NCT02617459

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

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

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Zhongshan ophthalmic center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Levobetaxolol eye drops

Drug

one drop per time; twice daily

Betaxolol eye drops

Drug

one drop per time; twice daily

Primary outcomes

  1. Change in intraocular pressure (IOP) from baseline at week 8 after the treatment (a.m.)

    Time frame: 8 weeks

    Change in intraocular pressure (IOP) from baseline at week 8 after the treatment (a.m.)

Secondary outcomes

  1. Change in intraocular pressure (IOP) from baseline to week 2

    Time frame: 2 weeks

    Change in intraocular pressure (IOP) from baseline to week 2

  2. Change in intraocular pressure (IOP) from baseline to week 4

    Time frame: 4 weeks

    Change in intraocular pressure (IOP) from baseline to week 4

  3. Change in intraocular pressure (IOP) from baseline to week 8 (p.m.)

    Time frame: 8 weeks

    Change in intraocular pressure (IOP) from baseline to week 8 (p.m.)

  4. Change from baseline in mean visual field defect (MD) at 8 weeks after the treatment

    Time frame: 8 weeks

    Change from baseline in mean visual field defect (MD) at 8 weeks after the treatment

  5. Change in visual field pattern standard deviation (PSD) from baseline at 8 weeks after the treatment

    Time frame: 8 weeks

    Change in visual field pattern standard deviation (PSD) from baseline at 8 weeks after the treatment

  6. Change in retinal nerve fiber layer (RNFL) thickness from baseline at 8 weeks after the treatment

    Time frame: 8 weeks

    Change in retinal nerve fiber layer (RNFL) thickness from baseline at 8 weeks after the treatment

  7. Change in visual acuity test at week 2

    Time frame: 2 weeks

    Change in visual acuity test at week 2

  8. Change in visual acuity test at week 4

    Time frame: 4 weeks

    Change in visual acuity test at week 4

  9. Change in visual acuity test at week 8

    Time frame: 8 weeks

    Change in visual acuity test at week 8

Sponsors and collaborators

Lead sponsor

Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Dec 1, 2015
Registry last updated
May 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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