NCT02617459

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
366

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 1, 2015

Completed
3.1 years until next milestone

Study Start

First participant enrolled

January 4, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

May 12, 2023

Status Verified

May 1, 2023

Enrollment Period

2.5 years

First QC Date

November 18, 2015

Last Update Submit

May 10, 2023

Conditions

Primary Open-angle GlaucomaOcular Hypertension

Keywords

SafetyefficacyLevobetaxolol eye dropsChinese patients

Outcome Measures

Primary Outcomes (1)

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

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

    8 weeks

Secondary Outcomes (9)

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

    2 weeks

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

    4 weeks

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

    8 weeks

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

    8 weeks

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

    8 weeks

  • +4 more secondary outcomes

Study Arms (2)

Levobetaxolol eye drops

EXPERIMENTAL

Levobetaxolol eye drops 5ml/25mg per bottle

Drug: Levobetaxolol eye drops

Betaxolol eye drops

ACTIVE COMPARATOR

Betaxolol eye drops 5ml/12.5mg per bottle

Drug: Betaxolol eye drops

Interventions

Levobetaxolol eye dropsDRUG

one drop per time; twice daily

Levobetaxolol eye drops
Betaxolol eye dropsDRUG

one drop per time; twice daily

Betaxolol eye drops

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan ophthalmic center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Glaucoma, Open-AngleOcular Hypertension

Condition Hierarchy (Ancestors)

GlaucomaEye Diseases

Study Officials

  • Jian Ge, MD

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2015

First Posted

December 1, 2015

Study Start

January 4, 2019

Primary Completion

July 1, 2021

Study Completion

July 1, 2021

Last Updated

May 12, 2023

Record last verified: 2023-05

Locations

CN(1)