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

Primary Purpose

Primary Open-angle Glaucoma, Ocular Hypertension

Status

Completed

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Levobetaxolol eye drops

Betaxolol eye drops

About this trial

This is an interventional treatment trial for Primary Open-angle Glaucoma focused on measuring Safety, efficacy, Levobetaxolol eye drops, Chinese patients

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Zhongshan ophthalmic center, Sun Yat-sen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Levobetaxolol eye drops

Betaxolol eye drops

Arm Description

Levobetaxolol eye drops 5ml/25mg per bottle

Betaxolol eye drops 5ml/12.5mg per bottle

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

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

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

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

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

Change in visual acuity test at week 2

Change in visual acuity test at week 4

Change in visual acuity test at week 8

Full Information

NCT ID

NCT02617459

First Posted

November 18, 2015

Last Updated

May 10, 2023

Sponsor

Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02617459

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Completed

Study Start Date

January 4, 2019 (Actual)

Primary Completion Date

July 1, 2021 (Actual)

Study Completion Date

July 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Open-angle Glaucoma, Ocular Hypertension

Keywords

Safety, efficacy, Levobetaxolol eye drops, Chinese patients

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

366 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Levobetaxolol eye drops

Arm Type

Experimental

Arm Description

Levobetaxolol eye drops 5ml/25mg per bottle

Arm Title

Betaxolol eye drops

Arm Type

Active Comparator

Arm Description

Betaxolol eye drops 5ml/12.5mg per bottle

Intervention Type

Drug

Intervention Name(s)

Levobetaxolol eye drops

Intervention Description

one drop per time; twice daily

Intervention Type

Drug

Intervention Name(s)

Betaxolol eye drops

Intervention Description

one drop per time; twice daily

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

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

Description

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

Time Frame

2 weeks

Title

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

Description

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

Time Frame

4 weeks

Title

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

Description

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

Time Frame

8 weeks

Title

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

Description

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

Time Frame

8 weeks

Title

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

Description

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

Time Frame

8 weeks

Title

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

Description

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

Time Frame

8 weeks

Title

Change in visual acuity test at week 2

Description

Change in visual acuity test at week 2

Time Frame

2 weeks

Title

Change in visual acuity test at week 4

Description

Change in visual acuity test at week 4

Time Frame

4 weeks

Title

Change in visual acuity test at week 8

Description

Change in visual acuity test at week 8

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jian Ge, MD

Organizational Affiliation

Zhongshan Ophthalmic Center, Sun Yat-sen University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Zhongshan ophthalmic center, Sun Yat-sen University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

12. IPD Sharing Statement

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

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