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

Sponsor

Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT02617459

Collaborator

(none)

366

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

Anticipated 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 :

Nov 1, 2015

Anticipated Primary Completion Date :

Dec 1, 2020

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Decrease of intraocular pressure at week 8 [8 weeks]
Decrease of intraocular pressure at week 8

Secondary Outcome Measures

Decrease of intraocular pressure at week 2 [2 weeks]
Decrease of intraocular pressure at week 2
Decrease of intraocular pressure at week 4 [4 weeks]
Decrease of intraocular pressure at week 4
Decrease of visual field deficiency at week 8 [8 weeks]
Decrease of visual field deficiency at week 8
Decrease of nerve fiber layer thickness at week 8 [8 weeks]
Decrease of nerve fiber layer thickness at week 8
visual acuity test with Snellen chart at week 2 [2 weeks]
visual acuity test with Snellen chart at week 2
visual acuity test with Snellen chart at week 4 [8 weeks]
visual acuity test with Snellen chart at week 4
visual acuity test with Snellen chart at week 8 [8 weeks]
visual acuity test with Snellen chart at week 8

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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.