Clinical trial NCT02617459: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Primary Open-angle Glaucoma
Ocular Hypertension
Keywords: Safety
efficacy
Levobetaxolol eye drops
Chinese patients
Lead sponsor: Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.
Sponsor class: INDUSTRY
First posted: 2015-12-01
Enrollment: 366
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in intraocular pressure (IOP) from baseline at week 8 after the treatment (a.m.)
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in intraocular pressure (IOP) from baseline to week 2
timeFrame: 2 weeks
measure: Change in intraocular pressure (IOP) from baseline to week 4
timeFrame: 4 weeks
measure: Change in intraocular pressure (IOP) from baseline to week 8 (p.m.)
timeFrame: 8 weeks
measure: Change from baseline in mean visual field defect (MD) at 8 weeks after the treatment
timeFrame: 8 weeks
measure: Change in visual field pattern standard deviation (PSD) from baseline at 8 weeks after the treatment
timeFrame: 8 weeks
measure: Change in retinal nerve fiber layer (RNFL) thickness from baseline at 8 weeks after the treatment
timeFrame: 8 weeks
measure: Change in visual acuity test at week 2
timeFrame: 2 weeks
measure: Change in visual acuity test at week 4
timeFrame: 4 weeks
measure: Change in visual acuity test at week 8
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan ophthalmic center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Jian Ge, MD
role: PRINCIPAL_INVESTIGATOR
References: