Primary Open-angle GlaucomaPhase 3NCT02617459
Levobetaxolol Hydrochloride Eye Drops for Treatment of Primary Open-angle Glaucoma or Ocular Hypertension
A Phase 3 study testing Levobetaxolol eye drops and Betaxolol eye drops in people with Primary Open-angle Glaucoma and Ocular Hypertension, run by Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd. at 1 site in China.
Trial summary
To evaluate the safety and efficacy of Levobetaxolol in Chinese patients with glaucoma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Primary Open-angle Glaucoma, Ocular Hypertension
- What is being tested?
- Levobetaxolol eye drops and Betaxolol eye drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 366 participants
- Where
- 1 siteChina
- Study dates
- 4 Jan 2019to 1 Jul 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan ophthalmic center, Sun Yat-sen University
Guangzhou, Guangdong, 510060
About this study
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
To evaluate the safety and efficacy of Levobetaxolol in Chinese patients with glaucoma.
Read the detailed description
To evaluate the safety and efficacy of Levobetaxolol in Chinese patients with primary open-angle glaucoma or ocular hypertension.
- Conditions
- Primary Open-angle Glaucoma, Ocular Hypertension
- Being tested
- Levobetaxolol eye drops, Betaxolol eye drops
- Keywords
- Safety, efficacy, Levobetaxolol eye drops, Chinese patients
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levobetaxolol eye dropsDrug
one drop per time; twice daily
Betaxolol eye dropsDrug
one drop per time; twice daily
| Study group | Role | What they receive |
|---|---|---|
| Levobetaxolol eye drops | Experimental | Levobetaxolol eye drops 5ml/25mg per bottle Receives: Drug: Levobetaxolol eye drops |
| Betaxolol eye drops | Active comparator | Betaxolol eye drops 5ml/12.5mg per bottle Receives: Drug: Betaxolol eye drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: 8 weeks
Secondary outcomes (9)
Change in intraocular pressure (IOP) from baseline to week 2
Change in intraocular pressure (IOP) from baseline to week 2
Measured: 2 weeks
Change in intraocular pressure (IOP) from baseline to week 4
Change in intraocular pressure (IOP) from baseline to week 4
Measured: 4 weeks
Change in intraocular pressure (IOP) from baseline to week 8 (p.m.)
Change in intraocular pressure (IOP) from baseline to week 8 (p.m.)
Measured: 8 weeks
Change from baseline in mean visual field defect (MD) at 8 weeks after the treatment
Change from baseline in mean visual field defect (MD) at 8 weeks after the treatment
Measured: 8 weeks
Change in visual field pattern standard deviation (PSD) from baseline at 8 weeks after the treatment
Change in visual field pattern standard deviation (PSD) from baseline at 8 weeks after the treatment
Measured: 8 weeks
Change in retinal nerve fiber layer (RNFL) thickness from baseline at 8 weeks after the treatment
Change in retinal nerve fiber layer (RNFL) thickness from baseline at 8 weeks after the treatment
Measured: 8 weeks
Change in visual acuity test at week 2
Change in visual acuity test at week 2
Measured: 2 weeks
Change in visual acuity test at week 4
Change in visual acuity test at week 4
Measured: 4 weeks
Change in visual acuity test at week 8
Change in visual acuity test at week 8
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2015 (estimated)
- Study start4 Jan 2019
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Open-angle GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 366 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jian Ge, MD, Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02617459
- Sponsor's protocol ID
- ZK-LBL-2016-01
- Status last verified
- May 2023
- First submitted
- 18 Nov 2015
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02617459
- Acronym / sponsor ID
- ZK-LBL-2016-01
- Conditions
- Primary Open-angle Glaucoma, Ocular Hypertension
- Keywords
- Safety, efficacy, Levobetaxolol eye drops, Chinese patients
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 366 participants (actual)
- Lead sponsor
- Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Jan 2019 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 1 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levobetaxolol eye drops | Experimental | Drug: Levobetaxolol eye dropsLevobetaxolol eye drops 5ml/25mg per bottle |
| Betaxolol eye drops | Active comparator | Drug: Betaxolol eye dropsBetaxolol eye drops 5ml/12.5mg per bottle |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levobetaxolol eye dropsone drop per time; twice daily | Drug | Levobetaxolol eye drops |
| Betaxolol eye dropsone drop per time; twice daily | Drug | Betaxolol eye drops |
Primary outcome
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.)
9 secondary outcomes
Change in intraocular pressure (IOP) from baseline to week 2
Time frame: 2 weeks
Change in intraocular pressure (IOP) from baseline to week 4
Time frame: 4 weeks
Change in intraocular pressure (IOP) from baseline to week 8 (p.m.)
Time frame: 8 weeks
Change from baseline in mean visual field defect (MD) 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
Time frame: 8 weeks
Change in retinal nerve fiber layer (RNFL) thickness from baseline at 8 weeks after the treatment
Time frame: 8 weeks
Change in visual acuity test at week 2
Time frame: 2 weeks
Change in visual acuity test at week 4
Time frame: 4 weeks
Change in visual acuity test at week 8
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jian Ge, MD principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Levobetaxolol eye drops and Betaxolol eye drops in people with Primary Open-angle Glaucoma and Ocular Hypertension, run by Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in intraocular pressure (IOP) from baseline at week 8 after the treatment (a.m.) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2023.