GlaucomaPhase 4NCT00972426
A Study to Evaluate Efficacy and Safety Effects Using Mikelan® LA Ophthalmic Solution (OS) 2% Versus Timoptol® XE Ophthalmic Solution (OS) 0.5% in Ocular Hypertension Patients
A Phase 4 study testing carteolol (Mikelan), timolol (Timoptol), latanoprost (Xalatan) in people with Glaucoma, run by Taiwan Otsuka Pharm. Co., Ltd at 1 site in Taiwan.
Trial summary
The primary objective of the clinical study is to evaluate the efficacy and safety for Mikelan LA eye drops 2% (once per day) of intra-ocular pressure decreased. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Glaucoma
- What is being tested?
- carteolol (Mikelan), timolol (Timoptol), latanoprost (Xalatan)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2009to Aug 2010
- Phase
- Phase 4
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or females outpatients with primary open-angle glaucoma or ocular hypertension;
- Subjects who have received Latanoprost at least 4 weeks, and in the end of screening period, subject's Intra-Ocular Pressure is ≧18mmHg (choice of one eyes is possible), or Investigator judges the reduction of IOP is insufficient of individual subject.
- Aged between ≧ 20 and ≦80 years old when giving informed consent to the study.
Who cannot join
- Hypersensitivity to either oral or topical beta-blocker therapy or to any ophthalmic solution used in the study;
- Patients wearing contact lenses;
- Patients with severe dry eyes;
- Patients who had ophthalmic surgery including cataract surgery, trabeculotomy or trabeculectomy within three months of study start;
- Patients who had laser trabeculoplasty within 2 months before starting study;
- Patients who had corneal contamination, and acute ophthalmic infection, or inflammatory ophthalmic disorder 2 months before starting study;
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- Patients who had herpetic keratitis or corneal ulcer within 2 months before starting study;
- Patient who are receiving systemic administration of drugs that may have and effect on IOP;
- Patients who have poorly controlled heart failure, sinus bradycardia, atrioventricular block (1 and 2 grade), or cardiogenic shock;
- Patients with brochial asthma, bronchospasm or severe chronic obstructive pulmonary disease or a history thereof;
- Patients with poorly controlled diabetes or diabetic ketoacidosis or metabolic acidosis;
- Patients with aortic stenosis, Raynaud's syndrome, intermittent claudication, or pheochromocytoma;
- Patients with myasthenia gravis;
- Patients with severe hepatic or renal disorder judged by investigator;
- Patients who have confirmed or potential pregnancy, current lactation, or wish to become pregnant during the study period;
- Patients who have treatment with any investigational drug when giving informed consent;
- Patients with significant alcohol, drug or medication abuse as judged by investigator;
- Patients whom investigator judges as subjects to be inappropriate for the clinical study (e.g., patient with severe complication)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Parallel, Open-label Study to Evaluate Efficacy and Safety Effects Using Mikelan® LA Ophthalmic Solution (OS) 2% Versus Timoptol® XE Ophthalmic Solution (OS) 0.5% in Ocular Hypertension Patients
The primary objective of the clinical study is to evaluate the efficacy and safety for Mikelan LA eye drops 2% (once per day) of intra-ocular pressure decreased.
- Conditions
- Glaucoma
- Being tested
- carteolol (Mikelan), timolol (Timoptol), latanoprost (Xalatan)
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carteolol (Mikelan), timolol (Timoptol), latanoprost (Xalatan)Drug
Experimental: Mikelan, 1 drop/daily, for 8 weeks Active Comparator: Timoptol, 1 drop/daily, for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Treatment A Group | Experimental | Mikelan LA + Xalatan Receives: Drug: carteolol (Mikelan), timolol (Timoptol), latanoprost (Xalatan) |
| Treatment B Group | Active comparator | Timoptol XE + Xalatan Receives: Drug: carteolol (Mikelan), timolol (Timoptol), latanoprost (Xalatan) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change value of Intra-Ocular Pressure (IOP) in study group
Measured: assessment will be done every month for 2 months for each subject
Secondary outcomes (3)
The change value of IOP between groups
Measured: assessment will be done every month for 2 months for each subject
The change percentage of IOP in each group
Measured: assessment will be done every month for 2 months for each subject
The change of score of Patient satisfaction in each group
Measured: assessment will be done every month for 2 months for each subject
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2009 (estimated)
- Study startOct 2009
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taiwan Otsuka Pharm. Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Da-Wen Lu, MD/PhD, Principal investigator, Department of Opthalmology/ Tri-Service General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00972426
- Sponsor's protocol ID
- 001-TWB-0901(n)
- Status last verified
- Sep 2011
- First submitted
- 20 Aug 2009
- Last updated
- 5 Sep 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Parallel, Open-label Study to Evaluate Efficacy and Safety Effects Using Mikelan® LA Ophthalmic Solution (OS) 2% Versus Timoptol® XE Ophthalmic Solution (OS) 0.5% in Ocular Hypertension Patients
- ClinicalTrials.gov ID
- NCT00972426
- Acronym / sponsor ID
- 001-TWB-0901(n)
- Conditions
- Glaucoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Taiwan Otsuka Pharm. Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 7 Sep 2009 (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.
The primary objective of the clinical study is to evaluate the efficacy and safety for Mikelan LA eye drops 2% (once per day) of intra-ocular pressure decreased.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment A Group | Experimental | Drug: carteolol (Mikelan), timolol (Timoptol), latanoprost (Xalatan)Mikelan LA + Xalatan |
| Treatment B Group | Active comparator | Drug: carteolol (Mikelan), timolol (Timoptol), latanoprost (Xalatan)Timoptol XE + Xalatan |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or females outpatients with primary open-angle glaucoma or ocular hypertension;
- Subjects who have received Latanoprost at least 4 weeks, and in the end of screening period, subject's Intra-Ocular Pressure is ≧18mmHg (choice of one eyes is possible), or Investigator judges the reduction of IOP is insufficient of individual subject.
- Aged between ≧ 20 and ≦80 years old when giving informed consent to the study.
Key exclusion criteria (18 listed)
- Hypersensitivity to either oral or topical beta-blocker therapy or to any ophthalmic solution used in the study;
- Patients wearing contact lenses;
- Patients with severe dry eyes;
- Patients who had ophthalmic surgery including cataract surgery, trabeculotomy or trabeculectomy within three months of study start;
- Patients who had laser trabeculoplasty within 2 months before starting study;
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 |
|---|---|---|
| carteolol (Mikelan), timolol (Timoptol), latanoprost (Xalatan)Experimental: Mikelan, 1 drop/daily, for 8 weeks Active Comparator: Timoptol, 1 drop/daily, for 8 weeks | Drug | Treatment A Group, Treatment B Group |
Primary outcome
The change value of Intra-Ocular Pressure (IOP) in study group
Time frame: assessment will be done every month for 2 months for each subject
3 secondary outcomes
The change value of IOP between groups
Time frame: assessment will be done every month for 2 months for each subject
The change percentage of IOP in each group
Time frame: assessment will be done every month for 2 months for each subject
The change of score of Patient satisfaction in each group
Time frame: assessment will be done every month for 2 months for each subject
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 5 Sep 2011.
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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.
Da-Wen Lu, MD/PhD principal investigator
Department of Opthalmology/ Tri-Service General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing carteolol (Mikelan), timolol (Timoptol), latanoprost (Xalatan) in people with Glaucoma, run by Taiwan Otsuka Pharm. Co., Ltd at 1 site in Taiwan.
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 3 inclusion and 18 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 5 Sep 2011. 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 Taiwan. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The change value of Intra-Ocular Pressure (IOP) in study group (time frame: assessment will be done every month for 2 months for each subject). 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 5 Sep 2011.