GlaucomaPhase 4NCT00442312
Combigan Ophthalmic Solution(Brimonidine 0.2% and Timolol 0.5%)With Latanoprost Compared With Latanoprost Monotherapy
A Phase 4 study testing Combigan Ophthalmic Solutiom in people with Glaucoma, run by Genovate Biotechnology Co., Ltd., at 1 site in Taiwan.
Trial summary
This study is to evaluate the efficacy and safety of Combigan ophthalmic solution in combination with Latanoprost when the therapy is swiched from Latanoprost monotherapy in patient with Glaucoma or ocular hypertension. Hypothesis: 1. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Combigan Ophthalmic Solutiom
- How many people
- 43 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2006to Nov 2006
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, of legal age of consent.
- Diagnosis of ocular hypertension (OHT) or glaucoma (incl. open angle glaucoma, chronic angle closure glaucoma, exfoliative glaucoma, pigmentary glaucoma or pseudophakic glaucoma) and requiring administration of IOP lowering eye drops.
- Written informed consent has been obtained.
- The patient can understand all study instructions, and is willing and able to comply with the schedule of visits and treatment.
- Patient has been administering latanoprost eye drops as monotherapy in affected eye(s) for at least 12 weeks according to the approved product labeling.
- Patient's Day 0 IOP > 18 mm Hg in the proposed study eye/s on established latanoprost therapy.
- Patients who have used COMBIGAN® Ophthalmic Solution in the past must not have been discontinued from using this medication due to adverse events or due to lack of efficacy.
- Day 0: negative urine pregnancy test for females of childbearing potential.
Who cannot join
- .Uncontrolled systemic disease (e.g., hypertension, diabetes).
- .Females who are pregnant, nursing, or planning a pregnancy, or females of childbearing potential who are not using a reliable means of contraception. A female is considered of child-bearing potential unless she is post-menopausal, without a uterus and/or both ovaries, or has a tubal-ligation.
- .Known allergy or hypersensitivity to the study medication or components.
- .Anticipated alteration of existing chronic therapy with agents which could have a substantial effect on IOP (including, but not necessarily limited to systemic adrenergic agents including beta-adrenergic blocking agents [e.g., propanolol, metoprolol, nadolol, timolol and atenolol]), substantial interaction with study medications, or interaction with study outcomes.
- .Corneal abnormalities that would preclude accurate IOP readings with an applanation tonometer.
- .Any other active ocular disease other than glaucoma or ocular hypertension (e.g., uveitis, ocular infections, or severe dry eye). However, patients with chronic mild blepharitis, cataract, age-related macular degeneration, or a background diabetic retinopathy can be enrolled at the discretion of the investigator.
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- .Required chronic use of other ocular medications during the study other than the study medications. Occasional use of artificial tears or topical decongestants and/or antihistamine is acceptable. Use of these within 24 hours of a scheduled study visit is prohibited.
- .Ocular surgery within the past 3 months.
- .Current enrolment in an investigational drug or device study or participation in such a study within 30 days of entry into this study.
- .Patient has a condition or is in a situation which in the investigator's opinion may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study,
- .Day 0 - Significant ocular irritation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label,Switch Study of the Safety and Efficacy of Combigan Ophthalmic Solution(Brimonidine 0.2% and Timolol 0.5%)With Latanoprost Compared With Latanoprost Monotherapy in Patient With Glaucoma or Ocular Hypertension.
This study is to evaluate the efficacy and safety of Combigan ophthalmic solution in combination with Latanoprost when the therapy is swiched from Latanoprost monotherapy in patient with Glaucoma or ocular hypertension.
Hypothesis:
- Combigan Ophthalmic Solution provides addition IOP loweringwhen combined with Latanoprost.
- The treatment with Combigan Ophthalmic Solution has an acceptable safety profile, as measured by ocular and systemic safety parameters.
Read the detailed description
The purpose of this study is to comparethe efficacy and safety Ophthalmic Solution in combination with Latanoprost when the therapy is swiched from Latanoprost monotherapy in patient with Glaucoma or ocular hypertension.
The study will be open label, prospective, multi-centered where patients will be swiched from Latanoprostmonotherapy to a combination therapy of Latanoprost with Combigan Ophthalmic Solution.
- Conditions
- Glaucoma
- Being tested
- Combigan Ophthalmic Solutiom
- Keywords
- Combigan
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combigan Ophthalmic SolutiomDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of IntraOcular Pressure From baseline to week 12
Secondary outcomes (2)
The change of IntraOcular Pressure on week 8.
The change of IntraOcular Pressure on week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2007 (estimated)
- Study startMay 2006
- Study completionNov 2006
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
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants
Sponsor and investigators
- Lead sponsor
- Genovate Biotechnology Co., Ltd.,
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Allergan Medical
- Investigators
- Da-Wen Lu, Principal investigator, Tri-Service General Hospital, Taiwan ROC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00442312
- Sponsor's protocol ID
- COM 003
- Status last verified
- Feb 2007
- First submitted
- 27 Feb 2007
- Last updated
- 1 Mar 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label,Switch Study of the Safety and Efficacy of Combigan Ophthalmic Solution(Brimonidine 0.2% and Timolol 0.5%)With Latanoprost Compared With Latanoprost Monotherapy in Patient With Glaucoma or Ocular Hypertension.
- ClinicalTrials.gov ID
- NCT00442312
- Acronym / sponsor ID
- COM 003
- Conditions
- Glaucoma
- Keywords
- Combigan
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 43 participants
- Lead sponsor
- Genovate Biotechnology Co., Ltd.,Industry (pharma, biotech, devices)
- Collaborators
- Allergan Medical
- Study start
- May 2006
- Study completion
- Nov 2006
- First posted
- 1 Mar 2007 (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.
This study is to evaluate the efficacy and safety of Combigan ophthalmic solution in combination with Latanoprost when the therapy is swiched from Latanoprost monotherapy in patient with Glaucoma or ocular hypertension.
Hypothesis:
- Combigan Ophthalmic Solution provides addition IOP loweringwhen combined with Latanoprost.
- The treatment with Combigan Ophthalmic Solution has an acceptable safety profile, as measured by ocular and systemic safety parameters.
Detailed description
The purpose of this study is to comparethe efficacy and safety Ophthalmic Solution in combination with Latanoprost when the therapy is swiched from Latanoprost monotherapy in patient with Glaucoma or ocular hypertension.
The study will be open label, prospective, multi-centered where patients will be swiched from Latanoprostmonotherapy to a combination therapy of Latanoprost with Combigan Ophthalmic Solution.
Study design
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female, of legal age of consent.
- Diagnosis of ocular hypertension (OHT) or glaucoma (incl. open angle glaucoma, chronic angle closure glaucoma, exfoliative glaucoma, pigmentary glaucoma or pseudophakic glaucoma) and requiring administration of IOP lowering eye drops.
- Written informed consent has been obtained.
- The patient can understand all study instructions, and is willing and able to comply with the schedule of visits and treatment.
- Patient has been administering latanoprost eye drops as monotherapy in affected eye(s) for at least 12 weeks according to the approved product labeling.
Key exclusion criteria (11 listed)
- .Uncontrolled systemic disease (e.g., hypertension, diabetes).
- .Females who are pregnant, nursing, or planning a pregnancy, or females of childbearing potential who are not using a reliable means of contraception. A female is considered of child-bearing potential unless she is post-menopausal, without a uterus and/or both ovaries, or has a tubal-ligation.
- .Known allergy or hypersensitivity to the study medication or components.
- .Anticipated alteration of existing chronic therapy with agents which could have a substantial effect on IOP (including, but not necessarily limited to systemic adrenergic agents including beta-adrenergic blocking agents [e.g., propanolol, metoprolol, nadolol, timolol and atenolol]), substantial interaction with study medications, or interaction with study outcomes.
- .Corneal abnormalities that would preclude accurate IOP readings with an applanation tonometer.
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 |
|---|---|---|
| Combigan Ophthalmic Solutiom | Drug | – |
Primary outcome
The change of IntraOcular Pressure From baseline to week 12
2 secondary outcomes
The change of IntraOcular Pressure on week 8.
The change of IntraOcular Pressure on week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2007.
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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 principal investigator
Tri-Service General Hospital, Taiwan ROC
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 Combigan Ophthalmic Solutiom in people with Glaucoma, run by Genovate Biotechnology 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 8 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 1 Mar 2007. 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?
Results are not available in the source record.
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 of IntraOcular Pressure From baseline to week 12. 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 1 Mar 2007.