Ocular HypertensionNCT01084902
Efficacy Comparison of Xalatan and Azopt on POAG and OH
A study testing Latanoprost and Brinzolamide in people with Ocular Hypertension, run by Peking University First Hospital.
Trial summary
Prostaglandin analogs (PGAs) represent a new class of active ocular hypotensive agents and possess a unique mechanism of action. Many studies suggested that 0.005% Latanoprost was more effective and safer than other anti-glaucoma medications, such as beta-blockers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ocular Hypertension
- What is being tested?
- Latanoprost and Brinzolamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- Feb 2010to Dec 2010
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with POAG or OHT
- Older than 18 years, either sex
- With IOP≤30mmHg in both eyes and with IOP>21mmHg in either eye after washout
- Understand the study instructions and are willing to attend at all follow-up appointments
- Be willing to comply with study medication use
- Ready for written informed consent
Who cannot join
- Visual field defects within the central 10°
- Absence of vision in one eye
- History of hypersensitivity to any components of the study medications
- Contraindications to carbonic anhydrase inhibitors or prostaglandins
- History of ocular herpetic disease, uveitis, or cystoid macular edema
- Ocular history of trauma, inflammation, surgery or use of corticosteroids (within 2 months)
Show all 12Show fewer
- History of ocular laser therapy within 3 months
- Severe dry eyes
- Signs of ocular infection, except blepharitis
- Corneal abnormality that may affect IOP measurements
- Unwilling to accept the risk for hyperchromia of the iris or development of hypertrichosis
- Pregnant females or lactating mothers
About this study
Official title: Comparison of the Effects of Latanoprost(0.005%) and Brinzolamide(1.0%) on Intraocular Pressure in Primary Open-angle Glaucoma and Ocular Hypertension
Prostaglandin analogs (PGAs) represent a new class of active ocular hypotensive agents and possess a unique mechanism of action. Many studies suggested that 0.005% Latanoprost was more effective and safer than other anti-glaucoma medications, such as beta-blockers. It has also been found to be more effective than other class of anti-glaucoma medications such as carbonic anhydrase inhibitors and alpha agonists. However data on such comparison is lacking in Chinese patients. So it is necessary to increase China experience and get clinical data from China. Besides latanoprost, brinzolamide is known as one of the other ocular hypotensive agents with less systemic adverse effects, therefore it is selected as the controlled medication of this study. The administration phase will be 4 weeks because it is long enough to compare both efficacy and safety of the study drugs and accounting for following-up conditions in China, it will be easier for the investigators to get enough subjects in a limited stage if the observation time is shorter.
Before treatment with the study drugs, any previous glaucoma drugs will be washed out. The minimum washout periods are 5 days for cholinergic agonists, 1 week for adrenergic agonists, 3 weeks for adrenergic β receptor blockers and 4 weeks for PGAS. After washout, the patients will be randomised send to two parallel study groups: one group will receive latanoprost 0.005% once daily in the evening, the other group receive 1.0% Brinzolamide twice daily. Randomization will be obtained using a list of random numbers .During the study there will be four visits: screening, baseline, 2 weeks, and 4 weeks of treatment. The IOP will be measured with a Goldmann tonometer at 8 am for each visit. The tonometry will be performed before the administration of the dose of the day in patients treated with Brinzolamide. Three separate measurements will be taken for each eye and the mean of the three measurements will be used in the statistical analysis. Best corrected visual acuity and refraction will be determined and a slit lamp examination, ophthalmoscopy will be performed at all visits.
- Conditions
- Ocular Hypertension
- Being tested
- Latanoprost, Brinzolamide
- Keywords
- POAG, OH, Xalatan, Azopt, Primary Open Angle Study
- Medical subject headings
- Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LatanoprostDrug
once daily
BrinzolamideDrug
Two times daily
| Study group | Role | What they receive |
|---|---|---|
| latnoprost | Experimental | once daily Receives: Drug: Latanoprost |
| Brinzolamide | Active comparator | two times daily Receives: Drug: Brinzolamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular Pressure
Three separate measurements will be taken for each eye. And mean result will be taken if the difference between measurements is within 2 mmHg , or use the median if the difference between measurements is greater than 3 mmHg.
Measured: Baseline, 2 weeks, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2010 (estimated)
- Study startFeb 2010
- Primary completionSep 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular HypertensionStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Yingzi Pan, doctor, Study chair, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01084902
- Sponsor's protocol ID
- PKU1H001
- Other IDs
- PKU1H
- Status last verified
- Mar 2010
- First submitted
- 10 Mar 2010
- Last updated
- 11 Mar 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Latanoprost(0.005%) and Brinzolamide(1.0%) on Intraocular Pressure in Primary Open-angle Glaucoma and Ocular Hypertension
- ClinicalTrials.gov ID
- NCT01084902
- Acronym / sponsor ID
- PKU1H001
- Conditions
- Ocular Hypertension
- Keywords
- POAG, OH, Xalatan, Azopt, Primary Open Angle Study
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Sep 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 11 Mar 2010 (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.
Prostaglandin analogs (PGAs) represent a new class of active ocular hypotensive agents and possess a unique mechanism of action. Many studies suggested that 0.005% Latanoprost was more effective and safer than other anti-glaucoma medications, such as beta-blockers. It has also been found to be more effective than other class of anti-glaucoma medications such as carbonic anhydrase inhibitors and alpha agonists. However data on such comparison is lacking in Chinese patients. So it is necessary to increase China experience and get clinical data from China. Besides latanoprost, brinzolamide is known as one of the other ocular hypotensive agents with less systemic adverse effects, therefore it is selected as the controlled medication of this study. The administration phase will be 4 weeks because it is long enough to compare both efficacy and safety of the study drugs and accounting for following-up conditions in China, it will be easier for the investigators to get enough subjects in a limited stage if the observation time is shorter.
Before treatment with the study drugs, any previous glaucoma drugs will be washed out. The minimum washout periods are 5 days for cholinergic agonists, 1 week for adrenergic agonists, 3 weeks for adrenergic β receptor blockers and 4 weeks for PGAS. After washout, the patients will be randomised send to two parallel study groups: one group will receive latanoprost 0.005% once daily in the evening, the other group receive 1.0% Brinzolamide twice daily. Randomization will be obtained using a list of random numbers .During the study there will be four visits: screening, baseline, 2 weeks, and 4 weeks of treatment. The IOP will be measured with a Goldmann tonometer at 8 am for each visit. The tonometry will be performed before the administration of the dose of the day in patients treated with Brinzolamide. Three separate measurements will be taken for each eye and the mean of the three measurements will be used in the statistical analysis. Best corrected visual acuity and refraction will be determined and a slit lamp examination, ophthalmoscopy will be performed at all visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| latnoprost | Experimental | Drug: Latanoprostonce daily |
| Brinzolamide | Active comparator | Drug: Brinzolamidetwo times daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosed with POAG or OHT
- Older than 18 years, either sex
- With IOP≤30mmHg in both eyes and with IOP>21mmHg in either eye after washout
- Understand the study instructions and are willing to attend at all follow-up appointments
- Be willing to comply with study medication use
Key exclusion criteria (12 listed)
- Visual field defects within the central 10°
- Absence of vision in one eye
- History of hypersensitivity to any components of the study medications
- Contraindications to carbonic anhydrase inhibitors or prostaglandins
- History of ocular herpetic disease, uveitis, or cystoid macular edema
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 |
|---|---|---|
| Latanoprostonce daily | Drug | latnoprost |
| BrinzolamideTwo times daily | Drug | Brinzolamide |
Primary outcome
Intraocular Pressure
Time frame: Baseline, 2 weeks, 4 weeks
Three separate measurements will be taken for each eye. And mean result will be taken if the difference between measurements is within 2 mmHg , or use the median if the difference between measurements is greater than 3 mmHg.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2010.
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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.
Yingzi Pan, doctor study chair
Peking University First Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Latanoprost and Brinzolamide in people with Ocular Hypertension, run by Peking University First Hospital.
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 6 inclusion and 12 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 11 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Intraocular Pressure (time frame: Baseline, 2 weeks, 4 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 11 Mar 2010.