Open Angle GlaucomaPhase 3NCT01721707
Latanoprost/Brinzolamide BID Versus Latanoprost BID in Patients With OAG or OH
A Phase 3 study testing Latanoprost+Brinzolamide combination and Latanoprost in people with Open Angle Glaucoma and Ocular Hypertension, run by Adapt Produtos Oftalmológicos Ltda. at 1 site in Brazil.
Trial summary
This study is a double-masked, randomized, parallel group study in patients with open angle glaucoma or ocular hypertension. The aim of this study is to verify the efficacy of the fixed combination of Latanoprost 50 mcg / mL / brinzolamide 10mg/ml eye drops compared to Latanoprost 50μg/mL eye drops in reducing IOP Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open Angle Glaucoma, Ocular Hypertension
- What is being tested?
- Latanoprost+Brinzolamide combination and Latanoprost
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2012to Jun 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 years of age or older, of either gender and of any race / ethnicity, diagnosed with open angle glaucoma or ocular hypertension, which in the opinion of the investigator does not have enough control with monotherapy or already receiving multiple medications for lowering IOP .
- Patients should be able to understand and sign an informed consent form that has been approved by an Institutional Review Board.
- Measurements of mean IOP in at least 1 eye:
- ≥ 24 mmHg and ≤ 36 mmHg at timepoint 9am and
- ≥ 21 mmHg and ≤ 36 mmHg in the 11h timepoint in both Visits Eligibility 1 and after washout of any medication to reduce IOP.
- The mean IOP should not be> 36 mmHg at any timepoint
Who cannot join
- Fertile women (those not surgically sterile or postmenopausal for at least 1 year) are excluded from study participation if meet any of the following conditions:
- currently pregnant or
- have tested positive in urine pregnancy Screening Visit or
- planning to become pregnant during the study period, or
- are breastfeeding, or not using highly effective contraceptive precautions.
- Patients with angle Schaffer Grade <2, as measured by gonioscopy (extreme narrow angle with complete or partial closure).
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- Patients with a ratio cup / disc greater than 0.80 (horizontal or vertical).
- Patients presenting with loss of central visual field impairment. The loss of central visual field is defined as a serious sensitivity less than or equal to 10 dB in at least four points of two visual field test closest to the point of attachment.
- Patients who can not safely discontinue use of all medications to ocular IOP reduction for a minimum of 5 days ± 1 day to 28 days ± 1 day prior to Visit E1.
- Chronic inflammatory eye disease, recurrent or severe (ie, scleritis, uveitis, herpetic keratitis).
- Ocular trauma in the past 6 months.
- Eye infection or inflammation of the eye in the last 3 months.
- Retinal disease as clinically significant or progressive retinal degeneration, diabetic retinopathy or retinal detachment.
- Best score corrected visual acuity (BCVA) worse than 55 ETDRS letters (equivalent to approximately 20/80 Snellen).
- Another ocular pathology (including severe dry eye) that may, in the opinion of the investigator, preventing the administration of an alpha-adrenergic agonist and/or an inhibitor of topical carbonic anhydrase (CAI).
- Intraocular surgery within the last 6 months.
- Laser eye surgery in the last 3 months.
- Any abnormality that prevents a reliable applanation tonometry.
- Any other condition including severe illness that would make the patient, in the opinion of the investigator, unsuitable for the study.
- History of cardiovascular disease (eg, coronary heart disease, hypertension, Raynaud's phenomenon, orthostatic hypotension, thromboangiitis), cerebrovascular (eg, cerebral insufficiency), active liver or kidney, severe, unstable or uncontrolled that would prevent the safe administration of an alpha-adrenergic topic or CAI in the opinion of the investigator.
- Related to previous or concomitant medications
- Patients with recent use (within 4 weeks of Visit Eligibility 1) salicylate therapy with high dose (> 1 g daily).
- Current or planned treatment with any psychotropic drug that increases the adrenergic response (eg, desipramine, amitriptyline).
- Concomitant use of monoamine oxidase inhibitors.
- Therapy with another investigational agent within 30 days prior to the Screening Visit.
- Hypersensitivity to the drug alpha-adrenergic agonists, oral or topical CAIs, sulfonamide derivatives or any component of the study drugs in the opinion of the investigator.
- Less than 30 days regimen with stable administration before the Screening Visit any medications or substances administered by any route and used chronically that may affect IOP, including among others, β-adrenergic blocking agents.
- Use of ocular hypotensive medication any additional topical or systemic throughout the study.
- Concomitant use of glucocorticoids administered by any route.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Department of Ophthalmology / Hospital São Paulo
São Paulo, São Paulo, 04023062
About this study
Official title: Safety and Efficacy to Reduce the IOP of the Fixed Association of Latanoprost 0.005% (50 μg/mL)/ Brinzolamide 1% (10mg/mL) Drops, Compared to Latanoprost 0.005% (50 μg/mL) Drops, in Patients With Open Angle Glaucoma or Ocular Hypertension
This study is a double-masked, randomized, parallel group study in patients with open angle glaucoma or ocular hypertension.
The aim of this study is to verify the efficacy of the fixed combination of Latanoprost 50 mcg / mL / brinzolamide 10mg/ml eye drops compared to Latanoprost 50μg/mL eye drops in reducing IOP
Read the detailed description
The study is divided into two sequential phases. The Phase I trial is a Phase Screening / Eligibility, which includes a screening visit, followed by 2 Visits Eligibility (3 visits). The Phase II study is the treatment phase randomized, double-masked that includes visits during therapy at Week 2, Week 6 and Month 3
- Conditions
- Open Angle Glaucoma, Ocular Hypertension
- Being tested
- Latanoprost+Brinzolamide combination, Latanoprost
- Keywords
- glaucoma, ocular hypertension, latanoprost, brinzolamide
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Latanoprost+Brinzolamide combinationDrug
Also called Latanoprost 0.005% (50 mg / ml) / brinzolamide 1% (10mg/ml) eye drops
1 drop in each eye, 1x/day, at 9PM
LatanoprostDrug
Also called Latanoprost 0.005% (50 mg / ml)
1 drop in each eye, 1x/day, at 9PM
| Study group | Role | What they receive |
|---|---|---|
| Latanoprost+Brinzolamide combination | Experimental | Latanoprost 0.005%(50 mg/ml)+brinzolamide 1%(10mg/ml) eye drops Receives: Drug: Latanoprost+Brinzolamide combination |
| Latanoprost | Active comparator | Latanoprost 0.005% (50 mg / ml) Receives: Drug: Latanoprost |
What is being measured
The primary outcome is the main question the study is designed to answer.
IOP
Change in mean diurnal IOP compared to baseline (Month 3)
Measured: Month 3
Secondary outcomes (2)
IOP changes
Change in mean IOP from baseline (week 2, week 6, month 3)
Measured: week 2, week 6, month 3
IOP measures
Percentage of patients with IOP <18 mmHg at each visit during therapy and timepoint (week 2, week 6, month 3)
Measured: week 2, week 6, month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2012 (estimated)
- Study startDec 2012
- Primary completionMar 2013 (estimated)
- Study completionJun 2013 (estimated)
Why it stopped: withdrawn by industry
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adapt Produtos Oftalmológicos Ltda.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rubens Belfort Jr, MD, Principal investigator, Federal University of São Paulo / Hospital São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01721707
- Sponsor's protocol ID
- BRINZLAT-12
- Other IDs
- 08233812.4.0000.5505
- Status last verified
- Dec 2014
- First submitted
- 2 Nov 2012
- Last updated
- 11 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy to Reduce the IOP of the Fixed Association of Latanoprost 0.005% (50 μg/mL)/ Brinzolamide 1% (10mg/mL) Drops, Compared to Latanoprost 0.005% (50 μg/mL) Drops, in Patients With Open Angle Glaucoma or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT01721707
- Acronym / sponsor ID
- BRINZLAT-12
- Conditions
- Open Angle Glaucoma, Ocular Hypertension
- Keywords
- glaucoma, ocular hypertension, latanoprost, brinzolamide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: withdrawn by industry
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Adapt Produtos Oftalmológicos Ltda.Industry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 6 Nov 2012 (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 a double-masked, randomized, parallel group study in patients with open angle glaucoma or ocular hypertension.
The aim of this study is to verify the efficacy of the fixed combination of Latanoprost 50 mcg / mL / brinzolamide 10mg/ml eye drops compared to Latanoprost 50μg/mL eye drops in reducing IOP
Detailed description
The study is divided into two sequential phases. The Phase I trial is a Phase Screening / Eligibility, which includes a screening visit, followed by 2 Visits Eligibility (3 visits). The Phase II study is the treatment phase randomized, double-masked that includes visits during therapy at Week 2, Week 6 and Month 3
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Latanoprost+Brinzolamide combination | Experimental | Drug: Latanoprost+Brinzolamide combinationLatanoprost 0.005%(50 mg/ml)+brinzolamide 1%(10mg/ml) eye drops |
| Latanoprost | Active comparator | Drug: LatanoprostLatanoprost 0.005% (50 mg / ml) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients 18 years of age or older, of either gender and of any race / ethnicity, diagnosed with open angle glaucoma or ocular hypertension, which in the opinion of the investigator does not have enough control with monotherapy or already receiving multiple medications for lowering IOP .
- Patients should be able to understand and sign an informed consent form that has been approved by an Institutional Review Board.
- Measurements of mean IOP in at least 1 eye:
- The mean IOP should not be> 36 mmHg at any timepoint
Key exclusion criteria (29 listed)
- Fertile women (those not surgically sterile or postmenopausal for at least 1 year) are excluded from study participation if meet any of the following conditions:
- Patients with angle Schaffer Grade <2, as measured by gonioscopy (extreme narrow angle with complete or partial closure).
- Patients with a ratio cup / disc greater than 0.80 (horizontal or vertical).
- Patients presenting with loss of central visual field impairment. The loss of central visual field is defined as a serious sensitivity less than or equal to 10 dB in at least four points of two visual field test closest to the point of attachment.
- Patients who can not safely discontinue use of all medications to ocular IOP reduction for a minimum of 5 days ± 1 day to 28 days ± 1 day prior to Visit E1.
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 |
|---|---|---|
| Latanoprost+Brinzolamide combinationAlso: Latanoprost 0.005% (50 mg / ml) / brinzolamide 1% (10mg/ml) eye drops1 drop in each eye, 1x/day, at 9PM | Drug | Latanoprost+Brinzolamide combination |
| LatanoprostAlso: Latanoprost 0.005% (50 mg / ml)1 drop in each eye, 1x/day, at 9PM | Drug | Latanoprost |
Primary outcome
IOP
Time frame: Month 3
Change in mean diurnal IOP compared to baseline (Month 3)
2 secondary outcomes
IOP changes
Time frame: week 2, week 6, month 3
IOP measures
Time frame: week 2, week 6, month 3
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2014.
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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.
Rubens Belfort Jr, MD principal investigator
Federal University of São Paulo / Hospital São Paulo
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 Latanoprost+Brinzolamide combination and Latanoprost in people with Open Angle Glaucoma and Ocular Hypertension, run by Adapt Produtos Oftalmológicos Ltda. at 1 site in Brazil.
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 29 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: withdrawn, as of the sponsor's last update on 11 Dec 2014. 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 Brazil. 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 was withdrawn before enrolling participants, so there are no results.
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?
IOP (time frame: Month 3). 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 Dec 2014.