GlaucomaPhase 3NCT02512042
Bioequivalence Study With Clinical Endpoint Comparing Brinzolamide 1% Ophthalmic Suspension to Azopt® 1% Ophthalmic Suspension In the Treatment of Chronic Open Angle Glaucoma or Ocular Hypertension in Both Eyes
A Phase 3 study testing Test-Brinzolamide 1% Ophthalmic suspension and Reference-Brinzolamide 1% Ophthalmic suspension in people with Glaucoma, run by Actavis Inc. at 10 sites in United States.
Trial summary
This is a randomized, double blind, two-arm, parallel group, active controlled bioequivalence study, at multiple clinical trial sites designed to demonstrate bioequivalence of Brinzolamide 1% ophthalmic suspension (manufactured by Indoco Remedies Ltd. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Test-Brinzolamide 1% Ophthalmic suspension and Reference-Brinzolamide 1% Ophthalmic suspension
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 973 participants
- Where
- 10 sitesUnited States
- Study dates
- Apr 2015to May 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Male or non-pregnant females aged 18 years and above with a Body Mass Index (BMI) of 18.5 to 35 Kg/m2, with chronic open angle glaucoma or ocular hypertension in both eyes on stable ocular hypotensive treatment regimen.
- Subjects requiring treatment of both eyes and are able to discontinue use of all ocular hypotensive medication(s) or switch ocular hypotensive medications and undergo appropriate washout period.
- Adequate wash-out period prior to baseline of any ocular hypotensive medication. In order to minimize potential risk to subjects due to IOP elevations during the washout period, investigator may choose to substitute a parasympathomimetic or carbonic anhydrase inhibitor in place of a sympathomimetic, alpha-agonist, beta-adrenergic blocking agent, or prostaglandins. However, subjects must have discontinued all ocular hypotensive medication for the minimum washout period.
- Baseline (Day 0/hour 0) IOP ≥ 22 mm Hg and ≤ 34 mm Hg in each eye and any asymmetry of IOP between the eyes no greater than 5 mm Hg.
- Baseline best corrected visual acuity equivalent to 20/200 or better in each eye.
- Study subjects must have provided IRB approved written informed consent using the latest version of the IRB informed consent form. In addition, study subjects must sign a Health Insurance Portability and Accountability Act (HIPAA) authorization, if applicable.
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- Study subjects should be literate and willing to complete the subject diary regularly as directed.
- Study subjects must be in good health and free from any clinically significant disease apart from indication under study.
- Females of child bearing potential (WOCBP*) must not be pregnant or lactating at baseline visit (as documented by a negative serum pregnancy test with a minimum sensitivity of 25 IU/L or equivalent units of beta-human chorionic gonadotropin (Beta-HCG) at screening and urine pregnancy at baseline.
- All female subjects will be considered to be of childbearing potential unless they are postmenopausal. Female subjects of childbearing potential (WOCBP) are defined as sexually mature women without prior hysterectomy, or who have had any evidence of menses in the past 12 months. However, women who have been amenorrheic for the past 12 or more months are still considered to be of childbearing potential, if the amenorrhea is possibly due to other causes, including prior chemotherapy, anti-estrogens, or ovarian suppression. Postmenopausal women (defined as women who have been amenorrheic for at least 12 consecutive months, in the appropriate age group, without other known or suspected primary cause) or women who have been sterilized surgically or who are otherwise proven sterile (i.e., total hysterectomy, or bilateral oophorectomy with surgery at least 4 weeks prior to randomization) are not considered WOCBP. Subjects who have undergone tubal ligation are NOT considered as surgically sterile.
- Female subjects of childbearing potential must be willing to use an acceptable form of birth control from the day of the first dose administration to 30 days after the last administration of IP. For the purpose of this study the following are considered acceptable methods of birth control: oral or injectable contraceptives, contraceptive patches, Depo-Provera® (Medroxyprogesterone acetate- stabilized for at least 3 months); vaginal contraceptive; contraceptive implant; double barrier methods (e.g. condom and spermicide); Nuvaring vaginal hormonal birth control, IUD, or abstinence with a second method of birth control should the subject become sexually active. A sterile sexual partner is NOT considered an adequate form of birth control.
- All male subjects must agree to use accepted methods of birth control with their partners, from the day of the first dose administration (to 30 days after the last administration of study drug). Please see acceptable forms for "Female" birth control above. Abstinence is an acceptable method of birth control for males.
- Study subjects must be willing and able to understand and comply with the requirements of the protocol, including attendance at the required scheduled study visits.
- Study subjects must be willing to refrain from using any other treatments for Chronic Open Angle Glaucoma (COAG), other than the investigational product.
Who cannot join
- Females who are pregnant, breast feeding, or planning a pregnancy during the course of the study and for 30 days after last study dose.
- Females of childbearing potential who do not agree to utilize an adequate form of contraception.
- Current or past history of severe hepatic or renal impairment.
- Current or history within two months prior to baseline of significant ocular disease, e.g., corneal edema, uveitis, ocular infection, or ocular trauma in either eye.
- Current corneal abnormalities that would prevent accurate IOP readings with the Goldmann applanation tonometer e.g. corneal dystrophy, corneal abrasions, corneal ulcers, keratitis, keratoconus and keratoglobus.
- Functionally significant visual field loss
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- Contraindication to brinzolamide or sulfonamide therapy or known hypersensitivity to any component of brinzolamide or sulfonamide therapy
- Use at any time prior to baseline of intraocular corticosteroid implant.
- Use within one week prior to baseline of contact lens
- Use within two weeks prior to baseline of: 1) topical ophthalmic corticosteroid, or 2) topical corticosteroid
- Use within one month prior to baseline of: 1) systemic corticosteroid or 2) high-dose salicylate therapy defined as 325mg taken on three consecutive days.
- Use within six months prior to baseline of intravitreal or subtenon injection of ophthalmic corticosteroid
- Underwent within six months prior to baseline any other intraocular surgery (e.g., cataract surgery)
- Underwent within twelve months prior to baseline: refractive surgery, filtering surgery or laser surgery for IOP reduction
- Amblyopia - only one sighted eye
- Severe retinal disease or other severe ocular pathology, such as glaucomatous damage with a cup/disc ratio greater than 0.8, split fixation, or functionally significant (in the investigators' opinion) visual field loss
- History or presence of significant alcoholism or drug abuse in the past one year
- History or presence of significant smoking (more than 20 cigarettes or any other equivalent tobacco product/day)
- History of hematologic disorders other than mild anemia
- Severe, unstable, or uncontrolled cardiovascular or pulmonary disease
- Systolic blood pressure less than 90 mm Hg or more than 140 mm Hg, Diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg and Pulse rate less than 50 beats/minute or more than 100 beats/minute
- Any form of glaucoma other than chronic open-angle glaucoma
- Therapy with an investigational agent within the past 30 days
- Clinically significant hematologic and / or biochemical abnormalities based on laboratory testing
- Subjects who are in the investigator's best judgment at risk of visual field or visual acuity worsening as a consequence of participation of trial.
- Chronic use of any systemic medication that may affect IOP with less than three month stable dosing regimen (i.e., sympathomimetic agents, beta-adrenergic blocking agents, alpha agonists, alpha-adrenergic blocking agents, calcium channel blockers, angiotensin -converting enzyme inhibitors, etc.)
- Use of any prescribed medication during last two weeks or Over the Counter (OTC) medicinal products during the last one week preceding the first dosing that is affecting the IOP or result in drug-drug interaction with the study drug.
- Major illness, as per investigator discretion, during 3 months before screening
- Subjects who are employees of site or Clinical research organization (CRO) or sponsor or immediate family of employees
- Participating in a clinical study within the past 3 months.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Keystone Research Ltd.
Austin, Texas, 78731
Las Vegas Physicians Research Group
Henderson, Nevada, 89074
Shettle Eye Research, Inc.
Largo, Florida, 33773
AMB Research Center, Inc.
Miami, Florida, 33144
Eye Care Centers Management, Inc.
Morrow, Georgia, 30260
David Wirta, MD
Newport Beach, California, 92663
Coastal Research Associates, LLC
Roswell, Georgia, 30076
Keystone Research Ltd.
San Antonio, Texas, 78240
Heart of America Eye Care PA
Shawnee Mission, Kansas, 66204
Ophthalmology Associates
St Louis, Missouri, 63131
About this study
Official title: A Multicentre, Double Blind, Active Controlled, Parallel Group, Two Arm, Bioequivalence Study With Clinical Endpoint Comparing Brinzolamide 1% Ophthalmic Suspension (Manufactured by Indoco Remedies Ltd. for Watson Pharma Pvt Ltd.), to Brinzolamide (Azopt®) 1% Ophthalmic Suspension of Alcon Laboratories, Inc., In the Treatment of Chronic Open Angle Glaucoma or Ocular Hypertension in Both Eyes
This is a randomized, double blind, two-arm, parallel group, active controlled bioequivalence study, at multiple clinical trial sites designed to demonstrate bioequivalence of Brinzolamide 1% ophthalmic suspension (manufactured by Indoco Remedies Ltd. for Watson Pharma Pvt Ltd.), to Brinzolamide (Azopt®) 1% ophthalmic suspension of Alcon Laboratories, Inc. in the treatment of chronic open angle glaucoma or ocular hypertension in both eyes.
Read the detailed description
Study will be conducted in adult subjects, above 18 years inclusive, males and non pregnant females, diagnosed with chronic open angle glaucoma or ocular hypertension in both eyes. Qualifying Intra Ocular Pressure (IOPs) following wash-out, at baseline (Day 0/hour 0 i.e., 8:00 am) should be ≥ 22 milli meter mercury (mm Hg) and ≤ 34 mm Hg in each eye and any asymmetry of IOP between the eyes no greater than 5 mm Hg.
Each study subject will use one drop of test or reference Ophthalmic Suspension in both the eyes three times daily at approximately 8:00am, 04:00 pm and 10:00 pm for 42 days (6 weeks). The dose and mode of treatment chosen in this study is the dosage approved by United States Food and Drug administration (US FDA) for use in treatment of patients of Chronic Open Angle Glaucoma.
The study subjects will undergo clinical evaluations throughout the study in order to assess efficacy and safety. Study subject primary endpoint evaluation will be assessed after 2 weeks (14 days) and 6 weeks (42 days) of treatment for each study subject deemed eligible for evaluation, (i.e., at Visit III - Day 14 ± 2 days and Visit IV - Day 42 ± 3 days).
The primary bioequivalence comparison is between the test and reference products for the mean difference in intraocular pressure (IOP) of both eyes at four time points, i.e., at approximately 8:00 am and 10:00 am at the Day 14 (± 2 days) and Day 42 (± 3 days) visits.
- Conditions
- Glaucoma
- Being tested
- Test-Brinzolamide 1% Ophthalmic suspension, Reference-Brinzolamide 1% Ophthalmic suspension
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test-Brinzolamide 1% Ophthalmic suspensionDrug
Reference-Brinzolamide 1% Ophthalmic suspensionDrug
| Study group | Role | What they receive |
|---|---|---|
| Brinzolamide 1% Ophthalmic suspension | Experimental | Brinzolamide Pharmaceutical dosage form: Ophthalmic suspension Strength: 1% Manufactured by: Indoco Remedies, Ltd for Watson Pharma Pvt. Ltd Receives: Drug: Test-Brinzolamide 1% Ophthalmic suspension |
| Azopt® 1% Ophthalmic suspension | Active comparator | Azopt® (Contains Brinzolamide) Pharmaceutical dosage form: Ophthalmic suspension Strength: 1% Manufactured by: Alcon Laboratories, Inc Receives: Drug: Reference-Brinzolamide 1% Ophthalmic suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Difference in Intraocular Pressure (IOP) of Both Eyes Between the Two Treatment Groups at Four Time Points
The primary efficacy end point is the mean difference in intraocular pressure (IOP) of both eyes between the two treatment groups at four time points, i.e., at approximately 8:00 am (hour 0; before the morning drop) and 10:00 am (hour 2; after the morning drop) at the Day 14 (week 2) and Day 42 (week 6) visits
Measured: Day 14 and 42 at 8AM and 10AM
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2015 (estimated)
- Study startApr 2015
- Primary completionApr 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 973 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actavis Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02512042
- Sponsor's protocol ID
- WAT/BNZL/2014
- Status last verified
- Feb 2020
- First submitted
- 23 Jul 2015
- Last updated
- 2 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Double Blind, Active Controlled, Parallel Group, Two Arm, Bioequivalence Study With Clinical Endpoint Comparing Brinzolamide 1% Ophthalmic Suspension (Manufactured by Indoco Remedies Ltd. for Watson Pharma Pvt Ltd.), to Brinzolamide (Azopt®) 1% Ophthalmic Suspension of Alcon Laboratories, Inc., In the Treatment of Chronic Open Angle Glaucoma or Ocular Hypertension in Both Eyes
- ClinicalTrials.gov ID
- NCT02512042
- Acronym / sponsor ID
- WAT/BNZL/2014
- Conditions
- Glaucoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 973 participants (actual)
- Lead sponsor
- Actavis Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2015 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 30 Jul 2015 (estimated)
- Results
- Posted 2 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, double blind, two-arm, parallel group, active controlled bioequivalence study, at multiple clinical trial sites designed to demonstrate bioequivalence of Brinzolamide 1% ophthalmic suspension (manufactured by Indoco Remedies Ltd. for Watson Pharma Pvt Ltd.), to Brinzolamide (Azopt®) 1% ophthalmic suspension of Alcon Laboratories, Inc. in the treatment of chronic open angle glaucoma or ocular hypertension in both eyes.
Detailed description
Study will be conducted in adult subjects, above 18 years inclusive, males and non pregnant females, diagnosed with chronic open angle glaucoma or ocular hypertension in both eyes. Qualifying Intra Ocular Pressure (IOPs) following wash-out, at baseline (Day 0/hour 0 i.e., 8:00 am) should be ≥ 22 milli meter mercury (mm Hg) and ≤ 34 mm Hg in each eye and any asymmetry of IOP between the eyes no greater than 5 mm Hg.
Each study subject will use one drop of test or reference Ophthalmic Suspension in both the eyes three times daily at approximately 8:00am, 04:00 pm and 10:00 pm for 42 days (6 weeks). The dose and mode of treatment chosen in this study is the dosage approved by United States Food and Drug administration (US FDA) for use in treatment of patients of Chronic Open Angle Glaucoma.
The study subjects will undergo clinical evaluations throughout the study in order to assess efficacy and safety. Study subject primary endpoint evaluation will be assessed after 2 weeks (14 days) and 6 weeks (42 days) of treatment for each study subject deemed eligible for evaluation, (i.e., at Visit III - Day 14 ± 2 days and Visit IV - Day 42 ± 3 days).
The primary bioequivalence comparison is between the test and reference products for the mean difference in intraocular pressure (IOP) of both eyes at four time points, i.e., at approximately 8:00 am and 10:00 am at the Day 14 (± 2 days) and Day 42 (± 3 days) visits.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brinzolamide 1% Ophthalmic suspension | Experimental | Drug: Test-Brinzolamide 1% Ophthalmic suspensionBrinzolamide Pharmaceutical dosage form: Ophthalmic suspension Strength: 1% Manufactured by: Indoco Remedies, Ltd for Watson Pharma Pvt. Ltd |
| Azopt® 1% Ophthalmic suspension | Active comparator | Drug: Reference-Brinzolamide 1% Ophthalmic suspensionAzopt® (Contains Brinzolamide) Pharmaceutical dosage form: Ophthalmic suspension Strength: 1% Manufactured by: Alcon Laboratories, Inc |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male or non-pregnant females aged 18 years and above with a Body Mass Index (BMI) of 18.5 to 35 Kg/m2, with chronic open angle glaucoma or ocular hypertension in both eyes on stable ocular hypotensive treatment regimen.
- Subjects requiring treatment of both eyes and are able to discontinue use of all ocular hypotensive medication(s) or switch ocular hypotensive medications and undergo appropriate washout period.
- Adequate wash-out period prior to baseline of any ocular hypotensive medication. In order to minimize potential risk to subjects due to IOP elevations during the washout period, investigator may choose to substitute a parasympathomimetic or carbonic anhydrase inhibitor in place of a sympathomimetic, alpha-agonist, beta-adrenergic blocking agent, or prostaglandins. However, subjects must have discontinued all ocular hypotensive medication for the minimum washout period.
- Baseline (Day 0/hour 0) IOP ≥ 22 mm Hg and ≤ 34 mm Hg in each eye and any asymmetry of IOP between the eyes no greater than 5 mm Hg.
- Baseline best corrected visual acuity equivalent to 20/200 or better in each eye.
Key exclusion criteria (30 listed)
- Females who are pregnant, breast feeding, or planning a pregnancy during the course of the study and for 30 days after last study dose.
- Females of childbearing potential who do not agree to utilize an adequate form of contraception.
- Current or past history of severe hepatic or renal impairment.
- Current or history within two months prior to baseline of significant ocular disease, e.g., corneal edema, uveitis, ocular infection, or ocular trauma in either eye.
- Current corneal abnormalities that would prevent accurate IOP readings with the Goldmann applanation tonometer e.g. corneal dystrophy, corneal abrasions, corneal ulcers, keratitis, keratoconus and keratoglobus.
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 |
|---|---|---|
| Test-Brinzolamide 1% Ophthalmic suspension | Drug | Brinzolamide 1% Ophthalmic suspension |
| Reference-Brinzolamide 1% Ophthalmic suspension | Drug | Azopt® 1% Ophthalmic suspension |
Primary outcome
Mean Difference in Intraocular Pressure (IOP) of Both Eyes Between the Two Treatment Groups at Four Time Points
Time frame: Day 14 and 42 at 8AM and 10AM
The primary efficacy end point is the mean difference in intraocular pressure (IOP) of both eyes between the two treatment groups at four time points, i.e., at approximately 8:00 am (hour 0; before the morning drop) and 10:00 am (hour 2; after the morning drop) at the Day 14 (week 2) and Day 42 (week 6) visits
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Test-Brinzolamide 1% Ophthalmic suspension and Reference-Brinzolamide 1% Ophthalmic suspension in people with Glaucoma, run by Actavis Inc. at 10 sites in United States.
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 14 inclusion and 30 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 2 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. 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?
Yes. Results are posted in the registry (first posted 2 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Difference in Intraocular Pressure (IOP) of Both Eyes Between the Two Treatment Groups at Four Time Points (time frame: Day 14 and 42 at 8AM and 10AM). 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 2 Mar 2020.