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This is a randomized, Investigator-masked, multi-center, parallel group, therapeutic equivalence study with clinical endpoint.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BRIN-20-01 | Experimental |
| |
| Azopt® | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brinzolamide ophthalmic suspension | Drug | dose: one drop of study medication; frequency: three times a day; route of administration: Topical ocular administration; duration of therapy: 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Difference in Intraocular Pressure of Both Eyes Between the Two Treatment Groups | The recommended primary endpoint is the mean difference in Intraocular Pressure of both eyes between the two treatment groups at pre-specified time points. | Baseline, Week 2 & Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in IOP of Both Eyes Between the 2 Treatment Groups. | approximately 8:00 AM. (hour 0; before the morning drop) and 10:00 AM. (hour 2) at the Day 14 (Week 2) and Day 42 (Week 6) visits |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GMC, Srikakulam | Srikakulam | Andhra Pradesh | 532001 | India | ||
| Dr. RSPR Govt Regional Eye Hospital; Vishakapatnam |
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| ID | Title | Description |
|---|---|---|
| FG000 | BRIN-20-01 | Brinzolamide ophthalmic suspension: dose: one drop of study medication; frequency: three times a day; route of administration: Topical ocular administration; duration of therapy: 6 weeks |
| FG001 | Azopt® |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 12, 2021 | Dec 18, 2023 |
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| Azopt® | Drug | dose: one drop of study medication; frequency: three times a day; route of administration: Topical ocular administration; duration of therapy: 6 weeks |
|
| Visakhapatnam |
| Andhra Pradesh |
| 530013 |
| India |
| Rising Retina Clinic | Ahmedabad | Gujarat | 380015 | India |
| Bhavna Super speciality Eye care | Surat | Gujarat | 395002 | India |
| Dr. BR Ambedkar Medical College and hospital | Bangalore | Karnataka | 560045 | India |
| Bhagwan Mahaveer Jain Hospital | Bangalore | Karnataka | 560052 | India |
| KLE's Dr. Prabhakar Kore Hospital & Medical Research Center | Belagavi | Karnataka | 590010 | India |
| K R Hospital, Mysore Medical College and Research Institute | Mysuru | Karnataka | 570001 | India |
| Shanti Saroj Netralay | Miraj | Maharashtra | 416410 | India |
| Omkar Eye Care Center | Mumbai | Maharashtra | 400080 | India |
| Acharya Vinoba Bhave Rural Hospital, Jawaharlal Nehru Medical College, Datta Meghe Institute of Medical Sciences | Wardha | Maharashtra | 442004 | India |
| Sankara Nethralaya | Chennai | Tamil Nadu | 600006 | India |
| Dr Agarwal's Eye Hospital | Tirunelveli | Tamil Nadu | 627003 | India |
| Heritage Institute of Medical Sciences | Varanasi | Uttar Pradesh | 221005 | India |
| Institute of Human Brain of the Russian Academy of Science, 197376, Academ. Pavlov street 12 AP, StPetersburg, Russia | Saint Petersberg | Sankt-Peterburg | 197376 | Russia |
| Republican clinical ophthalmological hospital of Ministry of Health of Republic of Tatarstan named after E.V. Adamyuk | Kazan' | Tatarstan Republic | 420012 | Russia |
| Federal State Autonomous Institution "Interdistrict Scientific and Technical Complex "Eye Microsurgery" named after Academician S.N. Fedorov" of the Ministry of Healthcare of the Russian Federation | Cheboksary | 428028 | Russia |
| Healthcare Organization "Eye Center", Limited Liability Company | Chelyabinsk | 454000 | Russia |
| Federal State Autonomous Institution "Interdistrict Scientific and Technical Complex "Eye Microsurgery" named after Academician S.N. Fedorov" of the Ministry of Healthcare of the Russian Federation | Irkutsk | 664017 | Russia |
| Ivanovo Regional Clinical Hospital | Ivanovo | 152040 | Russia |
| "Eye Microsurgery" n a Academician S.N. Fedorov" | Kaluga | 248007 | Russia |
| Federal State Autonomous Institution "Interdistrict Scientific and Technical Complex "Eye Microsurgery" named after Academician S.N. Fedorov" of the Ministry of Healthcare of the Russian Federation | Khabarovsk | 680033 | Russia |
| "Angris", Limited Liability Company | Moscow | 117628 | Russia |
| Moscow Medical university n.a. Sechenov | Moscow | 119021 | Russia |
| Federal State Autonomous Institution "Interdistrict Scientific and Technical Complex "Eye Microsurgery" named after Academician S.N. Fedorov" of the Ministry of Healthcare of the Russian Federation | Moscow | 127486 | Russia |
| Federal State Budgetary Educational Institution of Higher Education "Moscow State University of Medicine and Dentistry named after A.I. Evdokimov" of the Ministry of Healthcare of the Russian Federation | Moscow | 127486 | Russia |
| "Moscow Regional Clinical Research Institute named after M.F. Vladimirsky" | Moscow | 129110 | Russia |
| Federal budgetary healthcare institution Privolzhsky district medical center FMBA of Russia. | Nizhny Novgorod | 603074 | Russia |
| Federal State Autonomous Institution "Interdistrict Scientific and Technical Complex "Eye Microsurgery" named after Academician S.N. Fedorov" of the Ministry of Healthcare of the Russian Federation | Novosibirsk | 630071 | Russia |
| Budgetary Healthcare Institution of the Omsk Region "Clinical Eye Hospital named after V.P. Vykhodtsev | Omsk | 644024 | Russia |
| Federal State Autonomous Institution "Interdistrict Scientific and Technical Complex "Eye Microsurgery" named after Academician S.N. Fedorov" of the Ministry of Healthcare of the Russian Federation | Saint Petersburg | 192283 | Russia |
| "X7 Clinical Research", Limited Liability Company | Saint Petersburg | 194156 | Russia |
| Feral State Budgetary Healthcare Institution "Clinical Hospital No. 122 named after L.G. Sokolov of the Federal Medical and Biological Agency" | Saint Petersburg | 194291 | Russia |
| Samara medical university | Samara | 443099 | Russia |
| Nongovernmental Healthcare Institution "Clinical Hospital "RZhD [Russian Railways]- | Saratov | 410004 | Russia |
| State Budgetary Institution "Ufa Research Institute of Eye Diseases of the Academy of Sciences of the Republic of Bashkortostan | Ufa | 450008 | Russia |
| ZAO "Optimedservice" | Ufa | 453128 | Russia |
| Ulyanovsk ophthalmology clinical "Prozrenie" | Ulyanovsk | 432001 | Russia |
| Federal Budgetary Healthcare Institution "Volga Region Medical Centre" of the Federal Medical and Biological Agency | Veliky Novgorod | 603001 | Russia |
| Federal State Autonomous Institution "Interdistrict Scientific and Technical Complex "Eye Microsurgery" named after Academician S.N. Fedorov" of the Ministry of Healthcare of the Russian Federation | Volgograd | 400138 | Russia |
Azopt®: dose: one drop of study medication; frequency: three times a day; route of administration: Topical ocular administration; duration of therapy: 6 weeks
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | BRIN-20-01 | Brinzolamide ophthalmic suspension: dose: one drop of study medication; frequency: three times a day; route of administration: Topical ocular administration; duration of therapy: 6 weeks |
| BG001 | Azopt® | Azopt®: dose: one drop of study medication; frequency: three times a day; route of administration: Topical ocular administration; duration of therapy: 6 weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Difference in Intraocular Pressure of Both Eyes Between the Two Treatment Groups | The recommended primary endpoint is the mean difference in Intraocular Pressure of both eyes between the two treatment groups at pre-specified time points. | Posted | Mean | Standard Deviation | mmHg | Baseline, Week 2 & Week 6 |
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in IOP of Both Eyes Between the 2 Treatment Groups. | Posted | Mean | Standard Deviation | mmHg | approximately 8:00 AM. (hour 0; before the morning drop) and 10:00 AM. (hour 2) at the Day 14 (Week 2) and Day 42 (Week 6) visits |
|
|
7 Weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BRIN-20-01 | Brinzolamide ophthalmic suspension: dose: one drop of study medication; frequency: three times a day; route of administration: Topical ocular administration; duration of therapy: 6 weeks | 0 | 297 | 0 | 297 | 49 | 297 |
| EG001 | Azopt® | Azopt®: dose: one drop of study medication; frequency: three times a day; route of administration: Topical ocular administration; duration of therapy: 6 weeks | 0 | 300 | 1 | 300 | 38 | 300 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertensive Crisis | Vascular disorders | MedDRA version 24.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | MedDRA version 24.0 | Systematic Assessment |
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| Abnormal Sensation in Eye | Eye disorders | MedDRA version 24.0 | Systematic Assessment |
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| Blepharitis | Eye disorders | MedDRA version 24.0 | Systematic Assessment |
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| Cataract | Eye disorders | MedDRA version 24.0 | Systematic Assessment |
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| Conjunctival Hyperemia | Eye disorders | MedDRA version 24.0 | Systematic Assessment |
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| Conjunctival Oedema | Eye disorders | MedDRA version 24.0 | Systematic Assessment |
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| Conjunctivitis Allergic | Eye disorders | MedDRA version 24.0 | Systematic Assessment |
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| Dry Eye | Eye disorders | MedDRA version 24.0 | Systematic Assessment |
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| Eye Irritation | Eye disorders | MedDRA version 24.0 | Systematic Assessment |
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| Eye Pain | Eye disorders | MedDRA version 24.0 | Systematic Assessment |
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| Eye Pruritus | Eye disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Foreign Body Sensation in Eyes | Eye disorders | MedDRA version 24.0 | Systematic Assessment |
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| Keratitis | Eye disorders | MedDRA version 24.0 | Systematic Assessment |
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| Lacrimation Increased | Eye disorders | MedDRA version 24.0 | Systematic Assessment |
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| Ocular Hyperemia | Eye disorders | MedDRA version 24.0 | Systematic Assessment |
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| Swelling of Eyelid | Eye disorders | MedDRA version 24.0 | Systematic Assessment |
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| Vision Blurred | Eye disorders | MedDRA version 24.0 | Systematic Assessment |
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| Visual Acuity Reduced | Eye disorders | MedDRA version 24.0 | Systematic Assessment |
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| Visual Impairment | Eye disorders | MedDRA version 24.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
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| Dry Mouth | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA version 24.0 | Systematic Assessment |
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| Instillation Site Dryness | General disorders | MedDRA version 24.0 | Systematic Assessment |
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| Instillation Site Pain | General disorders | MedDRA version 24.0 | Systematic Assessment |
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| Instillation Site Pruritus | General disorders | MedDRA version 24.0 | Systematic Assessment |
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| Instillation Site Reaction | General disorders | MedDRA version 24.0 | Systematic Assessment |
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| Malaise | General disorders | MedDRA version 24.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA version 24.0 | Systematic Assessment |
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| Conjunctivitis | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
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| Respiratory Tract Infection Viral | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
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| Ligament Sprain | Injury, poisoning and procedural complications | MedDRA version 24.0 | Systematic Assessment |
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| Blood Pressure Increased | Investigations | MedDRA version 24.0 | Systematic Assessment |
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| Intraocular Pressure Increased | Investigations | MedDRA version 24.0 | Systematic Assessment |
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| Hypercholesterolemia | Metabolism and nutrition disorders | MedDRA version 24.0 | Systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
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| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
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| Osteochondrosis | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
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| Breast Cyst | Reproductive system and breast disorders | MedDRA version 24.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
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| Respiratory Disorder | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA version 24.0 | Systematic Assessment |
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| Hypertensive Crisis | Vascular disorders | MedDRA version 24.0 | Systematic Assessment |
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The Sponsor has exclusive rights, including the right of authorship, to all publications concerning Study data and findings. The Institution, the Investigator, and the Co-Investigators are contractually bound not to make any publications, public statements, oral presentations concerning the Study data and findings.
The Sponsor shall have the sole right to review, use, publish, and disclose any data, information, or results developed without limitation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head-Clinical Development | Sun Pharmaceutical Industries Limited | 2266455645 | 5689 | clinical.trial@sunpharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 20, 2023 | Dec 18, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C111827 | brinzolamide |
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| Male |
|
| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Baseline - Left Eye 10:00 |
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| Baeline - Right Eye 10:00 |
|
| Week 2 - Left Eye 08:00 |
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| Week 2 - Right Eye 08:00 |
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| Week 2 - Left Eye 10:00 |
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| Week 2 - Right Eye 10:00 |
|
| Week 6 - Left Eye 08:00 |
|
| Week 6 - Right Eye 08:00 |
|
| Week 6 - Left Eye 10:00 |
|
| Week 6 - Right Eye 10:00 |
|
|
| Mean Difference (Final Values) |
| 0.19 |
| 2-Sided |
| 95 |
| -0.39 |
| 0.76 |
The reported mean difference represents value for Right Eye at Week 2, 08:00am |
| Equivalence |
Type of Statistical Test - Therapeutic equivalence. Sample size was based on 90% power at an alpha=0.05 significance level when the true difference between the means is 0 and SD=3.5 and the 95% equivalence limits are -1.0 and 1.0; 20% dropout was assumed |
| Mean Difference (Final Values) | -0.04 | 2-Sided | 95 | -0.59 | 0.50 | The reported mean difference represents value for Left Eye at Week 6, 08:00am | Equivalence | Type of Statistical Test - Therapeutic equivalence. Sample size was based on 90% power at an alpha=0.05 significance level when the true difference between the means is 0 and SD=3.5 and the 95% equivalence limits are -1.0 and 1.0; 20% dropout was assumed |
| Mean Difference (Final Values) | -0.12 | 2-Sided | 95 | -0.64 | 0.40 | The reported mean difference represents value for Right Eye at Week 6, 08:00am | Equivalence | Type of Statistical Test - Therapeutic equivalence. Sample size was based on 90% power at an alpha=0.05 significance level when the true difference between the means is 0 and SD=3.5 and the 95% equivalence limits are -1.0 and 1.0; 20% dropout was assumed |
|
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