Open-angle glaucoma (OAG) or ocular hypertension (OHT) MedDRA version: 20.0 Level: SOC Classification code 10015919 Term: Eye disorders System Organ Class: 10015919 - Eye disorders MedDRA version: 20.0 Level: PT Classification code 10030348 Term: Open angle glaucoma System Organ Class: 10015919 - Eye disorders MedDRA version: 20.0 Level: PT Classification code 10030043 Term: Ocular hypertension System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Product Name: brinzolamide 10 mg/mL + brimonidine tartrate 2 mg/mL
Pharmaceutical Form: Eye drops, suspension
INN or Proposed INN: BRINZOLAMIDE
CAS Number: 138890-62-7
Concentration unit: mg/ml milli
Sponsors
Pharmathen S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For inclusion in the study subjects should fulfill ALL of the following criteria: •Female or male outpatients, of any race or ethnicity, aged at least 18 years at the time of signing the ICF •Patients diagnosed with bilateral or unilateral open-angle glaucoma (including open-angle glaucoma with pseudoexfoliation or pigment dispersion) and/or ocular hypertension for whom, as per the investigator’s clinical judgment, monotherapy provides insufficient IOP reduction • Patients who are able to safely discontinue use of all ocular hypotensive medication(s) and undergo appropriate washout period • Mean IOP measurements in at least one (1) eye (the same eye), must be: =24 mmHg and =36 mmHg at the 09:00 a.m. time point, and =21 and =36 mmHg at the 11:00 a.m. time point at both the Eligibility 1 and Eligibility 2 visits after the required washout of any IOP-lowering medication. •Mean IOP must be =36 mmHg in both eyes at both time points (09:00 a.m. and 11:00 a.m.) of the two Eligibility visits •If females of childbearing potential, willingness to use an acceptable form of birth control during the clinical trial •Patients who are able to comprehend and willing to follow the requirements of the study (including availability on scheduled visit dates) •Patients who are able to understand and willing to provide voluntary written informed consent before any clinical trial-related procedure is performed. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients who meet ANY of the following criteria will be excluded from the study: •Females who are pregnant, breast feeding, or planning to become pregnant •Females of childbearing potential who do not agree to utilize an adequate form of contraception •Schaffer angle grade 620 µm as measured by pachymetry in either eye •Cup-to-disk ratio (CDR) >0.80 (horizontal or vertical measurement) in either eye •Severe central visual field loss (i.e., sensitivity =10 decibel [dB] in at least 2 of the 4 visual field test points closest to the point of fixation) in either eye •Chronic, recurrent, or current severe inflammatory eye disease (e.g., scleritis, uveitis, herpes keratitis) in either eye •Ocular infection or ocular inflammation within the past 3 months prior to the Screening visit •Ocular trauma within the past 6 months prior to the Screening visit •Clinically significant or progressive retinal disease (e.g., retinal degeneration, diabetic retinopathy, retinal detachment) in either eye •Other ocular pathology (including severe dry eye) in either eye that may, in the opinion of the Investigator, preclude the safe administration of a topical ocular alpha-adrenergic agonist and/or a topical carbonic anhydrase inhibitor •Intraocular surgery (e.g., cataract surgery) within the past 6 months prior to the Screening visit •Refractive surgery, filtering surgery, or laser surgery for IOP reduction within the past 12 months prior to the Screening visit •Planned ocular surgery of any kind during study participation •Any abnormality that would prevent accurate IOP readings with the applanation tonometry •Best corrected visual acuity (BCVA) score worse than 55 ETDRS (Early Treatment Diabetic Retinopathy Study) letters (equivalent to approximately 20/80 Snellen, 0.60 logMAR or 0.25 decimal) in either eye •Severe illness or other condition that would make the patient, in the opinion of the Investigator, unsuitable for the study •Patients with severe renal impairment (creatinine clearance [CrCl] 1 gram daily) salicylate therapy monoamine oxidase (MAO) inhibitor therapy any antidepressant which affects noradrenergic transmission (e.g., tricyclic antidepressants, mianserin) adrenergic-augmenting psychotropic drug (e.g., desipramine, amitriptyline) any other medication that augments adrenergic response or precludes use of an alpha-adrenergic agonist •Use within 2 weeks prior to Eligibility 1 visit of topical ophthalmic corticosteroid or topical corticosteroid •Use within 6 months prior to Eligibility 1 visit of intravitreal or subtenon injection of ophthalmic corticosteroid •Use at any time prior to Eligibility 1 visit of intraocular corticosteroid implant •Patients who currently receive treatment with any investigational drug/device/intervention or who have received any investigational product within 30 days or 5 half-lives of the investigational agent (whichever is longer) before the scree
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that the generic BBFC 1%/0.2% ophthalmic suspension BID/Pharmathen (test product) is non-inferior to SIMBRINZA® (BBFC 1%/0.2% ophthalmic suspension BID)/Alcon (reference product) with respect to IOP-lowering efficacy at Month 3, in adult patients with OAG or OHT.;Secondary Objective: To compare the safety and tolerability profile of the generic BBFC 1%/0.2% ophthalmic suspension BID/Pharmathen (test product) versus SIMBRINZA® (BBFC 1%/0.2% ophthalmic suspension BID)/Alcon (reference product) with respect to treatment-emergent ocular and systemic AE and adverse drug reaction (ADR) occurrence and treatment discontinuation due to ADR occurrence over the 3-month treatment period, in adult patients with OAG or OHT. ;Primary end point(s): •Difference between the test and reference product in the mean change from baseline in diurnal IOP at Month 3 (patient IOP changes averaged over the 09:00 a.m. and 11:00 a.m. time points). ;Timepoint(s) of evaluation of this end point: At Month 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Difference between the test and reference product in the mean change from baseline in IOP at 09:00 a.m. at Month 3 •Difference between the test and reference product in the mean change from baseline in IOP at 11:00 a.m. at Month 3 •Difference between the test and reference product in the mean change from baseline in diurnal IOP at Week 6 •Difference between the test and reference product in the mean change from baseline in IOP at 09:00 a.m. at Week 6 •Difference between the test and reference product in the mean change from baseline in IOP at 11:00 a.m. at Week 6 •Difference between the test and reference product in the mean change from baseline in diurnal IOP at Week 2 •Difference between the test and reference product in the mean change from baseline in IOP at 09:00 a.m. at Week 2 •Difference between the test and reference product in the mean change from baseline in IOP at 11:00 a.m. at Week 2. •Incidence of serious and non-serious treatment-emergent ocular and systemic AEs and ADRs in the two treatment arms (patients administered the test product and the reference product) •Proportions of patients with permanent treatment discontinuation due to ADRs during the study treatment period, in the two treatment arms.;Timepoint(s) of evaluation of this end point: Week 2 and Week 6 post-treatment onset | — |
Countries
Greece
Contacts
Public ContactClinical Affairs Specialist
Pharmathen S.A.
Outcome results
None listed