Ocular hypertension or open angle glaucoma
Conditions
Interventions
Product Name: BVT.28949
Pharmaceutical Form: Eye drops, solution
CAS Number: 651047-49-3
Current Sponsor code: BVT.28949
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: up to
Con
Sponsors
Biovitrum AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients, =18 years of age, diagnosed with ocular hypertension or open angle glaucoma (OAG), either untreated or controlled on mono-therapy. 2. Treatment-naïve patients with a mean morning IOP of =21 mmHg to =30 mmHg in each separate eye at screening2 (Visit 2) and a diurnal IOP at randomization (Visit 3) of =21 mmHg to = 30 mmHg in both eyes at randomization (Visit 3), or patients on mono-therapy for treatment of OH or OAG with a mean morning IOP of =17 mmHg to =30 mmHg in each separate eye at screening (Visit 1) and a diurnal IOP of =21 mmHg to =30 mmHg in both eyes after wash-out (at randomization, Visit 3). 3. Best corrected visual acuity score of 20/80 by Snellen (0.6 logMAR) acuity measurement, or better, in both eyes. 4. Signed informed consent to participate in this study. 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: 1. Previous ocular surgery, including laser procedures, affecting the trabecular meshwork or cornea without time limit, as well as other kinds of ocular surgery, including laser procedures, if performed less than 6 months before randomization. 2. Anticipated need to initiate or modify medication (systemic or topical) that is known to affect IOP (e.g. beta-adrenergic antagonists, alfa-adrenergic agonists, calcium channel blockers, ACE inhibitors and angiotensin II receptor antagonists) during the study period. Dosage of such medication should not have been altered within 4 weeks prior to randomization. 3. Any condition in either eye that may prevent reliable applanation tonometry. 4. Anterior chamber angle less than grade 2 according to Shaffer classification as measured by gonioscopy. 5. Patients with advanced visual field defect in either eye. For Humphery perimeter MD greater than -12.0 dB and Octopus perimeter MD score greater than +9.5. Or severe central visual field loss defined as a sensitivity of less than or equal to 10 dB in at least two of the four visual field test points closest to the point of fixation. 6. Patients with a cup/disc ratio greater than 0.8 in either eye on the horizontal or vertical measurement. 7. Use of contact lenses within 3 weeks prior to randomization and during the study. 8. Continuous use of ocular medication during the study period, other than the study medication. 9. History or presence of other abnormal ocular condition(s) or symptom(s) preventing the patient from entering the study, as judged by the investigator (e.g. uveitis, ocular inflammations/infections, or severe dry eye). 10. Myopia of -6 diopters or more. 11. Diabetes type I. 12. History or presence of clinically significant medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration, as judged by the investigator. 13. Females of childbearing potential. Note: All females must be surgically sterilized or postmenopausal (amenorrhea for at least 12 months). 14. Suspected or known drug or alcohol abuse within the past 12 months. 15. Enrolment in another concurrent investigational study or intake of an investigational drug within 12 weeks before randomization. 16. Inability to comply with or tolerate study procedures, including ocular examinations, as judged by the investigator. 17. Inability to understand or cooperate with given information, as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to compare mean reduction in diurnal IOP between each of the two groups receiving BVT.28949 (2 mg/mL, 7 mg/mL) and the placebo group after 4 weeks of treatment.;Secondary Objective: - To compare mean reduction in diurnal IOP between each of the two groups receiving BVT.28949 (2 mg/mL, 7 mg/mL) and the placebo group after 2 weeks of treatment. - To compare the differences in mean IOP reducing effect for the two groups receiving BVT.28949 (2 mg/mL, 7 mg/mL) and the placebo group for each time point during the 8-hour IOP assessment (i.e., at 8:00, 10:00, 12:00, 14:00, and 16:00) after 2 and 4 weeks of treatment, respectively, and for the 8:00 assessments also after 1 and 3 weeks of treatment. - To assess the ocular safety and tolerability of BVT.28949 by assessment of ocular adverse events and best corrected visual acuity and refraction. - To monitor the general safety and tolerability of BVT.28949 by assessment of adverse events, safety laboratory analyses, vital signs including pulse and blood pressure, and 12-lead ECG. ;Primary end point(s): Mean change of diurnal IOP of 2 mmHg | — |
Countries
Sweden
Outcome results
None listed