Intraocular hypertension MedDRA version: 8.1 Level: LLT Classification code 10021667 Term: Increased intraocular pressure
Conditions
Interventions
Product Name: DNB-001
Product Code: DNB-001
Pharmaceutical Form: Capsule, hard
CAS Number: 335381-68-5
Current Sponsor code: DNB-001
Other descriptive name: KR-31378
Concentration unit: mg milligram(s
Sponsors
Danube Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Male or female, at least 18 years of age 2.Patients with ocular hypertension in both eyes 3.Best corrected ETDRS visual acuity score equivalent to a Snellen score of 20/50 or better in each eye 4.Written informed consent prior to any study procedure 5.Ability and willingness to follow study instructions and likely to complete all study visits 6. Screening (day -30 ~ -1) negative urine pregnancy test for all female patients prior to entry into the study, unless they are postmenopausal for at least one year and/or hysterectomised and/or have a documented medical history of clinical inability to become pregnant. 7.Screening (day -30 ~ -1) IOP higher or equal to 21 mm Hg and = 29 mm Hg in each eye 8.Body mass index (BMI) between 18.5 and 30 kg/m² 9.Patients who are healthy as determined by pre-study medical history, physical examination and the absence of protocol-specified ECG abnormalities on the Visit 1 ECG 10.Patients who had clinical laboratory tests within the reference ranges or clinically acceptable to the investigator 11.Subjects who are negative for hepatitis B surface antigen (HBsAg) and hepatitis C antibody 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.Prior diagnosis of glaucoma of any type 2.Subjects with uncontrolled systemic disease of any type. Patients receiving insulin for diabetes mellitus will not be admitted to the study 3.All female patients of childbearing potential. Participating females need to be postmenopausal for at least one year and/or hysterectomised and/or need to have a documented medical history of clinical inability to become pregnant. Male patients have to use barrier contraception (condoms plus spermicidal jelly) during the study or have to be surgically sterile 4.Use of any ocular anti-hypertensive medication, topical or systemic in the past 3 months from screening date 5.Known allergy or sensitivity to the study medications 6.Anticipated alteration in chronic therapy with or introduction of agents known to have a substantial effect on IOP (e.g. beta-adrenergic blocking agents) 7. Corneal abnormalities that would interfere with accurate IOP readings with an applanation tonometer 8.Use of oral, injectable or topical ophthalmic steroid within the past 21 days from screening date 9. History of ocular allergy 10. Any active ocular disease (e.g. uveitis, ocular infection, severe dry eye). Patients may have cataracts, age-related macular degeneration or background diabetic retinopathy if, in the opinion of the Investigator, it would not interfere with the conduct of the study 11. Required use of ocular medication (including artificial tears) during the study 12. Significant visual field loss or progressive field loss during the past year. 13. Significant optic nerve abnormality in the opinion of the Investigator as determined by ophthalmoscopy 14. Presence of optic nerve head haemorrhage 15. Gonioscopy consistent with potential angle closure glaucoma 16. Intraocular surgery within the past 6 months from screening date 17. Past history of any laser or filtering surgery for glaucoma 18. Refractive surgery of any type within the past 3 months from screening date 19. Inability to visualise the patient’s optic nerve 20. Any abnormal lab values at Screening related to liver function (e.g. aspartate aminotransferase [AST], alanine aminotransferase [ALT], alkaline phosphatase [ALP] or bilirubin) 21. Anticipated change in dosage of or introduction of new medications for chronic cardiac, pulmonary or hypertensive conditions 22. Anticipated change in over-the-counter medications, vitamins or herbal products during the course of the study 23. Use of acetaminophen (paracetamol) during the study 24. Current enrolment in an investigational drug or device study or participation in such a study within 30 days of screening 25. History of drug or alcohol abuse within the past one year 26. Patient has any condition or situation that, in the Investigator’s opinion, might confound the results of the study, may put the patient at significant risk or might interfere with the patient’s ability to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective: To evaluate the efficacy of 100, 250, 500 and 750 mg of DNB-001 bid p.o. as anti-ocular hypertensive agents compared with placebo administered bid po for 28 days in patients with ocular hypertension. ;Secondary Objective: Secondary objectives: To evaluate the safety and pharmacokinetic profile of DNB-001 administered p.o. for 28 days in patients with ocular hypertension. PK objectives: The primary PK objective is to test for accumulation by intra-individual comparisons of weekly measurements of plasma concentration of DNB-001 at 2 hrs post a.m. dose The secondary PK objective is to compare weekly measurements of plasma concentration of DNB-001 at 2 hrs post a.m. dose between treatment groups The PK variable is: weekly measurement of the plasma concentration of DNB-001 at 2 hrs post a.m. dose. ;Primary end point(s): The primary efficacy variable is defined as the percentage change of IOP from baseline (at 10 a.m. [+/- 1 hr] prior to the study medication) up to Visit 6 (Day 28) at Hour 2 ([+/- 1 hr) post a.m. dosing under treatment with DNB-001 or placebo. The reduction of IOP is calculated on the basis of the arithmetic mean of up to six IOP measurements (3 IOP measurements per eye) | — |
Countries
Czech Republic, United Kingdom
Outcome results
None listed