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    Summary
    EudraCT Number:2006-000168-10
    Sponsor's Protocol Code Number:BVT.28949-002
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-06-13
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSweden - MPA
    A.2EudraCT number2006-000168-10
    A.3Full title of the trial
    A 4-week, double-masked, parallel-group, randomized , multicenter, proof of concept study comparing the efficacy and safety of two dose levels of BVT.28949 with placebo in patients with ocular hypertension or open angle glaucoma.
    A.4.1Sponsor's protocol code numberBVT.28949-002
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBiovitrum AB
    B.1.3.4CountrySweden
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameBVT.28949
    D.3.4Pharmaceutical form Eye drops, solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOcular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 651047-49-3
    D.3.9.2Current sponsor codeBVT.28949
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number2
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Information not present in EudraCT
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameBVT.28949
    D.3.4Pharmaceutical form Eye drops, solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOcular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 651047-49-3
    D.3.9.2Current sponsor codeBVT.28949
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number7
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Information not present in EudraCT
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboEye drops, solution
    D.8.4Route of administration of the placeboOcular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Ocular hypertension or open angle glaucoma
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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.
    E.2.2Secondary objectives of the trial
    - 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.
    E.2.3Trial contains a sub-study No
    E.3Principal 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.
    E.4Principal 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.
    E.5 End points
    E.5.1Primary end point(s)
    Mean change of diurnal IOP of 2 mmHg
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Yes
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state70
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 126
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2006-08-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-08-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-12-06
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