Glaucoma MedDRA version: 14.0 Level: PT Classification code 10018304 Term: Glaucoma System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Product Name: Bimatoprost 0.03% PF ophthalmic solution
Product Code: 10037X
Pharmaceutical Form: Eye drops, solution
CAS Number: 155206-00-1
Current Sponsor code: 10037X
Concentration unit: mg/ml mill
Sponsors
Allergan Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients, 2 months (age adjusted for prematurity, if applicable, for children younger than 1 year postnatal) to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Uncontrolled systemic disease 2. Contraindications to beta-adrenoceptor antagonist therapy such as chronic obstructive pulmonary disease, bronchial asthma, history of bronchial asthma, sinus bradycardia, second and third degree atrioventricular block, overt cardiac failure or cardiogenic shock or uncontrolled congestive heart failure. Clearance for participation in the study from the patient’s primary paediatrician or primary care physician must be documented for all patients. 3. Clinically relevant low or high blood pressure or pulse rate for age as determined by the investigator 4. Females who are pregnant, nursing, or planning a pregnancy or who are of childbearing potential not using a reliable means of contraception throughout the study 5. Abnormally low body weight for age (below 5th percentile) 6. Patients in whom surgical intervention is indicated or anticipated for IOP lowering within 12 weeks after baseline. Note: Patients with primary congenital glaucoma will be excluded from the study unless surgery has already been performed. 7. Patients with lens-induced glaucoma, steroid-induced glaucoma, or retinoblastoma 8. Patients with secondary angle closure glaucoma due to anatomical abnormalities 9. Patients with secondary glaucoma associated with increased episcleral pressure (eg, Sturge-Weber, cavernous fistula, orbital disease) 10. Any other active or recurrent ocular disease (eg, iritis, uveitis, ocular infection, chronic moderate to severe blepharitis or severe dry eye, ocular seasonal allergies, diabetic retinopathy) in either eye that would interfere with the interpretation of the study data. However, ocular conditions of myopia, hyperopia, and strabismus (excluding cases where surgery is planned within the next 12 weeks) are allowed. 11. History or evidence of severe ocular trauma in either eye 12. Corneal or other ocular abnormalities (eg, bullous keratopathy, refractive surgery, corneal graft) that would preclude accurate readings with either Goldmann applanation tonometer or a hand-held tonometer. Note: A well-healed corneal scar or Haab’s striae will not exclude a patient. 13. Any ocular anterior segment (including glaucoma) surgery in the study eye(s) within 3 months prior to baseline 14. Patients who have had a cyclodestructive procedure 15. Known allergy or sensitivity to the study medication(s) or their components 16. Known allergy or contraindication to use of fluorescein 17. Contraindication to pupil dilation 18. Required chronic use of other ocular medications (post-screening visit) during the study. Note: Occasional use of artificial tear products is allowed but not within 24 hours prior to a scheduled visit through the week 12 visit. 19. Current enrollment in an investigational drug or device study or participation in such a study at or past the screening visit, or within 30 days prior to the baseline (day -1) visit 20. For patients with visual field test records, visual field loss that in the opinion of the investigator is functionally significant, or evidence of progressive visual field loss within the year prior to baseline (day -1) 21. Patient’s IOP was previously uncontrolled on bimatoprost or timolol monotherapy 22. Intermittent use of oral, intramuscular, or intravenous corticosteroids within 21 days prior to baseline or anticipated use within 21 days prior to a postbaseline study visit through the week 12 23. Use of topical ophthalmic corticosteroids from 2 months prior to the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and intraocular pressure (IOP)-lowering efficacy of once-daily bimatoprost 0.03% preservative-free (PF) ophthalmic solution compared with twice-daily timolol (0.5% or 0.25%, based on age group) ophthalmic solution for 12 weeks in paediatric patients with glaucoma.;Secondary Objective: N/A;Primary end point(s): Change from baseline (follow-up minus baseline) in the study eye IOP at week 12 (hour 2) is the primary efficacy variable. Note that a negative change from baseline indicates an IOP-lowering effect.;Timepoint(s) of evaluation of this end point: Week 12 (hour 2) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary variable is IOP response. A patient is considered to be an IOP responder if he/she demonstrates at least a 15% reduction from baseline study eye IOP at week 12 (hour 2). Patients who received escape medication for the study eye prior to the week 12 visit will be classified as non-responders.;Timepoint(s) of evaluation of this end point: Week 12 (hour 2) | — |
Countries
Brazil, Canada, France, Germany, Italy, Korea, Republic of, Philippines, Spain, Taiwan, United Kingdom, United States
Contacts
Public ContactAllergan Limited EU Regulatory Dept
Allergan Limited
Outcome results
None listed