E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Glaucoma or Ocular Hypertension |
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E.1.1.1 | Medical condition in easily understood language |
Ocular hypertension (high pressure in the eye) or glaucoma (an eye disease in which ocular hypertension may cause vision loss). |
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E.1.1.2 | Therapeutic area | Diseases [C] - Eye Diseases [C11] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10008833 |
E.1.2 | Term | Chronic angle-closure glaucoma |
E.1.2 | System Organ Class | 10015919 - Eye disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | HLGT |
E.1.2 | Classification code | 10018307 |
E.1.2 | Term | Glaucoma and ocular hypertension |
E.1.2 | System Organ Class | 10015919 - Eye disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10009034 |
E.1.2 | Term | Chronic open angle glaucoma |
E.1.2 | System Organ Class | 10015919 - Eye disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To compare the efficacy and safety of bimatoprost 0.03%/ timolol 0.5% PF ophthalmic solution with GANFORT once-daily use for 12 weeks in patients with glaucoma or ocular hypertension (OHT).
To show that bimatoprost 0.03%/timolol 0.5% PF ophthalmic solution has an acceptable safety profile. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or female, 18 years of age or older and with legal age of consent.
2. Written informed consent has been obtained.
3. Written data protection consent has been obtained.
4. Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable.
5. Good general health, as determined by the investigator from medical history, physical examination finding, fasting blood analysis (hematology, blood chemistry), and urinalysis, that are within reference range or acceptable to the investigator. Patients may have laboratory tests repeated once for re-screening at the discretion of the investigator.
6. Baseline: A negative urine pregnancy test result for females of childbearing potential. A female is considered to be of non-childbearing potential if she is postmenopausal (with no menses for 12 consecutive months) or without a uterus.
7. Patient is able and willing to follow study instructions and likely to complete all required visits.
8. Patient has ocular hypertension, chronic open-angle glaucoma, chronic-angle closure glaucoma with patent iridotomy/iridectomy, pseudoexfoliative glaucoma, or pigmentary glaucoma in both eyes.
9. Patient can go without IOP-lowering therapy for 4 days to 4 weeks, without significant risk to the patient.
10. Patient requires bilateral IOP-lowering therapy
11. Hour 0 of screening: Patient has been on current medication for at least 1 month or is treatment naive.
12. Hour 0 and hour 2 of screening: Approximately 12 to 14 hours after the last installation of any current medication, patient had been on treatment considered to be ineffective (IOP > 18 mm Hg in at least 1 eye) for at least 1 month OR treatment naive (IOP > 24 mm Hg in at least 1 eye). Qualifying hour 0 and hour 2 IOPs must have been from the same eye.
13. Hour 0 of baseline: best-corrected visual acuity (BCVA) score equivalent to a Snellen acuity of 20/100 or better in each eye, using a logarithmic visual acuity chart.
14. Hour 0 of baseline: IOP of ≥ 22 mm Hg and ≤ 30 mm Hg in each eye and asymmetry of IOP not greater than 3 mm Hg between the eyes |
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E.4 | Principal exclusion criteria |
1. Uncontrolled systemic disease.
2. Female patients who are pregnant, nursing, or planning a pregnancy or who are of childbearing potential and not using a reliable means of contraception throughout the study.
3. Clinically relevant low or high blood pressure or pulse rate for age as determined by the investigator.
4. Patient has a condition or is in a situation that, in the investigator’s opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient’s participation in the study.
5. Contraindications to beta-adrenoceptor antagonist therapy such as chronic obstructive pulmonary disease, bronchial asthma, sinus bradycardia, second and third degree atrioventricular block, overt cardiac failure or cardiogenic shock or uncontrolled congestive heart failure.
6. Known allergy or contraindication to use of fluorescein.
7. Known allergy or sensitivity to the study medications or their components.
8. Intermittent use of oral, intramuscular, or intravenous corticosteroids within 21 days prior to baseline or anticipated use within 21 days prior to a follow-up study visit, or topical ophthalmic corticosteroids from 2 months prior to the screening visit through the final study visit.
9. 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.
10. Corneal or other ocular abnormalities that would preclude accurate readings with an applanation tonometer (eg, refractive surgery, corneal graft, moderate to severe endothelial corneal dystrophy).
11. Contraindication to pupil dilation.
12. Central corneal thickness of greater than 600 micrometers or less than 500 micrometers in either eye at screening.
13. Introduction or anticipated alteration of existing chronic systemic medications (topical or injection) that may have a substantial effect on IOP (eg, systemic betablockers) from 2 months prior to screening visit through the final study visit.
14. Active or recurrent ocular disease (eg, uveitis, ocular infection, chronic moderate to severe blepharitis or severe dry eye, ocular seasonal allergies) that would interfere with the interpretation of the study data in either eye. NOTE: patients with chronic mild blepharitis, cataract, age-related macular degeneration, or a background diabetic retinopathy can be enrolled at the discretion of the investigator.
15. History (within 6 months prior to baseline) of any ocular anterior segment laser or other intraocular surgery in either eye.
16. History or evidence of severe ocular trauma in either eye.
17. History of ocular neoplasia, uveitis, or herpetic ocular diseases.
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.
19. 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).
20. In either eye, anticipated wearing of contact lenses during the study (use of soft lenses should be discontinued at least 24 hours prior to baseline, and use of rigid gas permeable or hard contact lenses should be discontinued at least 1 week prior to baseline).
21. Patient’s IOP was previously uncontrolled on bimatoprost monotherapy.
22. Hour 0 of baseline : Ocular surface findings (eg, hyperemia or irritation equal to +0.5 [trace] or greater) in either eye. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The IOP-lowering effect of bimatoprost 0.03%/timolol 0.5% PF
ophthalmic solution is non inferior to GANFORT with respect to change from baseline (follow-up minus baseline) in worse eye IOP at each hour evaluated (hours 0, 2 and 8) at week 12 in the PP population. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Change from baseline (follow-up minus time-matched baseline) in worse
eye IOP at each hour evaluated (hours 0, 2 and 8) at week 12. |
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E.5.2 | Secondary end point(s) |
The IOP-lowering effect of bimatoprost 0.03%/timolol 0.5% PF
ophthalmic solution is equivalent to GANFORT with respect to change
from baseline (follow-up minus baseline) in worse eye IOP at each hour
evaluated (hours 0, 2 and 8) at week 12. This will be assessed in the ITT
population. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Change from baseline (follow up minus baseline) in worse eye IOP at
each hour evaluated (hours 0, 2 and 8) at week 12. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 13 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 33 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Australia |
Czech Republic |
Germany |
Hungary |
Israel |
Russian Federation |
Spain |
United Kingdom |
United States |
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E.8.7 | Trial has a data monitoring committee | No |
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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |