E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
To evaluate the long-term safety of LUM 0.01% compared with LUM 0.03% administered once daily for 2 years in patients with glaucoma or ocular hypertension (OHT) |
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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 | 18.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10030043 |
E.1.2 | Term | 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 | 18.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10018304 |
E.1.2 | Term | 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 evaluate the long-term safety of LUM 0.01% compared with LUM 0.03% administered once daily for 2 years in patients with glaucoma or ocular hypertension (OHT) |
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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, at least 18 years of age and of legal age of consent. 2. Patient has either OHT, primary open-angle glaucoma (with elevated IOP as judged by the investigator), chronic angle-closure glaucoma with patent iridotomy/iridectomy, pseudoexfoliative glaucoma, or pigmentary glaucoma in each eye 3. Patient requires bilateral IOP-lowering therapy and his/her IOP is likely to be controlled on bimatoprost monotherapy 4. Baseline: A best-corrected visual acuity score equivalent to a Snellen acuity of 20/100 or better in each eye, using a logarithmic visual acuity chart for testing at 10 feet (3 meters) 5. Baseline: Negative urine pregnancy test for females of childbearing potential prior to randomization. 6. Written informed consent has been obtained prior to any study procedures 7. Patient is able and willing to follow study instructions and likely to complete all required visits 8. Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable (eg, written Data Protection consent [sites in European Union]). |
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E.4 | Principal exclusion criteria |
1. Uncontrolled systemic disease 2. Females who are pregnant, nursing, or planning a pregnancy or females of childbearing potential, not using a reliable method of contraception. A female is considered to be of childbearing potential unless she is without a uterus or is post-menopausal and has been amenorrheic for at least 12 consecutive months. 3. Patients with advanced ocular surface disease (eg, dry eye) or in whom the cornea is compromised. 4. Previous suspected adverse reaction to either PGA or to BAK exposure that has led to discontinuation of medication. 5. Known allergy or hypersensitivity to the study medication or its components 6. Allergy or contraindication to the use of topical fluorescein, lissamine green or any other diagnostic agent needed for study examination procedures 7. Active or recurrent ocular disease (eg, uveitis, ocular infections, chronic blepharitis, or moderate to severe dry eye), that in the opinion of the investigator would interfere with the interpretation of the study data. 8. Known chronic exposure to causes of ocular surface irritation (eg, smoke, chlorine) 9. History of recurrent ocular seasonal allergies within the past 2 years. 10. Qualification/baseline (day 1): active ocular surface findings (such as hyperaemia, irritation, dryness [including that associated with trabeculectomy blebs or drainage tubes, such as corneal dellen, etc], or staining) equal to mild or greater in either eye found on gross macroscopic hyperaemia or slit-lamp examination. Note: "Mild or greater" corresponds to a grade of at least +1 for all assessments of the ocular surface (see Attachment 12.1) except for the assessments of fluorescein staining of the cornea and lissamine green staining of the conjunctiva which use the Oxford Staining Scheme (Figure 2), where "mild or greater" corresponds to a grade of at least II (> 10 dots in any one of the three regions: cornea, nasal or temporal conjunctiva).11. Required chronic use of ocular medications during the study other than the study medication. Note: Intermittent use of artificial tear products is allowed, but not within 24 hours of a scheduled visit. Intermittent use of ocular decongestants or antihistamines is allowed, but not within 2 weeks of a scheduled visit 12. Corneal or other ocular abnormalities that would preclude accurate readings with an applanation tonometer 13. Patient’s IOP was previously uncontrolled on bimatoprost monotherapy 14. History of severe ocular trauma 15. History (within 3 months prior to qualification/baseline [day 1]) of ocular laser, intraocular, filtering or refractive surgery or planned ocular surgery of any kind at entry (qualification/baseline) 16. 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 qualification/baseline (day 1) (Note-Results of two reliable visual field (VF) examinations are required for assessment of eligibility prior to randomization [see Section 8.2.2]. Both VF examinations should use the protocol-required testing method [see Attachment 12.1]) 17. Contraindication to pupil dilation 18. Anticipated wearing of contact lenses during the study (after signing informed consent, use of soft lenses should be discontinued at least 24 hours prior to qualification/baseline [day 1], and use of rigid gas permeable [RGP] or hard contact lenses should be discontinued at least 1 week prior to qualification/baseline [day 1]) 19. Current enrollment in an investigational drug or device study or participation in such a study within 30 days prior to qualification/baseline (day 1) 20. Patient has a condition or is in a situation that, in the investigator’s opinion, may put the patient at a significant risk, may confound study results, or may interfere significantly with the patient’s participation in the study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Reports of one or more treatment-related adverse events associated with the ocular surface will be the primary variable. The proportion of patients reporting treatment-related ocular surface adverse events over the 2-year course of the study (Day1, Month 2, Month 6, Month 12, Month 18, Month 24) in each treatment group will be calculated. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Adverse events will be monitored throughout the study. Adverse events over the 2-year course of the study (Day1, Month 2, Month 6, Month 12, Month 18, Month 24) in each treatment group will be calculated. |
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E.5.2 | Secondary end point(s) |
Reports of one or more treatment-related adverse events associated with the ocular surface excluding those with a MedDRA preferred term of “conjunctival hyperaemia” will be the secondary variable. The proportion of patients reporting these adverse events in each treatment group over the 2-year course of the study (Day1, Month 2, Month 6, Month 12, Month 18, Month 24) will be calculated.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Adverse events will be monitored throughout the study. The proportion of patients reporting these adverse events in each treatment group over the 2-year course of the study (Day1, Month 2, Month 6, Month 12, Month 18, Month 24) will be calculated.
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 50 |
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 |
Belgium |
Czech Republic |
France |
Germany |
Hungary |
Israel |
Italy |
Poland |
Spain |
United Kingdom |
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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 | 5 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 7 |
E.8.9.2 | In all countries concerned by the trial days | 0 |