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) MedDRA version: 19.0 Level: PT Classification code 10030043 Term: Ocular hypertension System Organ Class: 10015919 - Eye disorders MedDRA version: 19.0 Level: PT Classification code 10018304 Term: Glaucoma System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Trade Name: LUMIGAN 0.1mg/ml
Product Name: Not Applicable
Product Code: Not Applicable
Pharmaceutical Form: Eye drops, solution
INN or Proposed INN: BIMATOPROST
CAS Number: 155206-00-1
Concentration u
Sponsors
Allergan Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female, at least 18 years of age and of legal age of consent. 2. Patient has either OHT, chronic 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]). Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 392 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 392
Exclusion criteria
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. Curr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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);Secondary Objective: Not applicable;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.;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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. ;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. | — |
Countries
Belgium, Czech Republic, France, Germany, Hungary, Israel, Italy, Poland, Spain, United Kingdom
Contacts
Public ContactAllergan Limited EU Regulatory Dept
Allergan Limited
Outcome results
None listed