E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Hypotrichosis of the eyelashes |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10021126 |
E.1.2 | Term | Hypotrichosis |
|
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 and efficacy of bimatoprost 0.03% solution once daily bilateral application to the upper eyelid margins compared with vehicle in increasing overall eyelash prominence in subjects exhibiting hypotrichosis of the eyelashes from varied etiologies. |
|
E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or female subjects at least 18 years of age
2. For post chemotherapy subjects, the following criteria will be verified by the investigator, including using the subject's prior medical history obtained from the subject's attending oncologist: a. Subject reports chemotherapy induced eyelash hypotrichosis b. Treated for solid tumor type stage 1 or stage 2 cancer with a curative intent, i.e. received standard adjuvant therapy for breast or colorectal cancer, or received front-line therapy for diffuse larger-cell lymphoma or Hodgkin's lymphoma. c. All side effects and serious side effects related to chemotherapy treatment are resolved with the exception of hair loss, e.g. hematology and liver function test results are within the range acceptable to the oncologist and investigator; any other chemotherapy induced effects such as oral mucositis, eye irritation, or skin rash or discoloration have resolved. d. Completed their course of chemotherapy treatment at least 4 weeks but no more than 12 weeks prior to baseline. e. No evidence of metastases, and not anticipated to receive further chemotherapy during the course of the study f. ECOG score of 0 or 1 g. Anticipated to be well enough to complete the study
3. Written informed consent has been obtained prior to any study-related procedures
4. Written Authorization for Use and Release of Health and Research Study Information (US sites only) or Data Protection Consent (European sites only) has been obtained.
5. A score of 1 or 2 on the Glibal Eyelash Assessment (GEA)
6. A score of 1 or 2 on each of 3 items (16, 19, and 18) on the PRO questionnaire
7. 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
8. Intraocular pressure (IOP) ≤ 20 mm Hg in each eye
9. Female subjects of childbearing potential must have a negative urine pregnancy test at Day 1 prior to receiving study medication. A woman is considered NOT to be of childbearing potential if she either is post menopausal with at least 12 consecutive months of amenorrhea or has no uterus.
10. Ability to follow study instructions and willingness to complete all required procedures and visits.
|
|
E.4 | Principal exclusion criteria |
1. Any uncontrolled systemic disease
2. Subjects with unequal right and left GEA scores
3. Subjects with any known disease or abnormality of the lids, lashes, ocular surface, or lacrimal duct system
4. Subjects with alopecia areata or scarring alopecia of the eyelid including lid tumors, herpes zoster, and other eyelid skin scarring diseases
5. Subjects with known or suspected trichotilomania disorder
6. Any ocular pathology in either eye that may interfere with the ability to obtain accurate IOP readings
7. Contraindications to pupil dilation
8. Active ocular disease (e.g. glaucoma, uveitis, ocular infections, ocular tumor, severe dry eye, or chronic blepharitis); myopia, hyperopia, presbyopia, strabismus, and cataracts are allowed provided other study criteria are met
9. Any ocular or eyelid surgery (including laser, refractive, intraocular filtering surgery, blepharoplasty) during the 3 months prior to baseline or any anticipated need for ocular surgery for the duration of the study
10. Subjects unwilling or unable to remove contact lenses prior to study medication application in the evening and keep lenses out for at least 30 minutes following application
11. Any permanent eyeliner or eyelash implants of any kind
12. Any semi-permanent eyelash tint, dry, or eyelash extension application within 3 months prior to baseline; daily use of removable eyeliner and mascara is allowed provided other study criteria are met
13. Any use of over-the-counter eyelash growth products within 6 months prior to baseline
14. Any use of prescription eyelash growth products (i.e. LATISSE™ in US)
15. Treatments that may affect hair growth (e.g., minoxidil, Propecia®, etc) within 6 months prior to baseline, except for prior chemotherapy in the post chemotherapy subject population.
16. Any required use of IOP-lowering eye drops such as prostaglandin or prostamide, or prescription medications for dry eye at baseline, or anticipated use of these treatments during the study; OTC artificial tears or lubricants are allowed
17. Known allergy or sensitivity to the study medication, its components, or eye make-up remover used in the study 18. Subjects with mascular edema or those who are aphakic, pseudophakic with a torn posterior lens capsule, or subjects having known risk factors for macular edema
19. Females who are pregnant, nursing, or planning a pregnancy during the study or who are of childbearing potential and not using a reliable method of contraception
20. Current enrolment in an investigational drug or device study or participation in such a study within 30 days prior to baseline and previous enrolment in any Allergan sponsored bimatoprost clinical studies
21. Investigational site staff and/or their relatives
22. Subject has a condition or is in a situation which, in the investigator’s opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subjects participation in the study
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Bimatoprost 0.03% solution and vehicle are equally effective in increasing eyelash prominence as measured by the proportion of treatment responders at month 4, a composite endpoint defined by 1) at lease a 1-grade improvement from baseline in the 4-point GEA scale and 2) at least a 3-point improvement from baseline in the total score for domain 2 of a PRO questionnaire |
|
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 | 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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
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 | 9 |
E.8.5 | The trial involves multiple Member States | No |
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 | Information not present in EudraCT |
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 |
|
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
|
The end of the trial will be the last subject last visit. |
|
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 | 6 |
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 | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |