E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
Inadequate or not enough eyelashes |
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E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10021127 |
E.1.2 | Term | Hypotrichosis of eyelid |
E.1.2 | System Organ Class | 100000004858 |
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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 safety and efficacy of bimatoprost solution 0.03% single dose vial configuration compared with marketed bimatoprost solution 0.03% in the bottle/applicator configuration and vehicle in increasing overall eyelash prominence following once daily, bilateral, dermal administration to the upper eyelid margins of patients with idiopathic eyelash hypotrichosis. |
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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 2. Patient has eyelash hypotrichosis as measured by a GEA score of 1 or 2 at screening and baseline 5. Visual acuity score equivalent to a Snellen acuity of 20/100 or better in each eye, using a standardized logarithmic visual acuity chart for testing at 10 feet and wearing any prescribed spectacles or contact lens 6. Standardized eyelash photographs during the screening period of acceptable quality for image analysis as verified by Canfield Scientific, Inc (Fairfield, NJ) 7. Ability to follow study instructions and likely to complete all required visits 8. For females of childbearing potential, a negative pregnancy test result must be confirmed prior to receiving study treatment on day 1. A woman is considered NOT to be of childbearing potential if she either is postmenopausal with at least 12 consecutive months of amenorrhea or has no uterus. 9. Patient has the ability to follow study instructions and complete study assessment tools, (eg, ESQ-9) without any assistance or alteration to the assessment tool |
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E.4 | Principal exclusion criteria |
1. Uncontrolled systemic disease 2. Significant asymmetry of eyelashes of the right and left eyelid, based on the opinion of the investigator 3. Any clinically significant condition or abnormality of the lashes, ocular surface, periocular skin, or lacrimal duct system 4. Any damage to the eyelid area (eg, scarring) that may prevent the growth of eyelashes 5. Known or suspected trichotillomania 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 (eg, glaucoma, uveitis, ocular infections, chronic blepharitis, or severe dry eye). However, myopia, 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 screening or any anticipated need for ocular surgery for the duration of the study 10. Patients unwilling or unable to remove contact lenses prior to application of study treatment in the evening and keep lenses out for at least 15 minutes following application 11. Any permanent eyeliner on the upper eyelid margin 12. Current eyelash implants of any kind, or anticipated use of false eyelashes during the study 13. Any eyelash tint or dye application within 2 months of baseline 14. Any eyelash extension application within 3 months of baseline 15. Any use of eyelash growth products within 6 months of baseline 16. Any history of use of prescription eyelash growth products (eg, LATISSE) 17. Concurrent treatment with any prostaglandin or prostamide (ocular or systemic) 18. Treatments that may affect hair growth (eg, minoxidil, cancer chemotherapeutic agents, etc) within 6 months prior to baseline, or anticipated use of these treatments during the study 19. Any patients requiring IOP-lowering eye medication or requiring prescription medications for dry eye at baseline, or anticipated use of these treatments during the study 20. Patients with macular edema or those who are aphakic, pseudophakic with a torn posterior lens capsule, or patients having known risk factors for macular edema 21. Known allergy or sensitivity to the study treatment(s) or its components or the eye makeup remover provided in the study 22. Females who are pregnant, nursing, or planning a pregnancy 23. Females of childbearing potential, not using a reliable means of contraception as determined between the patient and investigator 24. Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study and previous enrollment in any Allergan sponsored bimatoprost studies 25. Investigational site staff and/or their relatives 26. Patient has a condition or is in a situation which 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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
The proportion of patients with at least a 1-grade increase (improvement) from baseline in the GEA score at month 4. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Change from baseline at month 4 in eyelash length as measured using DIA.
Change from baseline at month 4 in eyelash thickness/fullness as measured using DIA.
Change from baseline at month 4 in eyelash darkness as measured using DIA.
Proportion of patients who report “very satisfied/satisfied” or "neutral/unsatisfied/very unsatisfied” in Item #3 from ESQ-9 at month 4. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 4 |
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 | 6 |
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 |
Russian Federation |
Sweden |
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 | 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 |