EUCTR2012-003007-35-GB进行中（未招募）1 期
Bimatoprost in the Treatment of Eyelash Hypotrichosis
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 464
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 434
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •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
研究者
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