Treatment of subjects with inadequate or not enough eyelashes

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 454

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
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

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