Study of Bimatoprost Solution in Increasing Eyelash Prominence in African Americans With Eyelash Hypotrichosis

Allergan

Status and phase: Completed; Phase 4

Conditions: Hypotrichosis

Treatments: Drug: vehicle sterile solution (placebo); Drug: bimatoprost ophthalmic 0.03% solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT00958035

192024-039

Details and patient eligibility

About

This study will evaluate the safety and efficacy of bimatoprost solution 0.03% once daily to the upper eyelid margins (where the eyelashes meet the skin) compared with vehicle in increasing overall eyelash prominence in self-identified African American/ethnic black subjects exhibiting hypotrichosis of the eyelashes (inadequate or not enough eyelashes).

Enrollment: 89 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• African American/ethnic black
• Adults at least 18 years of age
• Eyelash prominence assessment of minimal or moderate

Exclusion criteria

• Subjects with uneven lashes or longer on one side than the other
• Any eye disease or abnormality
• Eye surgery
• Severe hyperpigmentation around the eye
• Eyelash implants
• Eyelash extension application
• Any use of eyelash growth products within 6 months
• Any use of prescription eyelash growth products
• Treatments that may affect hair growth
• Requiring eye drop medications for glaucoma

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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89 participants in 2 patient groups, including a placebo group

LATISSE®

Experimental group

Description:

bimatoprost ophthalmic 0.03% solution

Treatment:

Drug: bimatoprost ophthalmic 0.03% solution

Placebo

Placebo Comparator group

Description:

vehicle sterile solution

Treatment:

Drug: vehicle sterile solution (placebo)