Safety and Efficacy Study of Bimatoprost in Japanese Patients With Eyelash Hypotrichosis

Allergan

Status and phase: Completed; Phase 3

Conditions: Eyelash Hypotrichosis

Treatments: Drug: bimatoprost solution 0.03%; Drug: bimatoprost vehicle solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT01391273

192024-059

Details and patient eligibility

About

This study will evaluate the safety and efficacy of bimatoprost solution 0.03% compared with vehicle in Japanese adults with hypotrichosis of the eyelashes.

Enrollment: 173 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have inadequate eyelashes

Exclusion criteria

• Any disease/infection/abnormality of the eye or area around the eye
• Any ocular surgery within 3 months or anticipated need for ocular surgery during the study
• Any permanent eyeliner or implants of any kind or anticipated use of false eyelashes
• Any semi-permanent eyelash tint, dye, curl or eyelash extension application within 3 months
• Use of any over-the-counter eyelash growth product within 6 months or any use of prescription eyelash growth products
• Use of treatments which may affect hair growth (eg, minoxidil, chemotherapy) within 6 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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173 participants in 2 patient groups, including a placebo group

bimatoprost solution 0.03%

Experimental group

Description:

One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.

Treatment:

Drug: bimatoprost solution 0.03%

bimatoprost vehicle solution

Placebo Comparator group

Description:

One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.

Treatment:

Drug: bimatoprost vehicle solution