Safety and Efficacy of Bimatoprost Ophthalmic Solution in Increasing Eyelash Prominence

Allergan

Status and phase: Completed; Phase 2

Conditions: Eyelash Hypotrichosis

Treatments: Drug: bimatoprost ophthalmic solution 0.015%; Drug: bimatoprost ophthalmic solution 0.03%; Drug: bimatoprost ophthalmic solution 0.005%

Study type: Interventional

Funder types: Industry

Identifiers

NCT01064882

192024-051

Details and patient eligibility

About

This study will evaluate the safety and efficacy of bimatoprost ophthalmic solution 0.005% or 0.015% compared with bimatoprost ophthalmic solution 0.03% once-daily application to the upper eyelid margins in increasing eyelash prominence

Enrollment: 104 patients

Sex: Female

Ages: 30 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female Caucasians between 30 and 55 years of age, with hypotrichosis (inadequate or not enough) of the eyelashes
• Eyelash prominence assessment of minimal or moderate

Exclusion criteria

• Any eye disease or abnormality
• Any permanent eyeliner or eyelash implants of any kind
• Any ocular surgery, semi-permanent eyelash tint, or eyelash extension application during the 3 months prior to study entry
• Any use of prescription eyelash growth products
• Any use of over the counter eyelash growth products during the 6 months prior to baseline
• Any use of treatments that may affect hair growth during the 6 months prior to baseline

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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104 participants in 3 patient groups

bimatoprost ophthalmic solution 0.005%

Experimental group

Description:

bimatoprost ophthalmic sterile solution 0.005%

Treatment:

Drug: bimatoprost ophthalmic solution 0.005%

bimatoprost ophthalmic solution 0.015%

Experimental group

Description:

bimatoprost ophthalmic sterile solution 0.015%

Treatment:

Drug: bimatoprost ophthalmic solution 0.015%

bimatoprost ophthalmic solution 0.03%

Active Comparator group

Description:

bimatoprost ophthalmic solution 0.03%

Treatment:

Drug: bimatoprost ophthalmic solution 0.03%