Bimatoprost in the Treatment of Eyelash Hypotrichosis

Allergan

Status and phase: Completed; Phase 3

Conditions: Idiopathic Eyelash Hypotrichosis

Treatments: Drug: vehicle of bimatoprost formulation A solution; Drug: vehicle of bimatoprost solution 0.03 %; Drug: bimatoprost formulation A solution; Drug: bimatoprost solution 0.03 %

Study type: Interventional

Funder types: Industry

Identifiers

NCT01698554

192024-046

2012-003007-35 (EudraCT Number)

Details and patient eligibility

About

This study will evaluate the safety and efficacy of bimatoprost solution formulation A compared with bimatoprost solution 0.03% (LATISSE®) and vehicle in the treatment of eyelash hypotrichosis (inadequate eyelashes).

Enrollment: 464 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

-Male and female adult patients with eyelash hypotrichosis (inadequate eyelash growth).

Exclusion criteria

• Damage to eyelid area (scarring) that may prevent growth of eyelashes
• Active eye diseases (glaucoma, uveitis, eye infections, chronic blepharitis or severe dry eye)
• Eye or eyelid surgery (including laser, refractive, intraocular filtering surgery, blepharoplasty) during the 3 months prior to screening
• Current eyelash implants of any kind
• Eyelash tint or dye application within 2 months of baseline
• Eyelash extensions application within 3 months of baseline
• Use of eyelash growth products within 6 months of baseline
• Treatments that may affect hair growth (minoxidil, cancer chemotherapeutic agents, etc) within 6 months prior to baseline.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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464 participants in 4 patient groups, including a placebo group

bimatoprost formulation A solution

Experimental group

Description:

Bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.

Treatment:

Drug: bimatoprost formulation A solution

bimatoprost solution 0.03 %

Active Comparator group

Description:

Bimatoprost solution 0.03 % (LATISSE®) multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.

Treatment:

Drug: bimatoprost solution 0.03 %

vehicle of bimatoprost formulation A solution

Placebo Comparator group

Description:

Vehicle of bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.

Treatment:

Drug: vehicle of bimatoprost formulation A solution

vehicle of bimatoprost solution 0.03 %

Placebo Comparator group

Description:

Vehicle of bimatoprost solution 0.03 % multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.

Treatment:

Drug: vehicle of bimatoprost solution 0.03 %