Safety and Efficacy of Bimatoprost Solution in Treating Eyelash Loss or Hypotrichosis in Children

Allergan

Status and phase: Completed; Phase 4

Conditions: Eyelash Hypotrichosis; Alopecia Areata

Treatments: Drug: bimatoprost ophthalmic solution 0.03%; Drug: Vehicle Sterile Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT01023841

192024-040

Details and patient eligibility

About

This study will evaluate the safety and efficacy of bimatoprost solution 0.03% once daily application to the upper eyelid margins compared with vehicle in treating eyelash loss or hypotrichosis (inadequate or not enough eyelashes) in children.

Enrollment: 71 patients

Sex: All

Ages: 5 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children who have inadequate eyelashes or have lost their eyelashes as a result of chemotherapy treatment, who completed their chemotherapy (intensive treatment) at least 4 weeks before starting the study, are considered to be at low risk for relapse of their cancer, and are well enough to complete the study
• Children who have minimal to moderate inadequate eyelashes due to alopecia areata
• Adolescents between the ages of 15-17 years who have minimal to marked inadequate eyelashes

Exclusion criteria

• Any eye disease or abnormality, eye surgery, permanent eyeliner, eyelash implants.
• Semi-permanent eyelash tint, dye or eyelash extension application within 3 months
• Use of over the counter eyelash growth products within 6 months.
• Use of prescription eyelash growth products (eg, Latisse®)
• Any eye condition that would prevent required ophthalmology exams

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

71 participants in 2 patient groups, including a placebo group

bimatoprost ophthalmic solution 0.03%

Active Comparator group

Description:

One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.

Treatment:

Drug: bimatoprost ophthalmic solution 0.03%

Vehicle Sterile Solution

Placebo Comparator group

Description:

One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.

Treatment:

Drug: Vehicle Sterile Solution