NCT00907426

Safety and Efficacy Study of Bimatoprost to Treat Hypotrichosis of the Eyelashes After Application to the Eyelid Margin

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 368 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This one-year study evaluates the long-term safety and effectiveness of bimatoprost solution application to the eyelid margin (where the eyelashes meet the skin) to treat hypotrichosis of the eyelashes (inadequate or not enough eyelashes). There will be two different types of subjects participating in the study 1)those with inadequate eyelashes due to natural causes or 2) those with inadequate eyelashes following a complete course of chemotherapy treatment. There will be two treatment periods of six months each. Subjects will receive either the study medication or vehicle in either of the two treatment periods.

Conditions

• Hypotrichosis

Interventions

Type	Name	Description
DRUG	Bimatoprost 0.03% solution	Once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin).
DRUG	Vehicle solution	Once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin).

Timeline

• Start date: 2009-08-01
• Primary completion: 2010-11-01
• Completion: 2011-05-01
• First posted: 2009-05-22
• Last updated: 2012-09-19
• Results posted: 2012-09-19

Locations

2 sites across 2 countries: United States, United Kingdom