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

Allergan

Status and phase: Completed; Phase 3

Conditions: Hypotrichosis

Treatments: Drug: Bimatoprost 0.03% solution; Drug: Vehicle solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT00907426

192024-038

Details and patient eligibility

About

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.

Enrollment: 368 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects who have inadequate eyelashes due to natural causes and are not satisfied with their eyelash appearance.
• For the post-chemotherapy population: subjects who have inadequate eyelashes following a complete course of chemotherapy treatment and are not satisfied with their eyelash appearance, are considered free of cancer and are well enough to complete the study.

Exclusion criteria

• Subjects with unequal right and left eyelashes, any eye disease or abnormality, eye surgery, permanent eyeliner, eyelash implants, eyelash extension application.
• Any use of over the counter or prescription use eyelash growth products.
• Subjects requiring eye drop medications for glaucoma.
• Females who are pregnant, nursing or planning a pregnancy during the study or who are of childbearing potential and not using a reliable method of contraception.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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368 participants in 3 patient groups

Bimatoprost 0.03% Followed by Bimatoprost 0.03%

Experimental group

Description:

Treatment period one (0-6 months), 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). For treatment period two (6-12 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin.

Treatment:

Drug: Bimatoprost 0.03% solution

Bimatoprost 0.03% Followed by Vehicle

Other group

Description:

Treatment period one (0-6 months), 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). For treatment period two (6-12 months), once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin.

Treatment:

Drug: Vehicle solution

Drug: Bimatoprost 0.03% solution

Vehicle Followed by Bimatoprost 0.03%

Other group

Description:

Treatment period one (0-6 months), 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). For treatment period two (6-12 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin.

Treatment:

Drug: Vehicle solution

Drug: Bimatoprost 0.03% solution