NCT02444767

Bimatoprost Ocular Insert Pharmacokinetic Study

A PK Study to Assess the Relative Systemic Exposure to Bimatoprost and Bimatoprost Acid After Administration of a Single 13 mg Bimatoprost Ocular Insert for 1 Week in Medically Stable Adult Subjects With or Without Open-Angle Glaucoma or Ocular Hypertension

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: ForSight Vision5, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The Bimatoprost Ocular Insert is intended to provide sustained delivery of bimatoprost to the ocular surface to lower the intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. This study will evaluate the pharmacokinetic aspects of the Bimatoprost Ocular Insert in healthy (non-glaucoma) subjects.

Detailed description

This study is designed to provide pharmacokinetic (PK) data with respect to the relative systemic exposure to bimatoprost and bimatoprost acid after administration of a single 13 mg Bimatoprost Ocular Insert for 1 week in medically stable adult subjects with or without primary open angle glaucoma (POAG) or ocular hypertension (OHT).

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	13mg Bimatoprost Ocular Insert	13mg Bimatoprost Ocular Insert in each eye.

Timeline

• Start date: 2015-03-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2015-05-14
• Last updated: 2015-05-14

Locations

1 site across 1 country: United States