NCT02537015

An Open-label Extension Study to Evaluate the Safety of the 13 mg Bimatoprost Ocular Insert

An Open-label Extension (OLE 2) Study to Evaluate the Safety of the 13 mg Bimatoprost Ocular Insert in Subjects With Open-angle Glaucoma or Ocular Hypertension Who Have Completed Study FSV5-004

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: ForSight Vision5, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study evaluated the long-term (9-months) safety of the Bimatoprost Ocular Insert in participants with Glaucoma or Ocular Hypertension who completed study FSV5-004. All the participants received Bimatoprost Ocular Insert and wore it for approximately 3 months (12 weeks), then had that Insert removed and a new Insert placed for another 26 weeks (approximately 6 months).

Conditions

• Primary Open-Angle Glaucoma
• Ocular Hypertension

Interventions

Type	Name	Description
DRUG	Bimatoprost	Bimatoprost Ocular Insert in each eye used continuously for 12 weeks, then replaced with a new Bimatoprost Ocular Insert in each eye used continuously for another 26 weeks.

Timeline

• Start date: 2015-08-10
• Primary completion: 2016-08-11
• Completion: 2016-08-11
• First posted: 2015-09-01
• Last updated: 2019-04-02
• Results posted: 2019-02-26

Locations

9 sites across 1 country: United States