NCT02143843

An Open-Label Extension Study to Evaluate the Safety of the ForSight VISION5 Product

An Open-Label Extension (OLE) Study to Evaluate the Safety of the ForSight VISION5 Product in Subjects With Open-Angle Glaucoma or Ocular Hypertension Who Have Completed Study FSV5-002

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: ForSight Vision5, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the long-term (13-months) safety of the Bimatoprost Ocular Insert in participants with Glaucoma or Ocular Hypertension who completed study FSV5-002. All participants received Bimatoprost Ocular Insert and wore it for approximately 7 months, then had the Insert removed and a new insert placed for another 6 months.

Conditions

• Primary Open-Angle Glaucoma
• Ocular Hypertension

Interventions

Type	Name	Description
DRUG	Bimatoprost	Bimatoprost Ocular Insert used continuously for 7 months, then replaced with a new Bimatoprost Ocular Insert and used continuously for another 6 months.

Timeline

• Start date: 2014-06-05
• Primary completion: 2015-12-31
• Completion: 2016-01-31
• First posted: 2014-05-21
• Last updated: 2019-02-26
• Results posted: 2019-02-26

Locations

10 sites across 1 country: United States