NCT01298700

Long-Term Safety of Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension

A 2-year, Multicenter, Double-masked, Randomized, Parallel Study of the Safety of LUMIGAN® 0.1 mg/mL Compared With LUMIGAN® 0.3 mg/mL in Patients With Glaucoma or Ocular Hypertension

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 806 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the long-term safety of bimatoprost 0.01% ophthalmic solution compared with bimatoprost 0.03% ophthalmic solution in patients with glaucoma or ocular hypertension.

Conditions

• Glaucoma
• Ocular Hypertension

Interventions

Type	Name	Description
DRUG	bimatoprost 0.01% ophthalmic solution	One drop of bimatoprost 0.01% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.
DRUG	bimatoprost 0.03% ophthalmic solution	One drop of bimatoprost 0.03% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.

Timeline

• Start date: 2011-05-31
• Primary completion: 2016-12-06
• Completion: 2016-12-06
• First posted: 2011-02-18
• Last updated: 2018-09-17
• Results posted: 2018-09-17

Locations

50 sites across 10 countries: Belgium, Czechia, France, Germany, Hungary, Israel, Italy, Poland, Spain, United Kingdom