NCT00945958

Evaluation of Safety of SPARC0913 in Open Angle Glaucoma or Ocular Hypertension

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 161 (actual)
• Sponsor: Sun Pharma Advanced Research Company Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the long-term safety of SPARC0913. A multicenter, open label, non-randomized, uncontrolled, single group assignment, safety study of subjects with primary open angle glaucoma or ocular hypertension is planned. Subjects will receive study medication for a period of 24-weeks.

Detailed description

This is a multicenter, open label, non-randomized, single-arm, extension safety study to evaluate the long-term safety of SPARC0913. Subjects who completed the prior evaluator-masked clinical non-inferiority Study participated in the current study.

Conditions

• Open Angle Glaucoma
• Ocular Hypertension

Interventions

Type	Name	Description
DRUG	SPARC0913	One drop of SPARC0913 in affected eye once daily for 24 weeks

Timeline

• Start date: 2010-11-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2009-07-24
• Last updated: 2021-03-09
• Results posted: 2016-05-05

Locations

1 site across 1 country: United States