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

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Pharma Advanced Research Company Limited

Criteria

Inclusion Criteria:

• Men and women aged ≥18 years

• Willing to participate and giving written informed consent

• Willing to commit to study medication-dosing, study visits and follow-up visits to complete evaluation

• Eligible to receive Latanoprost once a daily as monotherapy for treatment of glaucoma

Exclusion Criteria:

• History of allergic hypersensitivity or poor tolerance to latanoprost

• History of Substance abuse or addiction (alcohol drugs) in the past 3 years

• History of chronic use of concomitant medications in neurologic or psychiatric illness that would affect assessment of safety and effectiveness of the study medication

• Any abnormality preventing IOP measurement