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

Completed · Phase 3

Conditions studied: Open Angle Glaucoma, Ocular Hypertension

In brief

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.

Key facts

Study ID

NCT00945958

Run by

Sun Pharma Advanced Research Company Limited

People needed

161

Starts

2010-11-01

Expected to finish

2012-06-01

Last updated by the study team

2021-03-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• SPARC study site — High Point, North Carolina, United States

Full record on ClinicalTrials.gov

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