drugset / Trial / NCT00947661

Efficacy and Safety of SPARC0912 and Reference0912 in Open Angle Glaucoma or Ocular Hypertension

NCT00947661 ↗

Phase 3 Completed 578 enrolled Sun Pharma Advanced Research Company Limited
RandomizedParallel-groupDouble-blindTreatment

Summary

A single-blind , 12-week, parallel group clinical study is planned to evaluate the efficacy and safety of SPARC0912 and Reference0912. SPARC0912 is an experimental drug having similar active ingredient but containing a different preservative as that in Reference0912. Patients with open angle glaucoma or ocular hypertension will be enrolled and randomly assigned to receive either product. One drop will be instilled to the study eye nightly at 8:00 PM.

Timeline

Start
2010-07
Primary completion
2012-05
Completion
2012-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Reference0912 Unknown — Topical
Subject SPARC0912 Unknown — Topical