drugset / Trial / NCT01703559

The Safety and Efficacy of Phentolamine Mesylate Ophthalmic Solution in Subjects With Severe Night Vision Disturbances

NCT01703559

Phase 2 Completed 60 enrolled Ocuphire Pharma, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The objectives of this study are: * To evaluate the efficacy of phentolamine mesylate 0.5% and 1.0% ophthalmic solution (Nyxol) in the treatment of night vision complaints, including reduced contrast sensitivity * To evaluate the ocular and systemic safety of phentolamine mesylate 0.5% and 1.0% ophthalmic solution (Nyxol) compared to its vehicle, a sterile, isotonic, buffered aqueous solution containing mannitol and sodium acetate

Timeline

Start
2011-09-09
Primary completion
2012-04-16
Completion
2012-04-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Phentolamine Small molecule 0.5 % Other
Subject Phentolamine Small molecule 1 % Other

Indications