Safety and Efficacy of Ophthalmic Phentolamine Mesylate to Reverse Pharmacologically Induced Mydriasis

Phase 2 Completed 32 enrolled Ocuphire Pharma, Inc.

RandomizedCrossoverTriple-blindTreatment

Summary

The objectives of this study are: * To evaluate the efficacy of Nyxol (phentolamine mesylate ophthalmic solution 1%) to expedite the reversal of pharmacologic mydriasis * To evaluate the safety of Nyxol * To evaluate the effect of Lumify® to suppress conjunctival hyperemia (redness) potentially associated with administration of Nyxol

Timeline

Start: 2019-08-13
Primary completion: 2019-09-17
Completion: 2019-09-17

Publications

Karpecki PM, Foster SA, Montaquila SM, Kannarr SR, Slonim CB, Meyer AR, Sooch MP, Jaber RM, Charizanis K, Yousif JE, Klapman SA, Amin AT, McDonald MB, Horn GD, Lazar ES, Pepose JS. Phentolamine Eye Drops Reverse Pharmacologically Induced Mydriasis in a Randomized Phase 2b Trial. Optom Vis Sci. 2021 Mar 1;98(3):234-242. doi: 10.1097/OPX.0000000000001656.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Phentolamine	Small molecule	1 %	Other

Indications

No indication recorded.