drugset
drugset / Trial / NCT05646719

Safety and Efficacy of Nyxol Eye Drops as a Single Agent and With Adjunctive Low-Dose Pilocarpine Eye Drops in Subjects With Presbyopia

NCT05646719 ↗

Phase 3 Completed 333 enrolled Ocuphire Pharma, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The objectives of this study are: To evaluate the safety and efficacy of Nyxol alone and with adjunctive low dose pilocarpine to improve distance-corrected near visual acuity (DCNVA) in subjects with presbyopia.

Timeline

Start
2022-12-22
Primary completion
2023-10-11
Completion
2023-10-11

Outcome

Met primary endpoint

registry Nyxol + Low Dose Pilocarpine vs Placebo + Low Dose Pilocarpine Vehicle; p <0.01 NCT05646719 ↗

release “The VEGA-2 Phase 3 study evaluating phentolamine ophthalmic solution 0.75% in presbyopia achieved its primary endpoint.” opusgtx.com ↗

release “A Phase 2 and the first Phase 3 trial for the use of Phentolamine Ophthalmic Solution 0.75% to treat presbyopia met their primary endpoints.” opusgtx.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Phentolamine Small molecule 0.75 % Other
Subject Pilocarpine Unknown 0.4 % Other

Indications

presbyopia