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This mechanism helps restore accommodation and improve near vision in presbyopic patients without the systemic effects of oral alpha-blockers.","oneSentence":"Phentolamine is an alpha-adrenergic antagonist that blocks norepinephrine signaling in the eye to reduce pupil dilation and improve visual function in patients with presbyopia.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:55:14.533Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Presbyopia (age-related loss of accommodation)"}]},"trialDetails":[{"nctId":"NCT06542497","phase":"PHASE3","title":"Evaluate Efficacy and Safety of POS to Improve Distance-corrected Near Visual in Participants With Presbyopia","status":"COMPLETED","sponsor":"Ocuphire Pharma, Inc.","startDate":"2024-08-15","conditions":"Presbyopia","enrollment":569},{"nctId":"NCT05646719","phase":"PHASE3","title":"Safety and Efficacy of Nyxol Eye Drops as a Single Agent and With Adjunctive Low-Dose Pilocarpine Eye Drops in Subjects With Presbyopia","status":"COMPLETED","sponsor":"Ocuphire Pharma, Inc.","startDate":"2022-12-22","conditions":"Presbyopia","enrollment":333},{"nctId":"NCT06349759","phase":"PHASE3","title":"Safety and Efficacy of 0.75% Phentolamine Ophthalmic Solution in Subjects With Post-refractive Surgery Visual Disturbances","status":"COMPLETED","sponsor":"Ocuphire Pharma, Inc.","startDate":"2024-04-01","conditions":"Mesopic Vision, Night Vision Loss","enrollment":200},{"nctId":"NCT04638660","phase":"PHASE3","title":"Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) in Subjects With Dim Light Vision Disturbances","status":"COMPLETED","sponsor":"Ocuphire Pharma, Inc.","startDate":"2020-12-30","conditions":"Dim Light Vision Disturbances","enrollment":144},{"nctId":"NCT04675151","phase":"PHASE2","title":"Safety and Efficacy of Nyxol With Pilocarpine Eye Drops in Subjects With Presbyopia","status":"COMPLETED","sponsor":"Ocuphire Pharma, Inc.","startDate":"2021-02-15","conditions":"Presbyopia","enrollment":150},{"nctId":"NCT07140783","phase":"PHASE3","title":"OPI-NXYDLD-303 Safety and Efficacy of Phentolamine Ophthalmic Solution in Keratorefractive Surgery Participants With Decreased Mesopic Visual Acuity","status":"RECRUITING","sponsor":"Ocuphire Pharma, Inc.","startDate":"2025-09-02","conditions":"Vision Loss Night, Vision Disorders","enrollment":200},{"nctId":"NCT07012512","phase":"NA","title":"Adjusted Study Protocol: Within-Subject Paired-Eye Design Comparing Pilocarpine 0.1%, Phentolamine 0.75%, and Combination Therapy for Cyclopentolate Reversal in Children","status":"NOT_YET_RECRUITING","sponsor":"Mansoura University","startDate":"2025-06-01","conditions":"Pupillary Constriction, Accomodation","enrollment":60},{"nctId":"NCT04620213","phase":"PHASE3","title":"Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis","status":"COMPLETED","sponsor":"Ocuphire Pharma, Inc.","startDate":"2020-11-18","conditions":"Mydriasis, Dilation","enrollment":185},{"nctId":"NCT05223478","phase":"PHASE3","title":"Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis in Pediatric Subjects","status":"COMPLETED","sponsor":"Ocuphire Pharma, Inc.","startDate":"2021-12-17","conditions":"Mydriasis, Dilation","enrollment":23},{"nctId":"NCT05134974","phase":"PHASE3","title":"Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis (MIRA-3)","status":"COMPLETED","sponsor":"Ocuphire Pharma, Inc.","startDate":"2021-11-18","conditions":"Mydriasis, Dilation","enrollment":368}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":2,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Nyxol","Nyxol®"],"phase":"phase_3","status":"active","brandName":"Phentolamine Ophthalmic Solution 0.75%","genericName":"Phentolamine Ophthalmic Solution 0.75%","companyName":"Ocuphire Pharma, Inc.","companyId":"ocuphire-pharma-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Phentolamine is an alpha-adrenergic antagonist that blocks norepinephrine signaling in the eye to reduce pupil dilation and improve visual function in patients with presbyopia. Used for Presbyopia (age-related loss of accommodation).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":3,"withResults":3},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}