Study Eye Change from Baseline (-1 Hour) Conjunctival Hyperemia Grading; Cornea and Contact Lens Research Unit (CCLRU scale) Grades range from 0 to 3, with 3 being considered the most severe.
Change (in mm) in Pupil Diameter from Max Pupil Dilation (0 minutes) (Study Eye)
90 Minutes
Group
Value
95% CI
Phentolamine Ophthalmic Solution 0.75%
-1.475
± 0.7188
Phentolamine Ophthalmic Solution Vehicle
-0.378
± 0.4473
3 Hours
Group
Value
95% CI
Phentolamine Ophthalmic Solution 0.75%
-2.031
± 0.6919
Phentolamine Ophthalmic Solution Vehicle
-0.723
± 0.6470
24 Hours
Group
Value
95% CI
Phentolamine Ophthalmic Solution 0.75%
-2.005
± 1.2841
Phentolamine Ophthalmic Solution Vehicle
-1.44
± 1.2891
Efficacy Measurement: Pupil DiameterSecondary· Up to 24 Hours
Time (Hours) to Return to ≤ 0.2 mm from Baseline (-1 Hour) Pupil Diameter (Time-savings Analysis) (Study Eye)
Group
Value
95% CI
Phentolamine Ophthalmic Solution 0.75%
2.95
± 2.564
Phentolamine Ophthalmic Solution Vehicle
5.54
± 3.078
Sponsor's own description
The objectives of this study are:
* To evaluate the safety of Nyxol in pediatric subjects
* To evaluate the efficacy of Nyxol to expedite the reversal of pharmacologically induced mydriasis in pediatric subjects The Sponsor intends to use this study to evaluate Nyxol in pediatric subjects aged 3 to 11 for the indication "the treatment of pharmacologically induced mydriasis produced by adrenergic (phenylephrine) or parasympatholytic (tropicamide) agents, or a combination thereof."
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
Other trials of Phentolamine Ophthalmic Solution 0.75%
Trials testing the same drug.
NCT05134974 — Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis (MI
· Phase 3
· completed
NCT04675151 — Safety and Efficacy of Nyxol With Pilocarpine Eye Drops in Subjects With Presbyopia
· Phase 2
· completed
NCT04638660 — Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) in Subjects With Dim Light Vision Disturbances
· Phase 3
· completed
NCT04620213 — Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis
· Phase 3
· completed
Other Ocuphire Pharma, Inc. trials
Trials by the same sponsor.
NCT06542497 — Evaluate Efficacy and Safety of POS to Improve Distance-corrected Near Visual in Participants With Presbyopia
· Phase 3
· completed
NCT06349759 — Safety and Efficacy of 0.75% Phentolamine Ophthalmic Solution in Subjects With Post-refractive Surgery Visual Disturbanc
· Phase 3
· completed
NCT05646719 — Safety and Efficacy of Nyxol Eye Drops as a Single Agent and With Adjunctive Low-Dose Pilocarpine Eye Drops in Subjects
· Phase 3
· completed
NCT05134974 — Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis (MI
· Phase 3
· completed
NCT04692688 — Study of the Safety and Efficacy of APX3330 in Diabetic Retinopathy
· Phase 2
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Ocuphire Pharma, Inc.
Last refreshed: 5 September 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05223478.