Phase 3
N=23
Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis in Pediatric Subjects
Mydriasis · Dilation
Bottom Line
View on ClinicalTrials.gov: NCT05223478 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcome: Primary: Safety Measurements — 0.3; -0.2; 1.6; 0.0 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Phentolamine Ophthalmic Solution 0.75% (Drug); Phentolamine Ophthalmic Solution Vehicle (Drug)
- Age
- Pediatric · 3+ yrs
- Sex
- All
- Sponsor
- Ocuphire Pharma, Inc.
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety Measurements |
0.3; -0.2; 1.6; 0.0; 1.1; -0.1 | — |
| PRIMARY Vital Signs |
-4.6; -0.8; -2.8; -5.8 | — |
| PRIMARY Vital Signs |
-4.6; -0.8; -2.8; -5.8 | — |
| PRIMARY Safety Measurement |
-1.2; -0.3; 1.2; 0.1; 1.5; 0.7 | — |
| PRIMARY Change From Screening Blood Pressure (Diastolic) |
-2.4; 1.0; -1.1; -3.8 | — |
| SECONDARY Efficacy Measurement: Pupil Diameter |
2.95; 5.54 | — |
| SECONDARY Efficacy Measurement: Pupil Diameter |
2.95; 5.54 | — |
| SECONDARY Efficacy Measurement: Pupil Diameter |
2.95; 5.54 | — |
Summary
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."
Eligibility Criteria
Inclusion Criteria
- Males or premenstrual females 3 to 11 years of age
- Ability to comply with all protocol-mandated procedures independently and to attend all scheduled office visits
- Parent/Legal guardian willing to give written informed consent to participate in this study. Children aged 7 to 11 years to provide signed assent form, as well as a separate parental/legal guardian consent.
Exclusion Criteria
- Clinically significant ocular disease as deemed by the Investigator(eg, amblyopia, congenital cataract, congenital glaucoma) that might interfere with the study
- Unwilling or unable to discontinue use of contact lenses at screening until study completion
- Unwilling or unable to suspend use of topical medication at screening until study completion
- Ocular trauma or ocular surgery within the 6 months prior to screening
- Use of any topical prescription or over-the-counter (OTC)ophthalmic medications of any kind within 7 days of screening
- Recent or current evidence of ocular infection or inflammation in either eye (such as current evidence of clinically significant blepharitis, conjunctivitis, or keratitis). Subjects must be symptom-free for at least 7 days prior to screening
- Closed or very narrow-angle that in the Investigator's opinion is potentially occludable if the subject's pupil is dilated
- History of any traumatic (surgical or nonsurgical) or non-traumatic condition affecting the pupil or iris
- Known allergy, hypersensitivity, or contraindication to any component of the phentolamine ophthalmic solution or to any component of the mydriatic agents or vehicle formulation
Systemic:
- Known hypersensitivity or contraindication to α- and/or β-adrenoceptor antagonists
- Clinically significant systemic disease (eg, uncontrolled diabetes, cancer, hepatic, renal, endocrine, or cardiovascular disorders) that in the opinion of the Investigator could interfere with the study
- Subjects with learning disabilities that in the opinion of the investigator could interfere with the study
- Initiation of treatment with or any changes to the current dosage, drug, or regimen of any systemic adrenergic or cholinergic drugs within 7 days prior to screening or during the study(Appendix 4)
- Participation in any investigational study within 30 days prior to screening
Data sourced from ClinicalTrials.gov (NCT05223478). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.