Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis in Pediatric Subjects
Completed · Phase 3
Conditions studied: Mydriasis, Dilation
In brief
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."
Key facts
- Study ID
- NCT05223478
- Run by
- Ocuphire Pharma, Inc.
- People needed
- 23
- Starts
- 2021-12-17
- Expected to finish
- 2022-04-28
- Last updated by the study team
- 2023-09-05
Who can join
Age: 3 and older, up to 11. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Clinical Site 1 — Longwood, Florida, United States
- Clinical Site 2 — Athens, Ohio, United States
Full record on ClinicalTrials.gov
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