Status:
COMPLETED
Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis in Pediatric Subjects
Lead Sponsor:
Ocuphire Pharma, Inc.
Conditions:
Mydriasis
Dilation
Eligibility:
All Genders
3-11 years
Phase:
PHASE3
Brief 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 pediat...
Detailed Description
This is a randomized, parallel-arm, double-masked, placebo-controlled study in approximately 20 randomized pediatric subjects evaluating the safety and efficacy of Nyxol in pediatric subjects with pha...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 28 2022
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT05223478
Start Date
December 17 2021
End Date
April 28 2022
Last Update
September 5 2023
Active Locations (2)
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1
Clinical Site 1
Longwood, Florida, United States, 32779
2
Clinical Site 2
Athens, Ohio, United States, 45701