Phase 3
N=185
Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis
Mydriasis · Dilation
Bottom Line
View on ClinicalTrials.gov: NCT04620213 ↗Enrolled (actual)
185
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcome: Primary: Percent of Subjects' Study Eyes With Pupil Diameter Returning to Baseline — 46; 6 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Phentolamine Ophthalmic Solution 0.75% (Drug); Phentolamine Ophthalmic Solution Vehicle (Placebo) (Other)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Ocuphire Pharma, Inc.
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Subjects' Study Eyes With Pupil Diameter Returning to Baseline |
46; 6 | — |
| SECONDARY Percent of Subjects' Study Eyes Pupil Diameter Returning to Baseline |
1; 3; 26; 2; 46; 6 | — |
| SECONDARY Pupil Diameter (Change From Max) |
5.085; 5.177; 7.207; 7.197; 0.025; 0.075 | — |
| SECONDARY Percent of Subjects With Unchanged Accommodation From Baseline |
30; 37; 26; 18; 29; 39 | — |
Summary
The objectives of this study are:
* To evaluate the efficacy of Nyxol to expedite the reversal of pharmacologically-induced mydriasis across multiple mydriatic agents with an emphasis on phenylephrine
* To evaluate the efficacy of Nyxol to return subjects to baseline accommodation after worsening (with cycloplegic agents tropicamide and Paremyd)
* To evaluate the safety of Nyxol
* To evaluate any additional benefits of the reversal of pharmacologically-induced mydriasis
Eligibility Criteria
Inclusion Criteria
- Males or females ≥ 12 years of age
- Otherwise healthy and well controlled subjects
Exclusion Criteria
Ophthalmic (in either eye):
- Clinically significant ocular disease as deemed by the Investigator 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, ocular surgery or non-refractive laser treatment 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
- History of diabetic retinopathy or diabetic macular edema
- Closed or very narrow angles that in the Investigator's opinion are 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 or contraindication to any component of the mydriatic agents or the vehicle formulation
- History of cauterization of the punctum or punctal plug (silicone or collagen) insertion or removal
Systemic:
- Known hypersensitivity or contraindication to α- and/or β adrenoceptor antagonists.
- Clinically significant systemic disease that might 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
- Participation in any investigational study within 30 days prior to screening
- Females of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control
- Resting HR outside the normal range (50-110 beats per minute)
- Hypertension with resting diastolic BP > 105 mmHg or systolic BP > 160 mmHg
Data sourced from ClinicalTrials.gov (NCT04620213). 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.