Phase 3
N=368
Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis (MIRA-3)
Mydriasis · Dilation
Bottom Line
View on ClinicalTrials.gov: NCT05134974 ↗Enrolled (actual)
368
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcome: Primary: Percent of Subjects' Study Eyes With Pupil Diameter Returning to Baseline — 142; 7; 102; 117 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Phentolamine Ophthalmic Solution 0.75% (Drug); Phentolamine Ophthalmic Solution Vehicle (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Ocuphire Pharma, Inc.
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Subjects' Study Eyes With Pupil Diameter Returning to Baseline |
10; 5; 234; 119; 103; 3 | — |
| SECONDARY Percent of Subjects' Study Eyes With Pupil Diameter Returning to Baseline |
10; 5; 234; 119; 103; 3 | — |
| SECONDARY Pupil Diameter (Change From Max) |
-0.109; 0.092; -1.457; -0.059; -2.157; -0.284 | — |
| SECONDARY Percent of Subjects With Unchanged Accommodation From Baseline |
155; 65; 89; 59; 165; 66 | — |
| SECONDARY Change From Baseline in Best-Corrected Distance Visual Acuity (BCDVA) Under Normal Photopic Lighting Without Glare Conditions |
0.3; -0.2 | — |
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
* To evaluate the systemic exposure of Nyxol on pharmacokinetic (PK) sampling
Eligibility Criteria
Inclusion Criteria
- Males or females ≥ 12 years of age
- Ability to comply with all protocol-mandated procedures independently and to attend all scheduled office visits
Exclusion Criteria
- Clinically significant ocular disease as deemed by the Investigator (eg, glaucoma, corneal edema, uveitis, severe keratoconjunctivitis sicca) 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, with the exception of lid scrubs with OTC products (eg, OCuSOFT® lid scrub, SteriLid®, baby shampoo, etc.)
- 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
- Prior participation in a study involving the use of Nyxol for the reversal of mydriasis
- Known hypersensitivity or contraindication to α- and/or β-adrenoceptor antagonists
- Clinically significant systemic disease (eg, uncontrolled diabetes, myasthenia gravis, cancer, hepatic, renal, endocrine, or cardiovascular disorders) that might interfere with the study
- Participation in any investigational study within 30 days prior to screening
- Resting heart rate (HR) outside the normal range (50-110 beats per minute) at the Screening Visit.
- Hypertension with resting diastolic blood pressure (BP)>105 mmHg or systolic BP > 160 mmHg at the Screening Visit.
Data sourced from ClinicalTrials.gov (NCT05134974). 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.