Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologicall… (NCT05134974) | Clinical Trial Compass
CompletedPhase 3
Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis (MIRA-3)
United States368 participantsStarted 2021-11-18
Plain-language 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
Who can participate
Age range12 Years
SexALL
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Inclusion criteria
✓. Males or females ≥ 12 years of age
âś“. Ability to comply with all protocol-mandated procedures independently and to attend all scheduled office visits
Exclusion criteria
âś•. Clinically significant ocular disease as deemed by the Investigator (eg, glaucoma, corneal edema, uveitis, severe keratoconjunctivitis sicca) that might interfere with the study
âś•. Unwilling or unable to discontinue use of contact lenses at screening until study completion
âś•. Unwilling or unable to suspend use of topical medication at screening until study completion
âś•. 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.)
âś•. 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
What they're measuring
1
Percent of Subjects' Study Eyes With Pupil Diameter Returning to Baseline