Safety and Efficacy of Ophthalmic Phentolamine Mesylate to Reverse Pharmacologically Induced Mydr… (NCT04024891) | Clinical Trial Compass
CompletedPhase 2
Safety and Efficacy of Ophthalmic Phentolamine Mesylate to Reverse Pharmacologically Induced Mydriasis
United States32 participantsStarted 2019-08-13
Plain-language summary
The objectives of this study are:
* To evaluate the efficacy of Nyxol (phentolamine mesylate ophthalmic solution 1%) to expedite the reversal of pharmacologic mydriasis
* To evaluate the safety of Nyxol
* To evaluate the effect of Lumify® to suppress conjunctival hyperemia (redness) potentially associated with administration of Nyxol
Who can participate
Age range18 Years – 45 Years
SexALL
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Inclusion criteria
✓. Males or females ≥ 18 and ≤ 45 years of age with brown irides (irises) only
✓. Otherwise healthy and well controlled subjects
✓. Able to comply with all protocol mandated procedures and to attend all scheduled office visits
✓. Willing to give written informed consent to participate in this study
Exclusion criteria
✕. Clinically significant ocular disease as deemed by the Investigator (e.g., cataract, glaucoma, corneal edema, uveitis, severe keratoconjunctivitis sicca) that might interfere with the study
✕. Unwilling or unable to discontinue use of contact lenses during treatment visits
✕. Ocular trauma, ocular surgery or non-refractive laser treatment within the 6 months prior to screening
✕. Ocular medication of any kind within 30 days of screening, with the exception of a) lid scrubs (which may have been used prior to, but not after screening) or b) lubricating drops for dry eye (preservative-free artificial tears), which may be used in between the study treatment days
✕. Recent or current evidence of ocular infection or inflammation. Current evidence of clinically significant blepharitis, conjunctivitis, or a history of herpes simplex or herpes zoster keratitis at screening
✕. History of diabetic retinopathy
✕. 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 (e.g., irregularly shaped pupil, neurogenic pupil disorder, iris atrophy, iridotomy)