CompletedPhase 3

Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis in Pediatric Subjects

United States23 participantsStarted 2021-12-17

Plain-language 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 pediatric subjects The Sponsor intends to use this study to evaluate Nyxol in pediatric subjects aged 3 to 11 for the indication "the treatment of pharmacologically induced mydriasis produced by adrenergic (phenylephrine) or parasympatholytic (tropicamide) agents, or a combination thereof."

Who can participate

Age range3 Years – 11 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 criteria

✕. 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

What they're measuring

Safety Measurements

Timeframe: 0 Minutes, 90 Minutes, 3 Hours, 24 Hours

Vital Signs

Timeframe: 3 Hours, 24 Hours

Vital Signs

Timeframe: 3 Hours, 24 Hours

Safety Measurement

Timeframe: 0 Minutes, 3 Hours, 24 Hours

Change From Screening Blood Pressure (Diastolic)

Timeframe: 3 Hours, 24 Hours

Trial details

NCT IDNCT05223478

SponsorOcuphire Pharma, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-04-18

Results submitted2023-06-22

View on ClinicalTrials.gov More Mydriasis trials

Plain-language summary

Who can participate

Age range3 Years – 11 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 criteria

✕. 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