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Safety and Efficacy of Ophthalmic Phentolamine Mesylate to Reverse Pharmacologically Induced Mydriasis

NCT04024891 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2023-08-29

Study results available
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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

Conditions

  • Mydriasis
  • Dilation

Interventions

DRUG

Phentolamine Mesylate Ophthalmic Solution 1%

1% phentolamine mesylate ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist

OTHER

Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)

Topical Sterile Ophthalmic Solution

Sponsors & Collaborators

  • Ocuphire Pharma, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-08-13
Primary Completion
2019-09-17
Completion
2019-09-17
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04024891 on ClinicalTrials.gov