Randomized, Double-masked, Placebo-controlled, Multicenter Study of the Efficacy and Safety of Phentolamine Ophthalmic Solution (POS) 0.75% in Participants With Presbyopia

Ocuphire Pharma, Inc.39 sites in 1 country569 target enrollmentAugust 15, 2024

ConditionsPresbyopia

Interventions0.75% phentolamine ophthalmic solution Placebo

Drugs0.75% phentolamine ophthalmic solution Placebo

Overview

Phase: Phase 3
Intervention: 0.75% phentolamine ophthalmic solution
Conditions: Presbyopia
Sponsor: Ocuphire Pharma, Inc.
Enrollment: 569
Locations: 39
Primary Endpoint: Primary efficacy endpoint
Status: Completed
Last Updated: last month

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials Related News

Overview

Brief Summary

Safety and efficacy of POS in participants with presbyopia

Detailed Description

Randomized, Double-Masked, Placebo-Controlled, Multicenter, Phase 3 Study of the Efficacy and Safety of Phentolamine Ophthalmic Solution (POS) 0.75% in Participants with Presbyopia

Registry

clinicaltrials.gov

Start Date

August 15, 2024

End Date

January 22, 2026

Last Updated

last month

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Ocuphire Pharma, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Participants must meet all of the following criteria:
•Males or females ≥ 45 and ≤ 64 years of age
•Able to comply with all protocol-mandated procedures independently and to attend all scheduled office visits
•Able and willing to give signed informed consent
•Able to self-administer study medication throughout the study period
•Inclusion criteria #5, #6, and #7 must all be met at both Screening and Baseline Visits:
•BCDVA of 55 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (20/20 Snellen equivalent) or better in photopic conditions in each eye
•DCNVA of 50 ETDRS letters (20/50 Snellen equivalent) or worse but not \<35 ETDRS letters (20/100 Snellen equivalent) in photopic conditions in each eye and binocularly
•For participants who depend on reading glasses or bifocals, binocular best-corrected near VA of 65 ETDRS letters (20/25 Snellen equivalent) or better
•Photopic PD of ≥ 4 mm in the study eye at Screening

Exclusion Criteria

•Excluded from the study will be individuals with any of the following characteristics:
•Ophthalmic (in either eye):
•Use of any topical prescription (including Vuity® or Qlosi™) or over-the-counter (OTC) ophthalmic medications of any kind within 7 days of Screening until study completion, with the exception of lid scrubs with OTC products (eg, OCuSOFT® lid scrub, SteriLid®, baby shampoo, etc.) and artificial tears as specified in Exclusion Criterion #2 below
•Use of any OTC artificial tears (preserved or unpreserved) during visit days or 15 min before or after instillation of study medication
•Use of Ryzumvi™ (POS) within 7 days prior to Screening
•Use of any dry eye product, such as topical ophthalmic therapy for dry eye (eg, generic cyclosporine, Restasis®, Xiidra®, Cequa®, Eysuvis®, and Meibo®) or intranasal dry eye product (eg, Tyrvaya®) or other devices within 12 months prior to Screening
•Tear break-up time of \< 5 seconds or corneal fluorescein staining (CFS) Grade ≥ 2 in the inferior zone or Grade ≥ 1 in the central zone using the National Eye Institute scale
•Clinically significant ocular disease (eg, cataract, glaucoma, corneal edema, uveitis, retinal degeneration, loss of visual field, or any macular pathology) that, in the judgment of the Investigator, might interfere with study procedures
•Recent or current evidence of ocular infection or inflammation in either eye (such as current evidence of clinically significant blepharitis, conjunctivitis, keratitis, etc.). Participants must be symptom free for at least 7 days prior to Screening
•Any history of herpes simplex or herpes zoster keratitis

Arms & Interventions

0.75% phentolamine ophthalmic solution

Drug: phentolamine ophthalmic solution 0.75%, a non-selective alpha-1 and alpha-2 adrenergic antagonist

Intervention: 0.75% phentolamine ophthalmic solution

phentolamine ophthalmic solution vehicle

Drug: Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Primary efficacy endpoint

Time Frame: Day 8

The primary efficacy endpoint is the percentage of participants with ≥ 15 letters of improvement in binocular DCNVA and with \< 5 letters of loss in binocular BCDVA from baseline comparing POS-treated participants to placebo-treated participants at 12 hours post-dose at Visit 4 (Day 8)