Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) in Subjects With Dim Light Vision Disturbances

NCT04638660 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: OPI-NYXDLD-301 (LYNX-1)
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 17

Brief Summary

The objectives of this study are:

• To evaluate the efficacy of Nyxol to improve mesopic low contrast visual acuity (mLCVA) in subjects with Dim Light Vision Disturbances (DLD)
• To evaluate efficacy of Nyxol to improve visual performance
• To evaluate the safety of Nyxol

Conditions

Dim Light Vision Disturbances

Keywords

Nyxol, Night Vision Disturbances, Glare, Halos, Starbursts

Outcome Measures

Primary Outcomes (1)

• Percent of Subjects With 3 Lines mLCVA Improvement in Study Eye

  Percent of subjects with ≥ 15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (≥3 lines) of improvement in the study eye compared to baseline in monocular mLCVA at Day 8

  8 days

Secondary Outcomes (4)

• Percent of Subjects With mLCVA Improvement in Study Eye

  up to 15 days

• Percent of Subjects With Photopic Low Contrast Visual Acuity (pLCVA) and mHCVA Improvement in Study Eye

  up to 15 days

• Change From Baseline in Study Eye Mesopic Pupil Diameter (PD)

  up to 15 days

• Percent Change From Baseline in Study Eye Mesopic Pupil Diameter (PD)

  up to 15 days

Study Arms (2)

Phentolamine Ophthalmic Solution 0.75%

EXPERIMENTAL

One drop in both eyes at or near bedtime (8PM to 10PM)

Drug: Phentolamine Ophthalmic Solution 0.75%

Phentolamine Ophthalmic Solution Vehicle

PLACEBO COMPARATOR

One drop in both eyes at or near bedtime (8PM to 10PM)

Drug: Phentolamine Ophthalmic Solution Vehicle (Placebo)

Interventions

Phentolamine Ophthalmic Solution 0.75% DRUG

0.75% phentolamine ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist

Also known as: Nyxol, Nyxol®

Phentolamine Ophthalmic Solution 0.75%

Phentolamine Ophthalmic Solution Vehicle (Placebo) DRUG

Topical sterile ophthalmic solution

Phentolamine Ophthalmic Solution Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females ≥ 18 years of age
• Subject-reported DLD (likely subjects with a history of multifocal IOLs, post-laser-assisted in situ keratomileusis \[LASIK\], corneal scars, and keratoconus)
• Ability to comply with all protocol-mandated procedures independently and to attend all
• Otherwise healthy and well-controlled subjects
• Able and willing to give written consent to participate in this study
• Able to self-administer study medication
• PD ≥ 6 mm under mesopic conditions (prior to illumination) in at least one eye
• ≤ 20 (20/100 Snellen or worse) ETDRS letters in mLCVA score
• ≥10 ETDRS letters ( ≥2 lines) improvement in mLCVA in at least one eye during illumination of the contralateral eye with a BAT system on low setting

You may not qualify if:

• Ophthalmic:
• Prior history of dry eye diagnosis, taking prescription drops for dry eye, or taking artificial tear drops occasionally for dry eye
• Prior history of fluctuating vision
• Clinically significant ocular disease as deemed by the Investigator that might interfere with the study
• Known hypersensitivity to any topical alpha-adrenoceptor antagonists
• Known allergy or contraindication to any component of the vehicle formulation
• History of cauterization of the punctum or punctal plug (silicone or collagen) insertion or removal
• Ocular trauma, ocular surgery (e.g., IOLs) or laser procedure (e.g., LASIK, photorefractive keratectomy \[PRK\]) within 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. Subjects must be symptom free for at least 7 days.
• History of diabetic retinopathy, diabetic macular edema, or dry or wet macular degeneration
• History of any traumatic (surgical or nonsurgical) or nontraumatic condition affecting the pupil or iris
• Unwilling or unable to discontinue use of contact lenses at screening until study completion, except for keratoconus subjects who may wear contacts up to 24 hours prior to their scheduled visits
• Systemic:
• Known hypersensitivity or contraindication to alpha- and/or beta-adrenoceptor antagonists

Sponsors & Collaborators

• Ocuphire Pharma, Inc.: lead

Study Sites (17)

Clinical Site 6

Newport Beach, California, 92663, United States

Location

Clinical Site 1

Petaluma, California, 94954, United States

Location

Clinical Site 3

Jacksonville, Florida, 32204, United States

Location

Clinical Site 18

Jacksonville, Florida, 32256, United States

Location

Clinical Site 13

Pittsburg, Kansas, 66762, United States

Location

Clinical Site 20

Edgewood, Kentucky, 41017, United States

Location

Clinical Site 14

Louisville, Kentucky, 41008, United States

Location

Clinical Site 10

Palisades Park, New Jersey, 07650, United States

Location

Clinical Site 8

Pennington, New Jersey, 08534, United States

Location

Clinical Site 4

Elizabeth City, North Carolina, 27909, United States

Location

Clinical Site 22

High Point, North Carolina, 27262, United States

Location

Clinical Site 9

High Point, North Carolina, 27262, United States

Location

Clinical Site 2

Fargo, North Dakota, 58103, United States

Location

Clinical Test 15

Warwick, Rhode Island, 57108, United States

Location

Clinical Site 11

Memphis, Tennessee, 38119, United States

Location

Clinical Site 5

San Antonio, Texas, 78240, United States

Location

Clinical Site 19

Ogden, Utah, 84403, United States

Location

Results Point of Contact

• Title: Drey Coleman
• Organization: Ocuphire Pharma, Inc.

dcoleman@ocuphire.com

8134041993

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All subjects will be randomized into the study in a 1:1 ratio to one of the treatment arms (Nyxol or placebo), with a stratification by light/dark irides.

Study Record Dates

• First Submitted: November 16, 2020
• First Posted: November 20, 2020
• Study Start: December 30, 2020
• Primary Completion: May 19, 2022
• Study Completion: May 19, 2022
• Last Updated: October 14, 2025
• Results First Posted: August 9, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (17)