Single Dose Study of Phentolamine Mesylate Eye Drops in Patients With Severe Night Vision Disturbances

NCT04004507 | Completed Phase 2 Results FDA Drug

• 1 other identifier: NYX-SNV
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of this study are:

• To assess the safety of ophthalmic phentolamine mesylate

Conditions

Decrease in Night Vision; Disturbance; Vision, Loss

Keywords

Night Vision Disturbances; NVD; Glare; Halos; Starbursts; Nyxol

Outcome Measures

Primary Outcomes (1)

• Contrast Sensitivity

  Average change in monocular contrast sensitivity scores under mesopic conditions at each of five spatial frequencies with and without glare. The tests were performed in a darkened room using the Optec 6500 instrument (Stereo Optical) using Slides 5-9 (spatial frequencies 1.5 - 18 cycles per degree), with the distance setting at "far", and with the light setting at "night". Subjects were asked to read each slide from left to right indicating if the lines were tilted to the left, the right or straight up and down until they provided 2 consecutive incorrect responses. The total number of correct responses for each slide was recorded.

  1 day

Secondary Outcomes (3)

• Visual Acuity

  1 day

• Self-Reported Vision Quality

  1 day

• Pupil Diameter

  1 day

Study Arms (2)

Phentolamine Mesylate Ophthalmic Solution 1%

EXPERIMENTAL

1 drop in each eye (QD) for one day.

Drug: Phentolamine Mesylate Ophthalmic Solution 1%

Phentolamine Mesylate Ophthalmic Solution Vehicle

PLACEBO COMPARATOR

1 drop in each eye (QD) for one day.

Other: Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)

Interventions

Phentolamine Mesylate Ophthalmic Solution 1% DRUG

Topical Sterile Ophthalmic Solution

Phentolamine Mesylate Ophthalmic Solution 1%

Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo) OTHER

Topical Sterile Ophthalmic Solution

Phentolamine Mesylate Ophthalmic Solution Vehicle

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients ≥ 18 years of age
• Currently experiencing severe night vision difficulty as reported subjectively
• At least two patches below the normal range at any two frequencies in Contrast Sensitivity done under mesopic conditions with glare
• Improvement in low contrast visual acuity (LCVA) in dim light during illumination of contralateral eye
• Good general health
• Written informed consent to participate in this trial
• Ability to comply with all protocol mandated procedures and to attend all scheduled office visits

You may not qualify if:

• Patients with untreated cataracts grades 1-4
• Patients who wear contact lenses
• Less than 5 weeks post-refractive surgery (LASIK or PRK)
• Less than 5 weeks post intraocular lens insertion
• Low blood pressure (systolic \<120 mm Hg or diastolic \<80 mm Hg)
• A history of heart rate abnormalities
• Administration of any investigational drug within 30 days of study initiation
• Use of any eye drops with a pharmacologic effect on the pupil within 7 days of Visit 1
• Use of any systemic alpha adrenergic antagonists (Appendix 1)
• Known local or systemic hypersensitivity to adrenergic antagonists
• For women of childbearing potential: currently pregnant or lactating, or unwilling to use birth control during the study

Sponsors & Collaborators

• Ocuphire Pharma, Inc.: lead
• Ophthalmic Consultants of Long Island: collaborator

Study Sites (1)

Ophthalmic Consultants of Long Island, NY

Lynbrook, New York, 11563, United States

Location

Related Publications (1)

• Pepose J, Brigell M, Lazar E, Heisel C, Yousif J, Rahmani K, Kolli A, Hwang M, Mitrano C, Lazar A, Charizanis K, Sooch M, McDonald M. A randomized phase 2 clinical trial of phentolamine mesylate eye drops in patients with severe night vision disturbances. BMC Ophthalmol. 2022 Oct 8;22(1):402. doi: 10.1186/s12886-022-02621-6.

  PMID: 36209072 DERIVED

Results Point of Contact

• Title: Dr. Marguerite McDonald
• Organization: Ophthalmic Consultants Of Long Island

margueritemcdmd@aol.com

7342501718

Study Officials

• Marguerite McDonald, MD, FACS

  Ophthalmic Consultants of Long Island, NY

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2019
• First Posted: July 2, 2019
• Study Start: August 1, 2007
• Primary Completion: October 1, 2007
• Study Completion: February 1, 2008
• Last Updated: February 15, 2024
• Results First Posted: February 15, 2024

Record last verified: 2022-05

Locations

US (1)