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

The objectives of this study are:

• To assess the effect of ophthalmic phentolamine mesylate in mesopic conditions on the four endpoints:

  1. Contrast sensitivity
  2. Low contrast visual acuity
  3. Wavefront aberrometry
  4. Subjective questionnaire
• To assess the safety of ophthalmic phentolamine mesylate

Study Overview

• Status: Completed
• Conditions: Decrease in Night Vision; Disturbance; Vision, Loss
• Intervention / Treatment: Other: Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo); Drug: Phentolamine Mesylate Ophthalmic Solution 1%

Detailed Description

Double-masked, placebo-controlled, single-dose Phase 2 study in 24 patients experiencing severe night vision difficulties to evaluate ocular and systemic safety and efficacy following administration of one drop of phentolamine mesylate 1.0% QD in each eye for 1 day.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • Lynbrook, New York, United States, 11563
      • Ophthalmic Consultants of Long Island, NY

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phentolamine Mesylate Ophthalmic Solution 1%; 1 drop in each eye (QD) for one day.	Drug: Phentolamine Mesylate Ophthalmic Solution 1%; Topical Sterile Ophthalmic Solution
Placebo Comparator: Phentolamine Mesylate Ophthalmic Solution Vehicle; 1 drop in each eye (QD) for one day.	Other: Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo); Topical Sterile Ophthalmic Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Acuity	Average number of letters of improvement in the following parameters: Distance high-contrast visual acuity under mesopic conditions (monocular, measured at 4 meters); Distance high-contrast visual acuity under photopic conditions (monocular, measured at 4 meters); Distance low-contrast visual acuity under mesopic conditions (monocular, measured at 4 meters); Distance low-contrast visual acuity under photopic conditions (monocular, measured at 4 meters)	1 day
Pupil Diameter	Average change in pupil diameter	1 day
Self-Reported Vision Quality	Subjective patient evaluations of vision quality at night (% rating their vision as improved)	1 day

Collaborators and Investigators

• Sponsor: Ocuphire Pharma, Inc.
• Collaborators: Ophthalmic Consultants of Long Island
• Investigators: Principal Investigator: Marguerite McDonald, MD, FACS, Ophthalmic Consultants of Long Island, NY

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2007
• Primary Completion (Actual): October 1, 2007
• Study Completion (Actual): February 1, 2008

Study Registration Dates

• First Submitted: June 28, 2019
• First Submitted That Met QC Criteria: June 28, 2019
• First Posted (Actual): July 2, 2019

Study Record Updates

• Last Update Posted (Estimated): February 15, 2024
• Last Update Submitted That Met QC Criteria: June 22, 2023
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Nyxol; Glare; Halos; Starbursts; Night Vision Disturbances; NVD
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Adrenergic alpha-Antagonists; Ophthalmic Solutions; Pharmaceutical Solutions; Phentolamine
• Other Study ID Numbers: NYX-SNV

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No