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

Phase 2

Completed

• Conditions: Disturbance; Vision, Loss; Decrease in Night Vision
• Interventions: Drug: Phentolamine Mesylate Ophthalmic Solution 1%; Other: Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)

• Registration Number: NCT04004507
• Lead Sponsor: Ocuphire Pharma, Inc.

Brief Summary

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

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 Timeline

• Study Start: 2007-08
• Primary Completion: 2007-10
• Study Completion: 2008-02
• Study First Submitted: 2019-06-28
• Study First Submitted QC: 2019-06-28
• Study First Posted: 2019-07-02
• Status Verified: 2022-05
• Results First Submitted: 2022-05-20
• Results First Submitted QC: 2023-06-22
• Last Update Submitted: 2023-06-22
• Results First Posted: 2024-02-15
• Last Update Posted: 2024-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phentolamine Mesylate Ophthalmic Solution 1%	Phentolamine Mesylate Ophthalmic Solution 1%	1 drop in each eye (QD) for one day.
Phentolamine Mesylate Ophthalmic Solution Vehicle	Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)	1 drop in each eye (QD) for one day.

Primary Outcome Measures

Name	Time	Method
Contrast Sensitivity	1 day	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.

Secondary Outcome Measures

Name	Time	Method
Self-Reported Vision Quality	1 day	Subjective patient evaluations of vision quality at night (% rating their vision as improved)
Pupil Diameter	1 day	Average change in pupil diameter
Visual Acuity	1 day	Average number of letters of improvement in the following parameters: 1. Distance high-contrast visual acuity under mesopic conditions (monocular, measured at 4 meters); 2. Distance high-contrast visual acuity under photopic conditions (monocular, measured at 4 meters); 3. Distance low-contrast visual acuity under mesopic conditions (monocular, measured at 4 meters); 4. Distance low-contrast visual acuity under photopic conditions (monocular, measured at 4 meters)

Trial Locations

Locations (1)

Ophthalmic Consultants of Long Island, NY; 🇺🇸 Lynbrook, New York, United States