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

Study Overview
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Brief Summary
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The objectives of this study are: To assess the effect of ophthalmic phentolamine mesylate in mesopic conditions on the four endpoints: Contrast sensitivity Low contrast visual acuity Wavefront aberrometry Subjective questionnaire To assess the safety of ophthalmic phentolamine mesylate

Detailed Description
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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.

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

Conditions
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Decrease in Night Vision, Disturbance; Vision, Loss

Intervention / Treatment
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* Drug: Phentolamine Mesylate Ophthalmic Solution 1%
* Other: Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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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 | 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 | 
| Wavefront Aberrometry | Wavefront aberrometry under mesopic conditions | 1 day | 
| Self-Reported Vision Quality | Subjective patient evaluations of vision quality | 1 day | 
| Pupil Diameter | Average change in pupil diameter | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Night Vision Disturbances, NVD, Glare, Halos, Starbursts, Nyxol