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

Sponsor

Ocuphire Pharma, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT04004507

Collaborator

Ophthalmic Consultants of Long Island (Other)

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Decrease in Night Vision Disturbance; Vision, Loss	Drug: Phentolamine Mesylate Ophthalmic Solution 1% Other: Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 1, 2007

Actual Primary Completion Date :

Oct 1, 2007

Actual Study Completion Date :

Feb 1, 2008

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Contrast Sensitivity [1 day]
Average change in monocular contrast sensitivity scores under mesopic conditions at each of five spatial frequencies with and without glare

Secondary Outcome Measures

Visual Acuity [1 day]
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)
Wavefront Aberrometry [1 day]
Wavefront aberrometry under mesopic conditions
Self-Reported Vision Quality [1 day]
Subjective patient evaluations of vision quality
Pupil Diameter [1 day]
Average change in pupil diameter

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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