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
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
24
Topical Sterile Ophthalmic Solution
Topical Sterile Ophthalmic Solution
Ophthalmic Consultants of Long Island, NY
Lynbrook, New York, United States
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.
Time frame: 1 day
Visual Acuity
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)
Time frame: 1 day
Self-Reported Vision Quality
Subjective patient evaluations of vision quality at night (% rating their vision as improved)
Time frame: 1 day
Pupil Diameter
Average change in pupil diameter
Time frame: 1 day
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