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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
Details
| Lead sponsor | Ocuphire Pharma, Inc. |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 24 |
| Start date | 2007-08 |
| Completion | 2008-02 |
Conditions
- Decrease in Night Vision
- Disturbance; Vision, Loss
Interventions
- Phentolamine Mesylate Ophthalmic Solution 1%
- Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)
Primary outcomes
- 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.
Countries
United States