Conditions: Decrease in Night Vision Disturbance; Vision, Loss
Keywords: Night Vision Disturbances NVD Glare Halos Starbursts Nyxol
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 24
Healthy volunteers: no

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.

Arms:
arm 1: 1 drop in each eye (QD) for one day. arm 2: 1 drop in each eye (QD) for one day.

Interventions: intervention 1: Phentolamine Mesylate Ophthalmic Solution 1% intervention 2: Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)
Intervention descriptions: intervention 1: Topical Sterile Ophthalmic Solution intervention 2: Topical Sterile Ophthalmic Solution

Protocol document: