The Safety and Efficacy of Phentolamine Mesylate Ophthalmic Solution in Subjects With Severe Night Vision Disturbances
Condition: Night Vision Complaints; Decrease in Night Vision; Disturbance; Vision, Loss
Study type: Interventional
Phase: Phase 2

Summary: 
      The objectives of this study are:

        -  To evaluate the efficacy of phentolamine mesylate 0.5% and 1.0% ophthalmic solution
           (Nyxol) in the treatment of night vision complaints, including reduced contrast
           sensitivity

        -  To evaluate the ocular and systemic safety of phentolamine mesylate 0.5% and 1.0%
           ophthalmic solution (Nyxol) compared to its vehicle, a sterile, isotonic, buffered
           aqueous solution containing mannitol and sodium acetate
    

Detailed description: 
      Randomized, double-masked, multiple dose Phase 2 parallel evaluation of the safety and
      efficacy of phentolamine mesylate (PM) ophthalmic solution in 60 subjects with severe night
      vision complaints, evaluating ocular and systemic safety and efficacy following
      administration of phentolamine mesylate (.05% or 1%) in both eyes for 15 days.

      Subjects were randomized into three groups with a 1:1:1 randomization. The groups received
      either (1) phentolamine mesylate ophthalmic solution 0.5%, (2) phentolamine mesylate
      ophthalmic solution 1.0%, or (3) placebo, once daily (QD) for 15 days. The treatment period
      was 15 days, plus 6 additional days over the next 14 days. After 15 days, all subjects were
      given the opportunity to receive an additional 6 doses of 1.0% phentolamine mesylate to be
      taken once daily as needed over the next two weeks. There was a post-dosing follow-up
      evaluation 7 days after the last dose. Study participants completed a night vision
      questionnaire at pre-treatment and after 15 and 29 days.

      Efficacy evaluations included contrast sensitivity (mesopic, with and without glare), mesopic
      distance high contrast visual acuity (HCVA) and mesopic distance low contrast visual acuity
      (LCVA). Safety evaluations included photopic distance HCVA, a complete ophthalmic examination
      and measurement of heart rate and blood pressure.
    

Intervention name(s): Phentolamine Mesylate Ophthalmic Solution 1.0%; Phentolamine Mesylate Ophthalmic Solution 0.5%; Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)
Intervention type(s): Drug; Drug; Other
Intervention description(s): Phentolamine mesylate (Nyxol) ophthalmic solution 1.0% is a non-selective alpha-1 and alpha-2 adrenergic antagonist; Phentolamine mesylate (Nyxol) ophthalmic solution 0.5% is a non-selective alpha-1 and alpha-2 adrenergic antagonist; Placebo (vehicle) is a sterile, isotonic, buffered aqueous solution containing mannitol and sodium acetate
Other intervention name(s): Nyxol®; Nyxol; Nyxol®; Nyxol
Intervention MeSH terms: Phentolamine; Pharmaceutical Solutions; Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Glare; Starbursts; Halos; Reduced Contrast Sensitivity; Night Vision Disturbances; NVD; NVDs