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The Safety and Efficacy of Phentolamine Mesylate Ophthalmic Solution in Subjects With Severe Night Vision Disturbances

NCT01703559 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-08-01

No results posted yet for this study

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

Conditions

  • Night Vision Complaints
  • Decrease in Night Vision
  • Disturbance; Vision, Loss

Interventions

DRUG

Phentolamine Mesylate Ophthalmic Solution 1.0%

Phentolamine mesylate (Nyxol) ophthalmic solution 1.0% is a non-selective alpha-1 and alpha-2 adrenergic antagonist

DRUG

Phentolamine Mesylate Ophthalmic Solution 0.5%

Phentolamine mesylate (Nyxol) ophthalmic solution 0.5% is a non-selective alpha-1 and alpha-2 adrenergic antagonist

OTHER

Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)

Placebo (vehicle) is a sterile, isotonic, buffered aqueous solution containing mannitol and sodium acetate

Sponsors & Collaborators

  • Ocuphire Pharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Dennis Swearingen, MD · Celerion

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-09-09
Primary Completion
2012-04-16
Completion
2012-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01703559 on ClinicalTrials.gov