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Single Dose Study of Phentolamine Mesylate Eye Drops in Patients With Severe Night Vision Disturbances

NCT04004507 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-02-15

Study results available
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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

Conditions

  • Decrease in Night Vision
  • Disturbance; Vision, Loss

Interventions

DRUG

Phentolamine Mesylate Ophthalmic Solution 1%

Topical Sterile Ophthalmic Solution

OTHER

Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)

Topical Sterile Ophthalmic Solution

Sponsors & Collaborators

  • Ophthalmic Consultants of Long Island

    collaborator OTHER

  • Ocuphire Pharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Marguerite McDonald, MD, FACS · Ophthalmic Consultants of Long Island, NY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2007-10-31
Completion
2008-02-29
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 NCT04004507 on ClinicalTrials.gov