Trial | NCT04004507  Report issue

Official Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    24
The objectives of this study are:

To assess the effect of ophthalmic phentolamine mesylate in mesopic conditions on the four endpoints:

Contrast sensitivity
Low contrast visual acuity
Wavefront aberrometry
Subjective questionnaire
To assess the safety of ophthalmic phentolamine mesylate
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.
Study Started
Aug 31
2007
Primary Completion
Oct 31
2007
Study Completion
Feb 29
2008
Last Update
Oct 28
2020

Drug Phentolamine Mesylate Ophthalmic Solution 1%

Topical Sterile Ophthalmic Solution

Other Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)

Topical Sterile Ophthalmic Solution

Phentolamine Mesylate Ophthalmic Solution 1% Experimental

1 drop in each eye (QD) for one day.

Phentolamine Mesylate Ophthalmic Solution Vehicle Placebo Comparator

1 drop in each eye (QD) for one day.

Criteria 

Inclusion Criteria:

Male or female patients ≥ 18 years of age
Currently experiencing severe night vision difficulty as reported subjectively
At least two patches below the normal range at any two frequencies in Contrast Sensitivity done under mesopic conditions with glare
Improvement in low contrast visual acuity (LCVA) in dim light during illumination of contralateral eye
Good general health
Written informed consent to participate in this trial
Ability to comply with all protocol mandated procedures and to attend all scheduled office visits

Exclusion Criteria:

Patients with untreated cataracts grades 1-4
Patients who wear contact lenses
Less than 5 weeks post-refractive surgery (LASIK or PRK)
Less than 5 weeks post intraocular lens insertion
Low blood pressure (systolic <120 mm Hg or diastolic <80 mm Hg)
A history of heart rate abnormalities
Administration of any investigational drug within 30 days of study initiation
Use of any eye drops with a pharmacologic effect on the pupil within 7 days of Visit 1
Use of any systemic alpha adrenergic antagonists (Appendix 1)
Known local or systemic hypersensitivity to adrenergic antagonists
For women of childbearing potential: currently pregnant or lactating, or unwilling to use birth control during the study
No Results Posted