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

Decrease in Night Vision Clinical Trial

— SNV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04004507
• Other study ID #: NYX-SNV
• Status: Completed
• Phase: Phase 2
• Start date: August 2007
• Est. completion date: February 2008

Study information

• Verified date: May 2022
• Source: Ocuphire Pharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 2008
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Male or female patients = 18 years of age

2. Currently experiencing severe night vision difficulty as reported subjectively

3. At least two patches below the normal range at any two frequencies in Contrast Sensitivity done under mesopic conditions with glare

4. Improvement in low contrast visual acuity (LCVA) in dim light during illumination of contralateral eye

5. Good general health

6. Written informed consent to participate in this trial

7. Ability to comply with all protocol mandated procedures and to attend all scheduled office visits

Exclusion Criteria:

1. Patients with untreated cataracts grades 1-4

2. Patients who wear contact lenses

3. Less than 5 weeks post-refractive surgery (LASIK or PRK)

4. Less than 5 weeks post intraocular lens insertion

5. Low blood pressure (systolic <120 mm Hg or diastolic <80 mm Hg)

6. A history of heart rate abnormalities

7. Administration of any investigational drug within 30 days of study initiation

8. Use of any eye drops with a pharmacologic effect on the pupil within 7 days of Visit 1

9. Use of any systemic alpha adrenergic antagonists (Appendix 1)

10. Known local or systemic hypersensitivity to adrenergic antagonists

11. For women of childbearing potential: currently pregnant or lactating, or unwilling to use birth control during the study

Related Conditions & MeSH terms

• Decrease in Night Vision
• Disturbance; Vision, Loss

Intervention

Drug:
• Phentolamine Mesylate Ophthalmic Solution 1%
Topical Sterile Ophthalmic Solution

Other:
• Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)
Topical Sterile Ophthalmic Solution

Locations

Country	Name	City	State
United States	Ophthalmic Consultants of Long Island, NY	Lynbrook	New York

Sponsors (2)

Lead Sponsor	Collaborator
Ocuphire Pharma, Inc.	Ophthalmic Consultants of Long Island

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Contrast Sensitivity	Average change in monocular contrast sensitivity scores under mesopic conditions at each of five spatial frequencies with and without glare.; The tests were performed in a darkened room using the Optec 6500 instrument (Stereo Optical) using Slides 5-9 (spatial frequencies 1.5 - 18 cycles per degree), with the distance setting at "far", and with the light setting at "night". Subjects were asked to read each slide from left to right indicating if the lines were tilted to the left, the right or straight up and down until they provided 2 consecutive incorrect responses. The total number of correct responses for each slide was recorded.	1 day
Secondary	Visual Acuity	Average number of letters of improvement in the following parameters: Distance high-contrast visual acuity under mesopic conditions (monocular, measured at 4 meters); Distance high-contrast visual acuity under photopic conditions (monocular, measured at 4 meters); Distance low-contrast visual acuity under mesopic conditions (monocular, measured at 4 meters); Distance low-contrast visual acuity under photopic conditions (monocular, measured at 4 meters)	1 day
Secondary	Self-Reported Vision Quality	Subjective patient evaluations of vision quality at night (% rating their vision as improved)	1 day
Secondary	Pupil Diameter	Average change in pupil diameter	1 day