Clinical trial NCT04004507: Single Dose Study of Phentolamine Mesylate Eye Drops in Patients With Severe Night Vision Disturbances
Official title: Single Dose Study of Phentolamine Mesylate Eye Drops in Patients With Severe Night Vision Disturbances
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Decrease in Night Vision
Disturbance; Vision, Loss
Keywords: Night Vision Disturbances
NVD
Glare
Halos
Starbursts
Nyxol
Lead sponsor: Ocuphire Pharma, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Ophthalmic Consultants of Long Island
First posted: 2019-07-02
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Contrast Sensitivity
timeFrame: 1 day
Secondary outcomes:
measure: Visual Acuity
timeFrame: 1 day
measure: Self-Reported Vision Quality
timeFrame: 1 day
measure: Pupil Diameter
timeFrame: 1 day
Other outcomes:
Locations:
city: Lynbrook
country: United States
facility: Ophthalmic Consultants of Long Island, NY
state: New York
Study officials:
affiliation: Ophthalmic Consultants of Long Island, NY
name: Marguerite McDonald, MD, FACS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pepose J, Brigell M, Lazar E, Heisel C, Yousif J, Rahmani K, Kolli A, Hwang M, Mitrano C, Lazar A, Charizanis K, Sooch M, McDonald M. A randomized phase 2 clinical trial of phentolamine mesylate eye drops in patients with severe night vision disturbances. BMC Ophthalmol. 2022 Oct 8;22(1):402. doi: 10.1186/s12886-022-02621-6.