Phase 2
N=24
Single Dose Study of Phentolamine Mesylate Eye Drops in Patients With Severe Night Vision Disturbances
Decrease in Night Vision · Disturbance; Vision, Loss
Bottom Line
View on ClinicalTrials.gov: NCT04004507 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcome: Primary: Contrast Sensitivity — 0.6; 0.8; 0.9; 0.7 Patches
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Phentolamine Mesylate Ophthalmic Solution 1% (Drug); Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo) (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ocuphire Pharma, Inc.
- Primary completion
- Oct 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Contrast Sensitivity |
0.6; 0.8; 0.9; 0.7; 1.4; 0.1 | — |
| SECONDARY Visual Acuity |
6.5; 1.1; 3.8; 0.1; 8.0; 3.1 | — |
| SECONDARY Self-Reported Vision Quality |
69; 75 | — |
| SECONDARY Pupil Diameter |
-1.3; -0.2 | — |
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
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT04004507). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.