Single Dose Study of Phentolamine Mesylate Eye Drops in Patients With Severe Night Vision Disturb… (NCT04004507) | Clinical Trial Compass
CompletedPhase 2
Single Dose Study of Phentolamine Mesylate Eye Drops in Patients With Severe Night Vision Disturbances
United States24 participantsStarted 2007-08
Plain-language 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
Who can participate
Age range18 Years – 80 Years
SexALL
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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