The Safety and Efficacy of Phentolamine Mesylate Ophthalmic Solution in Subjects With Severe Night Vision Disturbances
Completed · Phase 2 · Has a placebo group
Conditions studied: Night Vision Complaints, Decrease in Night Vision, Disturbance; Vision, Loss
In brief
The objectives of this study are: * To evaluate the efficacy of phentolamine mesylate 0.5% and 1.0% ophthalmic solution (Nyxol) in the treatment of night vision complaints, including reduced contrast sensitivity * To evaluate the ocular and systemic safety of phentolamine mesylate 0.5% and 1.0% ophthalmic solution (Nyxol) compared to its vehicle, a sterile, isotonic, buffered aqueous solution containing mannitol and sodium acetate
Key facts
- Study ID
- NCT01703559
- Run by
- Ocuphire Pharma, Inc.
- People needed
- 60
- Starts
- 2011-09-09
- Expected to finish
- 2012-04-30
- Last updated by the study team
- 2019-08-01
Who can join
Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 18 to 45 years of age experiencing severe night vision difficulty (as reported subjectively)
- 0.3 log improvement at least 1 eye using the Holladay Automated Contrast Sensitivity System (HACSS™) test at 2 of 4 spatial frequencies (3, 6, 12, and 18 cycles per degree) under low and high mesopic room illumination with glare
- Photopic visual acuity (corrected or uncorrected) of 20/25 or better
- Able and willing to give informed consent and comply with all protocol-mandated procedures
You may not qualify if…
- Cataracts (nuclear sclerosis or anterior subcapsular) of 1+ or greater
- Contact lens wear within 4 weeks of enrollment
- Ocular trauma within the past 6 months, or ocular surgery or laser treatment within the past 3 months
- Refractive surgery or cataract surgery in either eye
- Use of ocular medication within 4 weeks of Visit 1
- Clinically significant ocular disease (e.g., corneal edema, uveitis, severe keratoconjunctivitis sicca, glaucoma, retinal degenerative disease) which might interfere with the study
- Any abnormality preventing reliable applanation tonometry of either eye
- Central corneal thickness greater than 600 µ
- Known hypersensitivity or contraindication to PM, or any component of the formulation, or to topical anesthetics.
- Contraindications to phentolamine (including history of myocardial infarction, cerebrovascular spasm, cerebrovascular occlusion, coronary insufficiency, angina, or other evidence suggestive of coronary artery disease)
- Low blood pressure: systolic < 100 mm Hg or diastolic < 60 mm Hg
- A history of heart rate abnormalities, such as tachycardia or arrhythmias.
- Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia gravis, hepatic, renal, cardiovascular, or endocrine disorders) which might interfere with the study
- Use of any systemic alpha adrenergic antagonists up to 4 weeks prior to screening or during the study
- Changes of systemic medication that could have a substantial effect on ocular autonomic pupil tone 4 weeks prior to screening, or anticipated during the study
- Participation in any investigational study within the past 30 days
- Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control. An adult woman is considered to be of childbearing potential unless she is 1 year post-menopausal or 3 months post-surgical sterilization. All females of childbearing potential must have a negative serum pregnancy test result at the screening examination and must not intend to become pregnant during the study
Where it is running
- Celerion — Phoenix, Arizona, United States
Full record on ClinicalTrials.gov
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