The Safety and Efficacy of Phentolamine Mesylate Ophthalmic Solution in Subjects With Severe Night Vision Disturbances

NCT01703559 | Completed Phase 2 FDA Drug

• 1 other identifier: OP-NYX-01a2
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Night Vision Complaints; Decrease in Night Vision; Disturbance; Vision, Loss

Keywords

Glare; Starbursts; Halos; Reduced Contrast Sensitivity; Night Vision Disturbances; NVD; NVDs

Outcome Measures

Primary Outcomes (1)

• Proportion of Eyes With ≥ 0.3 Log Increase in Mesopic Contrast Sensitivities for at Least 2 HACSS Frequencies

  Proportion of eyes with an increase ≥ 0.3 log (2 or more patches) in mesopic contrast sensitivity with glare at one or more frequencies at 1.5, 3, 6, 12, and 18 cycles per degree, measured with the HACSS methodology (categorical analysis)

  Days 1, 4, 8, 15, and 32

Secondary Outcomes (5)

• Pupil Diameter - Change from Day 1 Pre-Dose Baseline

  Day 1 post-dose and Days 4, 8, and 15

• Mesopic Contrast Sensitivity with Glare at 1 or More Frequencies at 1.5, 3, 6, 12, and 18 Cycles Per Degree, Measured with the HACSS Methodology - Change from Day 1 Pre-Dose Baseline

  Day 1 post-dose and Days 4, 8, and 15

• Mesopic Contrast Sensitivity without Glare at 1 or More Frequencies at 1.5, 3, 6, 12, and 18 Cycles Per Degree, Measured with the HACSS Methodology - Change from Day 1 Pre-Dose Baseline

  Day 1 post-dose and Days 4, 8, and 15

• Mesopic Distance High Contrast Visual Acuity (HCVA), Measured with Electronic Early Treatment Diabetic Retinopathy Study (eETDRS) Charts - Change from Day 1 Pre-Dose Baseline

  Day 1 post-dose and Days 4, 8, and 15

• Mesopic Distance Low Contrast Visual Acuity (LCVA), Measured with eETDRS Charts - Change from Day 1 Pre-Dose Baseline

  Day 1 post-dose and Days 4, 8, and 15

Other Outcomes (1)

• Subjective Evaluations of Vision (NEI Vision Function) - Change from Day 15

  Day 32

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Administered once daily in both eyes for 15 days

Other: Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)

Phentolamine Mesylate Ophthalmic Solution 0.5%

EXPERIMENTAL

Administered once daily in both eyes for 15 days

Drug: Phentolamine Mesylate Ophthalmic Solution 0.5%

Phentolamine Mesylate Ophthalmic Solution 1.0%

EXPERIMENTAL

Administered once daily in both eyes for 15 days

Drug: Phentolamine Mesylate Ophthalmic Solution 1.0%

Interventions

Phentolamine Mesylate Ophthalmic Solution 1.0% DRUG

Phentolamine mesylate (Nyxol) ophthalmic solution 1.0% is a non-selective alpha-1 and alpha-2 adrenergic antagonist

Also known as: Nyxol®, Nyxol

Phentolamine Mesylate Ophthalmic Solution 1.0%

Phentolamine Mesylate Ophthalmic Solution 0.5% DRUG

Phentolamine mesylate (Nyxol) ophthalmic solution 0.5% is a non-selective alpha-1 and alpha-2 adrenergic antagonist

Also known as: Nyxol®, Nyxol

Phentolamine Mesylate Ophthalmic Solution 0.5%

Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo) OTHER

Placebo (vehicle) is a sterile, isotonic, buffered aqueous solution containing mannitol and sodium acetate

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• to 45 years of age experiencing severe night vision difficulty (as reported subjectively)
• 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

Sponsors & Collaborators

• Ocuphire Pharma, Inc.: lead

Study Sites (1)

Celerion

Phoenix, Arizona, 67230, United States

Location

Study Officials

• Dennis Swearingen, MD

  Celerion

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2012
• First Posted: October 10, 2012
• Study Start: September 9, 2011
• Primary Completion: April 16, 2012
• Study Completion: April 30, 2012
• Last Updated: August 1, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)