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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01703559
Recruitment Status : Completed
First Posted : October 10, 2012
Last Update Posted : August 1, 2019
Sponsor:
Information provided by (Responsible Party):
Ocuphire Pharma, Inc.

Tracking Information
First Submitted Date  ICMJE May 18, 2012
First Posted Date  ICMJE October 10, 2012
Last Update Posted Date August 1, 2019
Actual Study Start Date  ICMJE September 9, 2011
Actual Primary Completion Date April 16, 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 16, 2019)
Proportion of Eyes With ≥ 0.3 Log Increase in Mesopic Contrast Sensitivities for at Least 2 HACSS Frequencies [ Time Frame: Days 1, 4, 8, 15, and 32 ]
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)
Original Primary Outcome Measures  ICMJE
 (submitted: October 9, 2012)
Double-masked Parallel Evaluation of the Safety and Efficacy of Phentolamine Mesylate Ophthalmic Solution... [ Time Frame: 15 days ]
The primary efficacy endpoint will be the proportion of subjects with an increase of at least 0.3 log in mesopic contrast sensitivity with glare at two or more frequencies at 1.5, 3, 6, 12, and 18 cycles per degree, measured with the Holladay Automated Contrast Sensitivity System (HACSS™) methodology.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2019)
  • Pupil Diameter - Change from Day 1 Pre-Dose Baseline [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Day 1 post-dose and Days 4, 8, and 15 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2012)
  • Double-masked Parallel Evaluation of the Safety and Efficacy of Phentolamine Mesylate Ophthalmic Solution ... [ Time Frame: 2 hours post dose, Days 1, 4, 8, and 15 ]
    Mesopic contrast sensitivity with glare - continuous analysis
  • Double-masked Parallel Evaluation of the Safety and Efficacy of Phentolamine Mesylate Ophthalmic Solution [ Time Frame: 2 hours post dose, Days 1, 4, 8, and 15 ]
    Mesopic contrast sensitivity without glare
  • Double-masked Parallel Evaluation of the Safety and Efficacy of Phentolamine Mesylate Ophthalmic Solution [ Time Frame: 2 hours post dose, Days 1, 4, 8, and 15 ]
    Mesopic low contrast visual acuity
  • Double-masked Parallel Evaluation of the Safety and Efficacy of Phentolamine Mesylate Ophthalmic Solution [ Time Frame: 2 hours post dose, Days 1, 4, 8, and 15 ]
    Mesopic high contrast visual acuity
  • Double-masked Parallel Evaluation of the Safety and Efficacy of Phentolamine Mesylate Ophthalmic Solution [ Time Frame: 2 hours post dose, Days 1, 4, 8, and 15 ]
    Photopic high contrast visual acuity
  • Double-masked Parallel Evaluation of the Safety and Efficacy of Phentolamine Mesylate Ophthalmic Solution [ Time Frame: 2 hours post dose, Days 1, 4, 8, and 15 ]
    Pupil diameter
  • Double-masked Parallel Evaluation of the Safety and Efficacy of Phentolamine Mesylate Ophthalmic Solution [ Time Frame: 2 hours post dose, Days 1, 4, 8, and 15 ]
    Ocular hyperemia
Current Other Pre-specified Outcome Measures
 (submitted: July 16, 2019)
Subjective Evaluations of Vision (NEI Vision Function) - Change from Day 15 [ Time Frame: Day 32 ]
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Safety and Efficacy of Phentolamine Mesylate Ophthalmic Solution in Subjects With Severe Night Vision Disturbances
Official Title  ICMJE Double-Masked Parallel Evaluation of the Safety and Efficacy of Phentolamine Mesylate Ophthalmic Solution in Subjects With Severe Night Vision Disturbances
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
Detailed Description

Randomized, double-masked, multiple dose Phase 2 parallel evaluation of the safety and efficacy of phentolamine mesylate (PM) ophthalmic solution in 60 subjects with severe night vision complaints, evaluating ocular and systemic safety and efficacy following administration of phentolamine mesylate (.05% or 1%) in both eyes for 15 days.

Subjects were randomized into three groups with a 1:1:1 randomization. The groups received either (1) phentolamine mesylate ophthalmic solution 0.5%, (2) phentolamine mesylate ophthalmic solution 1.0%, or (3) placebo, once daily (QD) for 15 days. The treatment period was 15 days, plus 6 additional days over the next 14 days. After 15 days, all subjects were given the opportunity to receive an additional 6 doses of 1.0% phentolamine mesylate to be taken once daily as needed over the next two weeks. There was a post-dosing follow-up evaluation 7 days after the last dose. Study participants completed a night vision questionnaire at pre-treatment and after 15 and 29 days.

Efficacy evaluations included contrast sensitivity (mesopic, with and without glare), mesopic distance high contrast visual acuity (HCVA) and mesopic distance low contrast visual acuity (LCVA). Safety evaluations included photopic distance HCVA, a complete ophthalmic examination and measurement of heart rate and blood pressure.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Night Vision Complaints
  • Decrease in Night Vision
  • Disturbance; Vision, Loss
Intervention  ICMJE
  • Drug: Phentolamine Mesylate Ophthalmic Solution 1.0%
    Phentolamine mesylate (Nyxol) ophthalmic solution 1.0% is a non-selective alpha-1 and alpha-2 adrenergic antagonist
    Other Names:
    • Nyxol®
    • Nyxol
  • Drug: Phentolamine Mesylate Ophthalmic Solution 0.5%
    Phentolamine mesylate (Nyxol) ophthalmic solution 0.5% is a non-selective alpha-1 and alpha-2 adrenergic antagonist
    Other Names:
    • Nyxol®
    • Nyxol
  • Other: Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)
    Placebo (vehicle) is a sterile, isotonic, buffered aqueous solution containing mannitol and sodium acetate
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Administered once daily in both eyes for 15 days
    Intervention: Other: Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)
  • Experimental: Phentolamine Mesylate Ophthalmic Solution 0.5%
    Administered once daily in both eyes for 15 days
    Intervention: Drug: Phentolamine Mesylate Ophthalmic Solution 0.5%
  • Experimental: Phentolamine Mesylate Ophthalmic Solution 1.0%
    Administered once daily in both eyes for 15 days
    Intervention: Drug: Phentolamine Mesylate Ophthalmic Solution 1.0%
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 9, 2012)
60
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 30, 2012
Actual Primary Completion Date April 16, 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. 18 to 45 years of age experiencing severe night vision difficulty (as reported subjectively)
  2. 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
  3. Photopic visual acuity (corrected or uncorrected) of 20/25 or better
  4. Able and willing to give informed consent and comply with all protocol-mandated procedures

Exclusion Criteria:

  1. Cataracts (nuclear sclerosis or anterior subcapsular) of 1+ or greater
  2. Contact lens wear within 4 weeks of enrollment
  3. Ocular trauma within the past 6 months, or ocular surgery or laser treatment within the past 3 months
  4. Refractive surgery or cataract surgery in either eye
  5. Use of ocular medication within 4 weeks of Visit 1
  6. Clinically significant ocular disease (e.g., corneal edema, uveitis, severe keratoconjunctivitis sicca, glaucoma, retinal degenerative disease) which might interfere with the study
  7. Any abnormality preventing reliable applanation tonometry of either eye
  8. Central corneal thickness greater than 600 µ
  9. Known hypersensitivity or contraindication to PM, or any component of the formulation, or to topical anesthetics.
  10. Contraindications to phentolamine (including history of myocardial infarction, cerebrovascular spasm, cerebrovascular occlusion, coronary insufficiency, angina, or other evidence suggestive of coronary artery disease)
  11. Low blood pressure: systolic < 100 mm Hg or diastolic < 60 mm Hg
  12. A history of heart rate abnormalities, such as tachycardia or arrhythmias.
  13. Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia gravis, hepatic, renal, cardiovascular, or endocrine disorders) which might interfere with the study
  14. Use of any systemic alpha adrenergic antagonists up to 4 weeks prior to screening or during the study
  15. 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
  16. Participation in any investigational study within the past 30 days
  17. 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01703559
Other Study ID Numbers  ICMJE OP-NYX-01a2
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ocuphire Pharma, Inc.
Study Sponsor  ICMJE Ocuphire Pharma, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dennis Swearingen, MD Celerion
PRS Account Ocuphire Pharma, Inc.
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP