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Single Dose Study of Phentolamine Mesylate Eye Drops in Patients With Severe Night Vision Disturbances (SNV)

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: NCT04004507
Recruitment Status : Completed
First Posted : July 2, 2019
Last Update Posted : October 28, 2020
Sponsor:
Collaborator:
Ophthalmic Consultants of Long Island
Information provided by (Responsible Party):
Ocuphire Pharma, Inc.

Tracking Information
First Submitted Date  ICMJE June 28, 2019
First Posted Date  ICMJE July 2, 2019
Last Update Posted Date October 28, 2020
Actual Study Start Date  ICMJE August 2007
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 28, 2019)
Contrast Sensitivity [ Time Frame: 1 day ]
Average change in monocular contrast sensitivity scores under mesopic conditions at each of five spatial frequencies with and without glare
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2019)
  • Visual Acuity [ Time Frame: 1 day ]
    Average number of letters of improvement in the following parameters:
    1. Distance high-contrast visual acuity under mesopic conditions (monocular, measured at 4 meters)
    2. Distance high-contrast visual acuity under photopic conditions (monocular, measured at 4 meters)
    3. Distance low-contrast visual acuity under mesopic conditions (monocular, measured at 4 meters)
    4. Distance low-contrast visual acuity under photopic conditions (monocular, measured at 4 meters)
  • Wavefront Aberrometry [ Time Frame: 1 day ]
    Wavefront aberrometry under mesopic conditions
  • Self-Reported Vision Quality [ Time Frame: 1 day ]
    Subjective patient evaluations of vision quality
  • Pupil Diameter [ Time Frame: 1 day ]
    Average change in pupil diameter
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Single Dose Study of Phentolamine Mesylate Eye Drops in Patients With Severe Night Vision Disturbances
Official Title  ICMJE Single Dose Study of Phentolamine Mesylate Eye Drops in Patients With Severe Night Vision Disturbances
Brief 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
Detailed Description Double-masked, placebo-controlled, single-dose Phase 2 study in 24 patients experiencing severe night vision difficulties to evaluate ocular and systemic safety and efficacy following administration of one drop of phentolamine mesylate 1.0% QD in each eye for 1 day.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Decrease in Night Vision
  • Disturbance; Vision, Loss
Intervention  ICMJE
  • Drug: Phentolamine Mesylate Ophthalmic Solution 1%
    Topical Sterile Ophthalmic Solution
  • Other: Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)
    Topical Sterile Ophthalmic Solution
Study Arms  ICMJE
  • Experimental: Phentolamine Mesylate Ophthalmic Solution 1%
    1 drop in each eye (QD) for one day.
    Intervention: Drug: Phentolamine Mesylate Ophthalmic Solution 1%
  • Placebo Comparator: Phentolamine Mesylate Ophthalmic Solution Vehicle
    1 drop in each eye (QD) for one day.
    Intervention: Other: Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)
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: June 28, 2019)
24
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2008
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male or female patients ≥ 18 years of age
  2. Currently experiencing severe night vision difficulty as reported subjectively
  3. At least two patches below the normal range at any two frequencies in Contrast Sensitivity done under mesopic conditions with glare
  4. Improvement in low contrast visual acuity (LCVA) in dim light during illumination of contralateral eye
  5. Good general health
  6. Written informed consent to participate in this trial
  7. Ability to comply with all protocol mandated procedures and to attend all scheduled office visits

Exclusion Criteria:

  1. Patients with untreated cataracts grades 1-4
  2. Patients who wear contact lenses
  3. Less than 5 weeks post-refractive surgery (LASIK or PRK)
  4. Less than 5 weeks post intraocular lens insertion
  5. Low blood pressure (systolic <120 mm Hg or diastolic <80 mm Hg)
  6. A history of heart rate abnormalities
  7. Administration of any investigational drug within 30 days of study initiation
  8. Use of any eye drops with a pharmacologic effect on the pupil within 7 days of Visit 1
  9. Use of any systemic alpha adrenergic antagonists (Appendix 1)
  10. Known local or systemic hypersensitivity to adrenergic antagonists
  11. For women of childbearing potential: currently pregnant or lactating, or unwilling to use birth control during the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
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 NCT04004507
Other Study ID Numbers  ICMJE NYX-SNV
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 Not Provided
Responsible Party Ocuphire Pharma, Inc.
Study Sponsor  ICMJE Ocuphire Pharma, Inc.
Collaborators  ICMJE Ophthalmic Consultants of Long Island
Investigators  ICMJE
Principal Investigator: Marguerite McDonald, MD, FACS Ophthalmic Consultants of Long Island, NY
PRS Account Ocuphire Pharma, Inc.
Verification Date October 2020

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