Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : August 1, 2019
Sponsor:
Information provided by (Responsible Party):
Ocuphire Pharma, Inc.

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

Condition or disease Intervention/treatment Phase
Decrease in Night Vision Disturbance; Vision, Loss Drug: Phentolamine Mesylate Ophthalmic Solution 1% Other: Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo) Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Single Dose Study of Phentolamine Mesylate Eye Drops in Patients With Severe Night Vision Disturbances
Actual Study Start Date : August 2007
Actual Primary Completion Date : October 2007
Actual Study Completion Date : February 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Phentolamine Mesylate Ophthalmic Solution 1%
1 drop in each eye (QD) for one day.
Drug: Phentolamine Mesylate Ophthalmic Solution 1%
Topical Sterile Ophthalmic Solution

Placebo Comparator: Phentolamine Mesylate Ophthalmic Solution Vehicle
1 drop in each eye (QD) for one day.
Other: Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)
Topical Sterile Ophthalmic Solution




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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)

  2. Wavefront Aberrometry [ Time Frame: 1 day ]
    Wavefront aberrometry under mesopic conditions

  3. Self-Reported Vision Quality [ Time Frame: 1 day ]
    Subjective patient evaluations of vision quality

  4. Pupil Diameter [ Time Frame: 1 day ]
    Average change in pupil diameter



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04004507


Locations
Layout table for location information
United States, New York
Ophthalmic Consultants of Long Island, NY
Lynbrook, New York, United States, 11563
Sponsors and Collaborators
Ocuphire Pharma, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Marguerite McDonald, MD, FACS Ophthalmic Consultants of Long Island, NY

Layout table for additonal information
Responsible Party: Ocuphire Pharma, Inc.
ClinicalTrials.gov Identifier: NCT04004507     History of Changes
Other Study ID Numbers: NYX-SNV
First Posted: July 2, 2019    Key Record Dates
Last Update Posted: August 1, 2019
Last Verified: July 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ocuphire Pharma, Inc.:
Night Vision Disturbances
NVD
Glare
Halos
Starbursts
Nyxol
Additional relevant MeSH terms:
Layout table for MeSH terms
Phentolamine
Ophthalmic Solutions
Pharmaceutical Solutions
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antihypertensive Agents