Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.

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

Condition or disease Intervention/treatment Phase
Night Vision Complaints Decrease in Night Vision Disturbance; Vision, Loss Drug: Phentolamine Mesylate Ophthalmic Solution 1.0% Drug: Phentolamine Mesylate Ophthalmic Solution 0.5% Other: Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo) Phase 2

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-Masked Parallel Evaluation of the Safety and Efficacy of Phentolamine Mesylate Ophthalmic Solution in Subjects With Severe Night Vision Disturbances
Actual Study Start Date : September 9, 2011
Actual Primary Completion Date : April 16, 2012
Actual Study Completion Date : April 30, 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Administered once daily in both eyes for 15 days
Other: Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)
Placebo (vehicle) is a sterile, isotonic, buffered aqueous solution containing mannitol and sodium acetate

Experimental: Phentolamine Mesylate Ophthalmic Solution 0.5%
Administered once daily in both eyes for 15 days
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

Experimental: Phentolamine Mesylate Ophthalmic Solution 1.0%
Administered once daily in both eyes for 15 days
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




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Pupil Diameter - Change from Day 1 Pre-Dose Baseline [ Time Frame: Day 1 post-dose and Days 4, 8, and 15 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]

Other Outcome Measures:
  1. Subjective Evaluations of Vision (NEI Vision Function) - Change from Day 15 [ Time Frame: Day 32 ]


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 to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT01703559


Locations
Layout table for location information
United States, Arizona
Celerion
Phoenix, Arizona, United States, 67230
Sponsors and Collaborators
Ocuphire Pharma, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Dennis Swearingen, MD Celerion

Layout table for additonal information
Responsible Party: Ocuphire Pharma, Inc.
ClinicalTrials.gov Identifier: NCT01703559     History of Changes
Other Study ID Numbers: OP-NYX-01a2
First Posted: October 10, 2012    Key Record Dates
Last Update Posted: August 1, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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.:
Glare
Starbursts
Halos
Reduced Contrast Sensitivity
Night Vision Disturbances
NVD
NVDs
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