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Safety and Efficacy of Ophthalmic Phentolamine Mesylate to Reverse Pharmacologically Induced Mydriasis

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ClinicalTrials.gov Identifier: NCT04024891
Recruitment Status : Completed
First Posted : July 18, 2019
Last Update Posted : October 14, 2019
Sponsor:
Information provided by (Responsible Party):
Ocuphire Pharma, Inc.

Brief Summary:

The objectives of this study are:

  • To evaluate the efficacy of Nyxol (phentolamine mesylate ophthalmic solution 1%) to expedite the reversal of pharmacologic mydriasis
  • To evaluate the safety of Nyxol
  • To evaluate the effect of Lumify® to suppress conjunctival hyperemia (redness) potentially associated with administration of Nyxol

Condition or disease Intervention/treatment Phase
Mydriasis Dilation Drug: Phentolamine Mesylate Ophthalmic Solution 1% Other: Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo) Phase 2

Detailed Description:

Randomized, 2-arm cross-over, double-masked Phase 2b study in approximately 32 healthy subjects, evaluating safety and efficacy of Nyxol in subjects with pharmacologically induced mydriasis.

At the first visit subjects will be screened for study eligibility.

After screening, eligible subjects will be randomized 1:1 to one of the two treatment sequences:

Treatment sequence 1: Placebo (Visit 1), Nyxol (Visit 2).

Treatment sequence 2: Nyxol (Visit 1), Placebo (Visit 2).

Randomization will be stratified by mydriatic agent (2.5% phenylephrine or 1% tropicamide). Approximately one half of the randomized subjects will receive 2.5% phenylephrine and one half will receive 1% tropicamide. Subjects will receive their mydriatic agent 1 hour before treatment. Each subject will receive the same mydriatic agent throughout the study.

At each visit, pupil diameter (PD), accommodation, near and distance visual acuity (VA) and redness in each eye will be measured before (-1 hour/baseline) and 1 hour after (maximum/0 minutes) the mydriatic agent instillation in each eye (i.e., right before the study treatment is administered), and at 30 minutes, 1 hour, 2 hours, 4 hours and 6 hours after treatment dosing.

As needed, two hours post treatment, subjects may request the administration of Lumify® in the non-study eye.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Cross-Over, Double-Masked, Placebo-Controlled Study of the Safety and Efficacy of Phentolamine Mesylate Ophthalmic Solution to Reverse Pharmacologically Induced Mydriasis in Normal Healthy Subjects
Actual Study Start Date : August 13, 2019
Actual Primary Completion Date : September 17, 2019
Actual Study Completion Date : September 17, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Phentolamine Mesylate Ophthalmic Solution 1%
1 drop in each eye, 1 hour post medically-induced mydriasis
Drug: Phentolamine Mesylate Ophthalmic Solution 1%
1% phentolamine mesylate ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist
Other Names:
  • Nyxol®
  • Nyxol

Placebo Comparator: Phentolamine Mesylate Ophthalmic Solution Vehicle
1 drop in each eye, 1 hour post medically-induced mydriasis
Other: Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)
Topical Sterile Ophthalmic Solution




Primary Outcome Measures :
  1. Pupil Diameter (Change from Max) [ Time Frame: 2 hours ]
    Change in pharmacologically-induced mydriatic (maximum) pupil diameter at 2 hours post-treatment in the study eye.


Secondary Outcome Measures :
  1. Pupil Diameter (Change from Max) [ Time Frame: 30 min, 1 hours, 4 hours, 6 hours ]
    Change in pharmacologically-induced mydriatic (maximum) pupil diameter at remaining timepoints (30 min, 1 hours, 4 hours, 6 hours)

  2. Accommodation Measured by the Near Point Rule (Diopters) (Change from Baseline) [ Time Frame: 0 min, 30 min, 1 hour, 2 hours, 4 hours, 6 hours ]

    Change from baseline (-1 hour) in accommodation at each timepoint (0 min, 30 min, 1 hour, 2 hours, 4 hours, 6 hours)

    Worsening of accommodation is defined as an amplitude decrease of greater than 1 diopter compared to baseline


  3. Best Corrected Distance Visual Acuity (BCDVA) Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Light Box Chart (Letters) at 4 Meters (Change from Baseline) [ Time Frame: 0 min, 30 min, 1 hour, 2 hours, 4 hours, 6 hours ]
    Change from baseline (-1 hour) in BCDVA at each timepoint (0 min, 30 min, 1 hour, 2 hours, 4 hours, 6 hours)

  4. Distance-Corrected Near Visual Acuity (DCNVA) Measured by Standard Reading Card (Original Series Sloan Letter ETDRS Card at 16 Inches, LogMAR Units) (Change from Baseline) [ Time Frame: 0 min, 30 min, 1 hour, 2 hours, 4 hours, 6 hours ]
    Change from baseline (-1 hour) in DCNVA at each timepoint (0 min, 30 min, 1 hour, 2 hours, 4 hours, 6 hours)

  5. Conjunctival Hyperemia (Eye Redness) Assessed Visually with the Brien Holden Vision Institute (formerly Corneal and Contact Lens Research Unit, or CCLRU) Bulbar Redness Scale (0-3) (Change from Baseline) [ Time Frame: 0 min, 30 min, 1 hour, 2 hours, 4 hours, 6 hours ]
    Change from baseline (-1 hour) in conjunctival hyperemia at each timepoint (0 min, 30 min, 1 hour, 2 hours, 4 hours, 6 hours), for study eye and non-study eye; in all subjects, in subjects taking Lumify®, and in subjects not taking Lumify®



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Males or females ≥ 18 and ≤ 45 years of age with brown irides (irises) only
  2. Otherwise healthy and well controlled subjects
  3. Able to comply with all protocol mandated procedures and to attend all scheduled office visits
  4. Willing to give written informed consent to participate in this study

Exclusion Criteria

  1. Clinically significant ocular disease as deemed by the Investigator (e.g., cataract, glaucoma, corneal edema, uveitis, severe keratoconjunctivitis sicca) that might interfere with the study
  2. Unwilling or unable to discontinue use of contact lenses during treatment visits
  3. Ocular trauma, ocular surgery or non-refractive laser treatment within the 6 months prior to screening
  4. Ocular medication of any kind within 30 days of screening, with the exception of a) lid scrubs (which may have been used prior to, but not after screening) or b) lubricating drops for dry eye (preservative-free artificial tears), which may be used in between the study treatment days
  5. Recent or current evidence of ocular infection or inflammation. Current evidence of clinically significant blepharitis, conjunctivitis, or a history of herpes simplex or herpes zoster keratitis at screening
  6. History of diabetic retinopathy
  7. Closed or very narrow angles that in the Investigator's opinion are potentially occludable if the subject's pupil is dilated
  8. History of any traumatic (surgical or nonsurgical) or non-traumatic condition affecting the pupil or iris (e.g., irregularly shaped pupil, neurogenic pupil disorder, iris atrophy, iridotomy)
  9. Known allergy or contraindication to any component of the mydriatic agents or the vehicle formulation
  10. Known hypersensitivity or contraindication to α- and/or β-adrenoceptor antagonists (e.g., chronic obstructive pulmonary disease or bronchial asthma; abnormally low blood pressure (BP) or heart rate (HR); second- or third-degree heart blockage or Congestive Heart Failure (CHF); severe diabetes)
  11. Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia gravis, cancer, hepatic, renal, endocrine or cardiovascular disorders) that might interfere with the study
  12. Initiation of treatment with or any changes to the current dosage, drug or regimen of any topical or systemic adrenergic or cholinergic drugs up to 7 days prior to screening, or during the study
  13. Participation in any investigational study within 30 days prior to screening
  14. Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control. Acceptable methods include the use of at least one of the following: intrauterine device (IUD), hormonal (oral, injection, patch, implant, ring), barrier with spermicide (condom, diaphragm), or abstinence. An adult woman is considered to be of childbearing potential unless she is 1 year postmenopausal or 3 months post-surgical sterilization. All females of childbearing potential must have a negative urine pregnancy test result at Visit 1/Screening and Visit 2 examinations and must intend to not become pregnant during the study
  15. Resting heart rate (HR) outside the normal range (50-110 beats per minute) at the Screening Visit. HR may be repeated only once if outside the normal range following at least a 5-minute rest period in the sitting position
  16. Hypertension with resting diastolic BP > 105 mmHg or systolic BP > 160 mmHg at the Screening Visit. BP may be repeated only once if outside the specified range following at least a 5-minute rest period in the sitting position

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): NCT04024891


Locations
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United States, Kansas
Kannar Eye Care
Pittsburg, Kansas, United States, 66762
United States, Kentucky
Kentucky Eye Institute
Lexington, Kentucky, United States, 40517
United States, Ohio
Athens Eye Care
Athens, Ohio, United States, 45701
United States, Rhode Island
West Bay Eye Associates
Warwick, Rhode Island, United States, 02888
Sponsors and Collaborators
Ocuphire Pharma, Inc.

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Responsible Party: Ocuphire Pharma, Inc.
ClinicalTrials.gov Identifier: NCT04024891     History of Changes
Other Study ID Numbers: OPI-NYXRM-201 (MIRA-1)
First Posted: July 18, 2019    Key Record Dates
Last Update Posted: October 14, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ocuphire Pharma, Inc.:
Nyxol
Pharmacologically Induced Mydriasis
Dilation
Additional relevant MeSH terms:
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Mydriasis
Dilatation, Pathologic
Pathological Conditions, Anatomical
Pupil Disorders
Eye Diseases
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