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Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04620213
Recruitment Status : Recruiting
First Posted : November 6, 2020
Last Update Posted : November 18, 2020
Sponsor:
Information provided by (Responsible Party):
Ocuphire Pharma, Inc.

Brief Summary:

The objectives of this study are:

  • To evaluate the efficacy of Nyxol to expedite the reversal of pharmacologically-induced mydriasis across multiple mydriatic agents with an emphasis on phenylephrine
  • To evaluate the efficacy of Nyxol to return subjects to baseline accommodation after worsening (with cycloplegic agents tropicamide and Paremyd)
  • To evaluate the safety of Nyxol
  • To evaluate any additional benefits of the reversal of pharmacologically-induced mydriasis

Condition or disease Intervention/treatment Phase
Mydriasis Dilation Drug: Phentolamine Ophthalmic Solution 0.75% Other: Phentolamine Ophthalmic Solution Vehicle (Placebo) Phase 3

Detailed Description:

A randomized, parallel arm, double-masked, placebo-controlled Phase 3 study in at least 168 randomized subjects (160 completed), evaluating the safety and efficacy of Nyxol in subjects with pharmacologically-induced mydriasis.

Following the successful completion of screening, each subject will be stratified by eye color and then simultaneously be randomized to mydriatic agent (unmasked) and treatment (masked).

Treatment randomization will be 1:1, Nyxol or placebo (vehicle).

Stratification by iris color will be 1:1, light or dark irides.

The mydriatic agent randomization will be 3:1:1 (2.5% phenylephrine, 1% tropicamide, and Paremyd). That is, approximately 60% of the randomized subjects will receive one drop of 2.5% phenylephrine 1 hour before treatment (96 completed subjects), approximately 20% will receive one drop of 1% tropicamide 1 hour before treatment (32 completed subjects), and approximately 20% will receive Paremyd 1 hour before treatment (32 completed subjects).

At the treatment visit, subjects who have been randomized and stratified by iris color (1:1 [light/dark]) will receive one of three approved mydriatic agents approximately 1 hour prior to receiving study treatment. Measurements will be measured before (-1 hour /baseline) and 60 minutes after (maximum/0 minutes) the mydriatic agent instillation in each eye (i.e. right before the study treatment is administered), and at 30 minutes, 60 minutes, 90 minutes, 2 hours, 3 hours, 4 hours, and 6 hours after treatment dosing. Measurements will include pupil diameter (PD), distance and near visual acuity (VA), accommodation, and redness in each eye.

At the Follow-Up Visit, which is 1 day after Visit 1, measurements will again be recorded 24 hours after treatment dosing.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Parallel Arm, Double-Masked, Placebo-Controlled Study of the Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis in Healthy Subjects
Estimated Study Start Date : November 18, 2020
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Phentolamine Ophthalmic Solution 0.75%
2 drops in study eye and 1 drop in non-study eye, 1 hour post pharmacologically-induced mydriasis
Drug: Phentolamine Ophthalmic Solution 0.75%
0.75% phentolamine ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist
Other Names:
  • Nyxol
  • Nyxol®

Placebo Comparator: Phentolamine Ophthalmic Solution Vehicle
2 drops in study eye and 1 drop in non-study eye, 1 hour post pharmacologically-induced mydriasis
Other: Phentolamine Ophthalmic Solution Vehicle (Placebo)
Topical sterile ophthalmic solution




Primary Outcome Measures :
  1. Percent of Subjects' Study Eyes with Pupil Diameter Returning to Baseline [ Time Frame: 90 minutes ]
    Percentage of subjects' study eyes returning to less than or equal to 0.2 mm from baseline pupil diameter


Secondary Outcome Measures :
  1. Percent of Subjects with Pupil Diameter Returning to Baseline [ Time Frame: up to 24 hours ]
    Percentage of subjects returning to less than or equal to 0.2 mm from baseline pupil diameter

  2. Pupil Diameter (Change from Max) [ Time Frame: up to 24 hours ]
    Change (mm) from maximum pharmacologically-induced mydriatic pupil diameter (0 minutes)

  3. Percent of Subjects with Unchanged Accommodation from Baseline [ Time Frame: up to 6 hours ]
    Percentage of subjects with unchanged accommodation from baseline (-1 hour)



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Males or females ≥ 12 years of age
  2. Otherwise healthy and well controlled subjects

Exclusion Criteria:

Ophthalmic (in either eye):

  1. Clinically significant ocular disease as deemed by the Investigator that might interfere with the study
  2. Unwilling or unable to discontinue use of contact lenses at screening until study completion
  3. Unwilling or unable to suspend use of topical medication at screening until study completion
  4. Ocular trauma, ocular surgery or non-refractive laser treatment within the 6 months prior to screening
  5. Use of any topical prescription or over-the-counter (OTC) ophthalmic medications of any kind within 7 days of screening
  6. Recent or current evidence of ocular infection or inflammation in either eye
  7. History of diabetic retinopathy or diabetic macular edema
  8. Closed or very narrow angles that in the Investigator's opinion are potentially occludable if the subject's pupil is dilated
  9. History of any traumatic (surgical or nonsurgical) or non-traumatic condition affecting the pupil or iris
  10. Known allergy or contraindication to any component of the mydriatic agents or the vehicle formulation
  11. History of cauterization of the punctum or punctal plug (silicone or collagen) insertion or removal

Systemic:

  1. Known hypersensitivity or contraindication to α- and/or β adrenoceptor antagonists.
  2. Clinically significant systemic disease that might interfere with the study
  3. Initiation of treatment with or any changes to the current dosage, drug or regimen of any systemic adrenergic or cholinergic drugs within 7 days prior to screening, or during the study
  4. Participation in any investigational study within 30 days prior to screening
  5. Females of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control
  6. Resting HR outside the normal range (50-110 beats per minute)
  7. Hypertension with resting diastolic BP > 105 mmHg or systolic BP > 160 mmHg

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): NCT04620213


Contacts
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Contact: Roselyn Judd, BS 586-212-0237 roselyn.judd@oculoscr.com
Contact: Charles B Slonim, MD 813-690-0255 chuck.slonim@oculosCR.com

Locations
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United States, California
Clinical Site 11 Recruiting
Newport Beach, California, United States, 92663
Clinical Site 10 Recruiting
San Diego, California, United States, 92123
United States, Florida
Clinical Site 9 Recruiting
Longwood, Florida, United States, 32779
Clinical Site 6 Recruiting
Orlando, Florida, United States, 32751
United States, Georgia
Clinical Site 2 Recruiting
Roswell, Georgia, United States, 30075
United States, Kansas
Clinical Site 7 Recruiting
Pittsburg, Kansas, United States, 66762
Clinical Site 3 Recruiting
Shawnee Mission, Kansas, United States, 66203
United States, Ohio
Clinical Site 5 Recruiting
Athens, Ohio, United States, 45701
Clinical Site 12 Recruiting
Cincinnati, Ohio, United States, 45242
Clinical Site 1 Recruiting
Cleveland, Ohio, United States, 44195
United States, Rhode Island
Clinical Site 8 Recruiting
Warwick, Rhode Island, United States, 02888
United States, Tennessee
Clinical Site 4 Recruiting
Memphis, Tennessee, United States, 38119
Sponsors and Collaborators
Ocuphire Pharma, Inc.
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Responsible Party: Ocuphire Pharma, Inc.
ClinicalTrials.gov Identifier: NCT04620213    
Other Study ID Numbers: OPI-NYXRM-301 (MIRA-2)
First Posted: November 6, 2020    Key Record Dates
Last Update Posted: November 18, 2020
Last Verified: November 2020
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
Pharmaceutical Solutions
Ophthalmic Solutions
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antihypertensive Agents