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Trial record 1 of 1 for:    Mira-3
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Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis (MIRA-3) (MIRA-3)

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: NCT05134974
Recruitment Status : Completed
First Posted : November 26, 2021
Last Update Posted : June 22, 2022
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
  • To evaluate the systemic exposure of Nyxol on pharmacokinetic (PK) sampling

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

Detailed Description:

A randomized, parallel arm, double-masked, placebo-controlled Phase 3 study in at least 330 randomized subjects, 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 2:1, Nyxol or placebo (vehicle). Stratification by iris color will be 1:1, light or dark rides. The mydriatic agent randomization will be 3:1:1 (2.5% phenylephrine, 1% tropicamide, and Paremyd).

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.

Blood sampling for Nyxol PK measurements will be conducted in a subset of approximately 30 adult subjects at approximately two select study sites.

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)
Actual Enrollment : 368 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Actual Study Start Date : November 18, 2021
Actual Primary Completion Date : March 18, 2022
Actual Study Completion Date : March 29, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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
Drug: Phentolamine Ophthalmic Solution Vehicle
Phentolamine Ophthalmic Solution Vehicle




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' Study Eyes with Pupil Diameter Returning to Baseline [ Time Frame: 30 minutes to 24 hours ]
    Percentage of subjects' study eyes returning to less than or equal to 0.2 mm from baseline pupil diameter

  2. Pupil Diameter (Change from Max) [ Time Frame: 30 minutes 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: 2 hours ]
    Percentage of subjects with unchanged accommodation from baseline (-1 hour)

  4. Change in Best-Corrected Distance Visual Acuity (BCDVA) Under Normal Photopic Lighting Versus Glare [ Time Frame: 6 hours ]
    Change in best-corrected distance visual acuity (BCDVA) under normal photopic lighting versus glare



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. Ability to comply with all protocol-mandated procedures independently and to attend all scheduled office visits

Exclusion Criteria:

  1. Clinically significant ocular disease as deemed by the Investigator (eg, glaucoma, corneal edema, uveitis, severe keratoconjunctivitis sicca) 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, with the exception of lid scrubs with OTC products (eg, OCuSOFT® lid scrub, SteriLid®, baby shampoo, etc.)
  6. Recent or current evidence of ocular infection or inflammation in either eye (such as current evidence of clinically significant blepharitis, conjunctivitis, or keratitis). Subjects must be symptom-free for at least 7 days prior to screening
  7. Closed or very narrow-angle that in the Investigator's opinion is potentially occludable if the subject's pupil is dilated
  8. Prior participation in a study involving the use of Nyxol for the reversal of mydriasis
  9. Known hypersensitivity or contraindication to α- and/or β-adrenoceptor antagonists
  10. Clinically significant systemic disease (eg, uncontrolled diabetes, myasthenia gravis, cancer, hepatic, renal, endocrine, or cardiovascular disorders) that might interfere with the study
  11. Participation in any investigational study within 30 days prior to screening
  12. Resting heart rate (HR) outside the normal range (50-110 beats per minute) at the Screening Visit.
  13. Hypertension with resting diastolic blood pressure (BP)>105 mmHg or systolic BP > 160 mmHg at the Screening Visit.

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): NCT05134974


Locations
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United States, California
Clinical Site 10
Newport Beach, California, United States, 92663
Clinical Site 12
Westminster, California, United States, 92655
United States, Florida
Clinical Site 9
Delray Beach, Florida, United States, 33484
Clinical Site 8
Longwood, Florida, United States, 32779
United States, Georgia
Clinical Site 6
Morrow, Georgia, United States, 30260
Clinical Site 1
Roswell, Georgia, United States, 30009
United States, Illinois
Clinical Site 13
Lake Villa, Illinois, United States, 60046
United States, Kansas
Clinical Site 5
Pittsburg, Kansas, United States, 66762
United States, Minnesota
Clinical Site 2
Bloomington, Minnesota, United States, 55420
United States, North Carolina
Clinical Site 15
Garner, North Carolina, United States, 27529
United States, Ohio
Clinical Site 4
Athens, Ohio, United States, 45701
United States, Pennsylvania
Clinical Site 14
Shrewsbury, Pennsylvania, United States, 17349
United States, Rhode Island
Clinical Site 7
Warwick, Rhode Island, United States, 02888
United States, South Dakota
Clinical Site 11
Sioux Falls, South Dakota, United States, 57101
United States, Tennessee
Clinical Site 3
Memphis, Tennessee, United States, 38119
Sponsors and Collaborators
Ocuphire Pharma, Inc.
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Responsible Party: Ocuphire Pharma, Inc.
ClinicalTrials.gov Identifier: NCT05134974    
Other Study ID Numbers: OPI-NYXRM-302 (MIRA-3)
First Posted: November 26, 2021    Key Record Dates
Last Update Posted: June 22, 2022
Last Verified: June 2022
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