Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis (MIRA-3)

Sponsor
Ocuphire Pharma, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT05134974
Collaborator
(none)
368
15
2
4.3
24.5
5.7

Study Details

Study Description

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
  • 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.

Study Design

Study Type:
Interventional
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 :
Nov 18, 2021
Actual Primary Completion Date :
Mar 18, 2022
Actual Study Completion Date :
Mar 29, 2022

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Percent of Subjects' Study Eyes with Pupil Diameter Returning to Baseline [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 [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) [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 [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 [6 hours]

      Change in best-corrected distance visual acuity (BCDVA) under normal photopic lighting versus glare

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clinical Site 10 Newport Beach California United States 92663
    2 Clinical Site 12 Westminster California United States 92655
    3 Clinical Site 9 Delray Beach Florida United States 33484
    4 Clinical Site 8 Longwood Florida United States 32779
    5 Clinical Site 6 Morrow Georgia United States 30260
    6 Clinical Site 1 Roswell Georgia United States 30009
    7 Clinical Site 13 Lake Villa Illinois United States 60046
    8 Clinical Site 5 Pittsburg Kansas United States 66762
    9 Clinical Site 2 Bloomington Minnesota United States 55420
    10 Clinical Site 15 Garner North Carolina United States 27529
    11 Clinical Site 4 Athens Ohio United States 45701
    12 Clinical Site 14 Shrewsbury Pennsylvania United States 17349
    13 Clinical Site 7 Warwick Rhode Island United States 02888
    14 Clinical Site 11 Sioux Falls South Dakota United States 57101
    15 Clinical Site 3 Memphis Tennessee United States 38119

    Sponsors and Collaborators

    • Ocuphire Pharma, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ocuphire Pharma, Inc.
    ClinicalTrials.gov Identifier:
    NCT05134974
    Other Study ID Numbers:
    • OPI-NYXRM-302 (MIRA-3)
    First Posted:
    Nov 26, 2021
    Last Update Posted:
    Jun 22, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ocuphire Pharma, Inc.
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 22, 2022