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

Primary Purpose

Mydriasis, Dilation

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Phentolamine Ophthalmic Solution 0.75%
Phentolamine Ophthalmic Solution Vehicle
Sponsored by
Ocuphire Pharma, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mydriasis focused on measuring Nyxol, Pharmacologically Induced Mydriasis, Dilation

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Clinical Site 10
  • Clinical Site 12
  • Clinical Site 9
  • Clinical Site 8
  • Clinical Site 6
  • Clinical Site 1
  • Clinical Site 13
  • Clinical Site 5
  • Clinical Site 2
  • Clinical Site 15
  • Clinical Site 4
  • Clinical Site 14
  • Clinical Site 7
  • Clinical Site 11
  • Clinical Site 3

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Phentolamine Ophthalmic Solution 0.75%

Phentolamine Ophthalmic Solution Vehicle

Arm Description

2 drops in study eye and 1 drop in non-study eye, 1 hour post pharmacologically-induced mydriasis

2 drops in study eye and 1 drop in non-study eye, 1 hour post pharmacologically-induced mydriasis

Outcomes

Primary Outcome Measures

Percent of Subjects' Study Eyes With Pupil Diameter Returning to Baseline
Percentage of subjects' study eyes returning to less than or equal to 0.2 mm from baseline pupil diameter

Secondary Outcome Measures

Percent of Subjects' Study Eyes With Pupil Diameter Returning to Baseline
Percentage of subjects' study eyes returning to less than or equal to 0.2 mm from baseline pupil diameter
Pupil Diameter (Change From Max)
Change (mm) from maximum pharmacologically-induced mydriatic pupil diameter (0 minutes)
Percent of Subjects With Unchanged Accommodation From Baseline
Percentage of subjects with unchanged accommodation from baseline (-1 hour)
Change From Baseline in Best-Corrected Distance Visual Acuity (BCDVA) Under Normal Photopic Lighting Without Glare Conditions
Change from Baseline in best-corrected distance visual acuity (BCDVA) under normal photopic lighting without glare conditions

Full Information

First Posted
November 16, 2021
Last Updated
August 7, 2023
Sponsor
Ocuphire Pharma, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05134974
Brief Title
Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis (MIRA-3)
Acronym
MIRA-3
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
November 18, 2021 (Actual)
Primary Completion Date
March 18, 2022 (Actual)
Study Completion Date
March 29, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ocuphire Pharma, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mydriasis, Dilation
Keywords
Nyxol, Pharmacologically Induced Mydriasis, Dilation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
368 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phentolamine Ophthalmic Solution 0.75%
Arm Type
Active Comparator
Arm Description
2 drops in study eye and 1 drop in non-study eye, 1 hour post pharmacologically-induced mydriasis
Arm Title
Phentolamine Ophthalmic Solution Vehicle
Arm Type
Placebo Comparator
Arm Description
2 drops in study eye and 1 drop in non-study eye, 1 hour post pharmacologically-induced mydriasis
Intervention Type
Drug
Intervention Name(s)
Phentolamine Ophthalmic Solution 0.75%
Other Intervention Name(s)
Nyxol®, Nyxol
Intervention Description
0.75% phentolamine ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist
Intervention Type
Drug
Intervention Name(s)
Phentolamine Ophthalmic Solution Vehicle
Intervention Description
Phentolamine Ophthalmic Solution Vehicle
Primary Outcome Measure Information:
Title
Percent of Subjects' Study Eyes With Pupil Diameter Returning to Baseline
Description
Percentage of subjects' study eyes returning to less than or equal to 0.2 mm from baseline pupil diameter
Time Frame
90 minutes
Secondary Outcome Measure Information:
Title
Percent of Subjects' Study Eyes With Pupil Diameter Returning to Baseline
Description
Percentage of subjects' study eyes returning to less than or equal to 0.2 mm from baseline pupil diameter
Time Frame
30 minutes to 24 hours
Title
Pupil Diameter (Change From Max)
Description
Change (mm) from maximum pharmacologically-induced mydriatic pupil diameter (0 minutes)
Time Frame
30 minutes to 24 hours
Title
Percent of Subjects With Unchanged Accommodation From Baseline
Description
Percentage of subjects with unchanged accommodation from baseline (-1 hour)
Time Frame
90 minutes to 6 Hours
Title
Change From Baseline in Best-Corrected Distance Visual Acuity (BCDVA) Under Normal Photopic Lighting Without Glare Conditions
Description
Change from Baseline in best-corrected distance visual acuity (BCDVA) under normal photopic lighting without glare conditions
Time Frame
6 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Males or females ≥ 12 years of age Ability to comply with all protocol-mandated procedures independently and to attend all scheduled office visits Exclusion Criteria: Clinically significant ocular disease as deemed by the Investigator (eg, glaucoma, corneal edema, uveitis, severe keratoconjunctivitis sicca) that might interfere with the study Unwilling or unable to discontinue use of contact lenses at screening until study completion Unwilling or unable to suspend use of topical medication at screening until study completion Ocular trauma, ocular surgery, or non-refractive laser treatment within the 6 months prior to screening 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.) 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 Closed or very narrow-angle that in the Investigator's opinion is potentially occludable if the subject's pupil is dilated Prior participation in a study involving the use of Nyxol for the reversal of mydriasis Known hypersensitivity or contraindication to α- and/or β-adrenoceptor antagonists Clinically significant systemic disease (eg, uncontrolled diabetes, myasthenia gravis, cancer, hepatic, renal, endocrine, or cardiovascular disorders) that might interfere with the study Participation in any investigational study within 30 days prior to screening Resting heart rate (HR) outside the normal range (50-110 beats per minute) at the Screening Visit. Hypertension with resting diastolic blood pressure (BP)>105 mmHg or systolic BP > 160 mmHg at the Screening Visit.
Facility Information:
Facility Name
Clinical Site 10
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Clinical Site 12
City
Westminster
State/Province
California
ZIP/Postal Code
92655
Country
United States
Facility Name
Clinical Site 9
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33484
Country
United States
Facility Name
Clinical Site 8
City
Longwood
State/Province
Florida
ZIP/Postal Code
32779
Country
United States
Facility Name
Clinical Site 6
City
Morrow
State/Province
Georgia
ZIP/Postal Code
30260
Country
United States
Facility Name
Clinical Site 1
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30009
Country
United States
Facility Name
Clinical Site 13
City
Lake Villa
State/Province
Illinois
ZIP/Postal Code
60046
Country
United States
Facility Name
Clinical Site 5
City
Pittsburg
State/Province
Kansas
ZIP/Postal Code
66762
Country
United States
Facility Name
Clinical Site 2
City
Bloomington
State/Province
Minnesota
ZIP/Postal Code
55420
Country
United States
Facility Name
Clinical Site 15
City
Garner
State/Province
North Carolina
ZIP/Postal Code
27529
Country
United States
Facility Name
Clinical Site 4
City
Athens
State/Province
Ohio
ZIP/Postal Code
45701
Country
United States
Facility Name
Clinical Site 14
City
Shrewsbury
State/Province
Pennsylvania
ZIP/Postal Code
17349
Country
United States
Facility Name
Clinical Site 7
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02888
Country
United States
Facility Name
Clinical Site 11
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57101
Country
United States
Facility Name
Clinical Site 3
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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