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

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 (Placebo)
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. 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

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 Pupil Diameter Returning to Baseline
Percentage of subjects' study eyesreturning 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)

Full Information

First Posted
November 2, 2020
Last Updated
August 15, 2023
Sponsor
Ocuphire Pharma, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04620213
Brief Title
Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis
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, 2020 (Actual)
Primary Completion Date
December 23, 2020 (Actual)
Study Completion Date
March 15, 2021 (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
Yes

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
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.

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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
185 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phentolamine Ophthalmic Solution 0.75%
Arm Type
Experimental
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
Other
Intervention Name(s)
Phentolamine Ophthalmic Solution Vehicle (Placebo)
Intervention Description
Topical sterile ophthalmic solution
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 Pupil Diameter Returning to Baseline
Description
Percentage of subjects' study eyesreturning to less than or equal to 0.2 mm from baseline pupil diameter
Time Frame
up to 24 hours
Title
Pupil Diameter (Change From Max)
Description
Change (mm) from maximum pharmacologically-induced mydriatic pupil diameter (0 minutes)
Time Frame
up 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
up to 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 Otherwise healthy and well controlled subjects Exclusion Criteria: Ophthalmic (in either eye): Clinically significant ocular disease as deemed by the Investigator 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 Recent or current evidence of ocular infection or inflammation in either eye History of diabetic retinopathy or diabetic macular edema Closed or very narrow angles that in the Investigator's opinion are potentially occludable if the subject's pupil is dilated History of any traumatic (surgical or nonsurgical) or non-traumatic condition affecting the pupil or iris Known allergy or contraindication to any component of the mydriatic agents or the vehicle formulation History of cauterization of the punctum or punctal plug (silicone or collagen) insertion or removal Systemic: Known hypersensitivity or contraindication to α- and/or β adrenoceptor antagonists. Clinically significant systemic disease that might interfere with the study 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 Participation in any investigational study within 30 days prior to screening Females of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control Resting HR outside the normal range (50-110 beats per minute) Hypertension with resting diastolic BP > 105 mmHg or systolic BP > 160 mmHg
Facility Information:
Facility Name
Clinical Site 11
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Clinical Site 10
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Clinical Site 9
City
Longwood
State/Province
Florida
ZIP/Postal Code
32779
Country
United States
Facility Name
Clinical Site 6
City
Orlando
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Clinical Site 2
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30075
Country
United States
Facility Name
Clinical Site 7
City
Pittsburg
State/Province
Kansas
ZIP/Postal Code
66762
Country
United States
Facility Name
Clinical Site 3
City
Shawnee Mission
State/Province
Kansas
ZIP/Postal Code
66203
Country
United States
Facility Name
Clinical Site 5
City
Athens
State/Province
Ohio
ZIP/Postal Code
45701
Country
United States
Facility Name
Clinical Site 12
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Clinical Site 1
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Clinical Site 8
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02888
Country
United States
Facility Name
Clinical Site 4
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

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