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

Sponsor
Ocuphire Pharma, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04620213
Collaborator
(none)
185
12
2
3.8
15.4
4

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

Condition or Disease Intervention/Treatment Phase
  • 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
185 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
Actual Study Start Date :
Nov 18, 2020
Actual Primary Completion Date :
Dec 23, 2020
Actual Study Completion Date :
Mar 15, 2021

Arms and Interventions

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

    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 with Pupil Diameter Returning to Baseline [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) [up to 24 hours]

      Change (mm) from maximum pharmacologically-induced mydriatic pupil diameter (0 minutes)

    3. Percent of Subjects with Unchanged Accommodation from Baseline [up to 6 hours]

      Percentage of subjects with unchanged accommodation from baseline (-1 hour)

    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. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clinical Site 11 Newport Beach California United States 92663
    2 Clinical Site 10 San Diego California United States 92123
    3 Clinical Site 9 Longwood Florida United States 32779
    4 Clinical Site 6 Orlando Florida United States 32751
    5 Clinical Site 2 Roswell Georgia United States 30075
    6 Clinical Site 7 Pittsburg Kansas United States 66762
    7 Clinical Site 3 Shawnee Mission Kansas United States 66203
    8 Clinical Site 5 Athens Ohio United States 45701
    9 Clinical Site 12 Cincinnati Ohio United States 45242
    10 Clinical Site 1 Cleveland Ohio United States 44195
    11 Clinical Site 8 Warwick Rhode Island United States 02888
    12 Clinical Site 4 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:
    NCT04620213
    Other Study ID Numbers:
    • OPI-NYXRM-301 (MIRA-2)
    First Posted:
    Nov 6, 2020
    Last Update Posted:
    Mar 18, 2021
    Last Verified:
    Mar 1, 2021
    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 Mar 18, 2021