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Safety and Efficacy of Nyxol With Pilocarpine Eye Drops in Subjects With Presbyopia

Primary Purpose

Presbyopia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Phentolamine Ophthalmic Solution 0.75%
Pilocarpine
Placebo
Sponsored by
Ocuphire Pharma, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Presbyopia focused on measuring Nyxol, Presbyopia, Pilocarpine

Eligibility Criteria

40 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Males or females ≥ 40 and ≤ 64years of age.
  2. BCDVA of 0.0 LogMAR(20/20 Snellen equivalent) or better in each eye under photopic conditions.
  3. DCNVA of 0.4 LogMAR (20/50 Snellen equivalent) or worse under photopic conditions in each eye and binocularly.
  4. Subjects who depend on reading glasses or bifocals in which their binocular best-corrected near VA is 0.1 LogMAR (20/25 Snellen equivalent) or better.

Exclusion Criteria:

Ophthalmic (in either eye):

  1. Use of any topical prescription or OTC ophthalmic medications of any kind within 7 days of Screening until study completion.
  2. Use of any over-the-counter (OTC) artificial tears (preserved or unpreserved) at least once per day within 7 days of Screening until study completion.
  3. Current use of any topical ophthalmic therapy for dry eye.
  4. Tear break-up time of < 5 seconds or corneal fluorescein staining.
  5. Clinically significant ocular disease that might interfere with the study as deemed by the Investigator.
  6. Recent or current evidence of ocular infection or inflammation in either eye.
  7. Any history of herpes simplex or herpes zoster keratitis.
  8. History of diabetic retinopathy or diabetic macular edema.
  9. Known allergy, hypersensitivity, or contraindication to any component of the phentolamine, pilocarpine, or vehicle formulations.
  10. History of cauterization of the punctum or punctal plug (silicone or collagen) insertion or removal.
  11. Ocular trauma, ocular surgery, ocular laser treatment within the 6 months prior to Screening. Any subject with multifocal intraocular lenses are excluded.
  12. History of any traumatic (surgical or nonsurgical) or non traumatic condition affecting the pupil or iris.
  13. Unwilling or unable to discontinue use of contact lenses.

  14. Conjunctival hyperemia ≥ grade 2 on the CCLRU 4-point scale.

    Systemic:

  15. Known hypersensitivity or contraindication to alpha- and/or beta adrenoceptor antagonists.
  16. Known hypersensitivity or contraindication to any systemic cholinergic parasympathomimetic agents.
  17. Clinically significant systemic disease that might interfere with the study as deemed by the Investigator.
  18. Participation in any investigational study within 30 days prior to Screening.
  19. Females of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control.
  20. Resting HR outside the specified range of 50 to 110 beats per minute.
  21. Hypertension with resting diastolic BP > 105 mmHg or systolic BP > 160 mmHg.

Sites / Locations

  • Clinical Site 12
  • Clinical Site 6
  • Clinical Site 13
  • Clinical Site 5
  • Clinical Site 11
  • Clinical Site 8
  • Clinical Site 10
  • Clinical Site 3
  • Clinical Site 18
  • Clinical Site 16
  • Clinical Site 14
  • Clinical Site 2
  • Clinical Site 9
  • Clinical Site 7
  • Clinical Site 15
  • Clinical Site 4
  • Clinical Site 1

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Nyxol + Pilocarpine

Nyxol

Pilocarpine

Placebo

Arm Description

1 drop of Nyxol (Treatment 1) and 1 drop of Pilocarpine (Treatment 2)

1 drop of Nyxol (Treatment 1)

1 drop of Pilocarpine (Treatment 2)

1 drop of Placebo (Treatment 1)

Outcomes

Primary Outcome Measures

Percent of Subjects With ≥ 15 Letters of Improvement in Photopic Binocular DCNVA
The primary efficacy endpoint was the percent of subjects with ≥ 15 letters of improvement in photopic binocular DCNVA on Visit 2 at 1 hour with POS + LDP compared to placebo alone. The improvement in binocular DCNVA for each subject was relative to the subject's own baseline value (Visit 1).

Secondary Outcome Measures

Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline
The percentage of subjects with improvement of ≥ 5, ≥ 10, and ≥ 15 letters in DCNVA (photopic) from Baseline at 0.5 hours, at 2 hours, at 3 hours, at 4 hours, and at 6 hours
Percentage of Subjects With Improvement of ≥ 15 Letters in DCNVA (Photopic) at 1 Hour and With < 5 Letters of Loss in Photopic Binocular BCDVA From Baseline
The percentage of subjects with improvement of ≥ 15 letters in DCNVA (photopic) at 1 hour and with < 5 letters of loss in photopic binocular BCDVA from Baseline
Percentage of Subjects With Improvement in DCIVA (Photopic) From Baseline
The percentage of subjects with improvement in DCIVA (photopic) from Baseline of ≥ 5, ≥ 10, and ≥ 15 letters

Full Information

First Posted
December 15, 2020
Last Updated
August 11, 2023
Sponsor
Ocuphire Pharma, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04675151
Brief Title
Safety and Efficacy of Nyxol With Pilocarpine Eye Drops in Subjects With Presbyopia
Official Title
Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) With Pilocarpine Eye Drops in Subjects With Presbyopia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
February 15, 2021 (Actual)
Primary Completion Date
May 17, 2021 (Actual)
Study Completion Date
June 30, 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 + Pilocarpine to improve DCNVA in subjects with presbyopia

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presbyopia
Keywords
Nyxol, Presbyopia, Pilocarpine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nyxol + Pilocarpine
Arm Type
Experimental
Arm Description
1 drop of Nyxol (Treatment 1) and 1 drop of Pilocarpine (Treatment 2)
Arm Title
Nyxol
Arm Type
Active Comparator
Arm Description
1 drop of Nyxol (Treatment 1)
Arm Title
Pilocarpine
Arm Type
Active Comparator
Arm Description
1 drop of Pilocarpine (Treatment 2)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
1 drop of Placebo (Treatment 1)
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)
Pilocarpine
Intervention Description
Pilocarpine ophthalmic solution
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Phentolamine Ophthalmic Solution Vehicle
Intervention Description
Topical sterile ophthalmic solution
Primary Outcome Measure Information:
Title
Percent of Subjects With ≥ 15 Letters of Improvement in Photopic Binocular DCNVA
Description
The primary efficacy endpoint was the percent of subjects with ≥ 15 letters of improvement in photopic binocular DCNVA on Visit 2 at 1 hour with POS + LDP compared to placebo alone. The improvement in binocular DCNVA for each subject was relative to the subject's own baseline value (Visit 1).
Time Frame
Visit 2 at 1 hour
Secondary Outcome Measure Information:
Title
Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline
Description
The percentage of subjects with improvement of ≥ 5, ≥ 10, and ≥ 15 letters in DCNVA (photopic) from Baseline at 0.5 hours, at 2 hours, at 3 hours, at 4 hours, and at 6 hours
Time Frame
Visit 2 at 0.5 hours, at 2 hours, at 3 hours, at 4 hours, and at 6 hours
Title
Percentage of Subjects With Improvement of ≥ 15 Letters in DCNVA (Photopic) at 1 Hour and With < 5 Letters of Loss in Photopic Binocular BCDVA From Baseline
Description
The percentage of subjects with improvement of ≥ 15 letters in DCNVA (photopic) at 1 hour and with < 5 letters of loss in photopic binocular BCDVA from Baseline
Time Frame
Visit 2 at 1 hour
Title
Percentage of Subjects With Improvement in DCIVA (Photopic) From Baseline
Description
The percentage of subjects with improvement in DCIVA (photopic) from Baseline of ≥ 5, ≥ 10, and ≥ 15 letters
Time Frame
Visit 2 at 1 hour, at 3 hours, and at 6 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males or females ≥ 40 and ≤ 64years of age. BCDVA of 0.0 LogMAR(20/20 Snellen equivalent) or better in each eye under photopic conditions. DCNVA of 0.4 LogMAR (20/50 Snellen equivalent) or worse under photopic conditions in each eye and binocularly. Subjects who depend on reading glasses or bifocals in which their binocular best-corrected near VA is 0.1 LogMAR (20/25 Snellen equivalent) or better. Exclusion Criteria: Ophthalmic (in either eye): Use of any topical prescription or OTC ophthalmic medications of any kind within 7 days of Screening until study completion. Use of any over-the-counter (OTC) artificial tears (preserved or unpreserved) at least once per day within 7 days of Screening until study completion. Current use of any topical ophthalmic therapy for dry eye. Tear break-up time of < 5 seconds or corneal fluorescein staining. Clinically significant ocular disease that might interfere with the study as deemed by the Investigator. Recent or current evidence of ocular infection or inflammation in either eye. Any history of herpes simplex or herpes zoster keratitis. History of diabetic retinopathy or diabetic macular edema. Known allergy, hypersensitivity, or contraindication to any component of the phentolamine, pilocarpine, or vehicle formulations. History of cauterization of the punctum or punctal plug (silicone or collagen) insertion or removal. Ocular trauma, ocular surgery, ocular laser treatment within the 6 months prior to Screening. Any subject with multifocal intraocular lenses are excluded. History of any traumatic (surgical or nonsurgical) or non traumatic condition affecting the pupil or iris. Unwilling or unable to discontinue use of contact lenses. Conjunctival hyperemia ≥ grade 2 on the CCLRU 4-point scale. Systemic: Known hypersensitivity or contraindication to alpha- and/or beta adrenoceptor antagonists. Known hypersensitivity or contraindication to any systemic cholinergic parasympathomimetic agents. Clinically significant systemic disease that might interfere with the study as deemed by the Investigator. 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 specified range of 50 to 110 beats per minute. Hypertension with resting diastolic BP > 105 mmHg or systolic BP > 160 mmHg.
Facility Information:
Facility Name
Clinical Site 12
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
Clinical Site 6
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Clinical Site 13
City
Crystal River
State/Province
Florida
ZIP/Postal Code
34461
Country
United States
Facility Name
Clinical Site 5
City
Longwood
State/Province
Florida
ZIP/Postal Code
32779
Country
United States
Facility Name
Clinical Site 11
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Clinical Site 8
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Clinical Site 10
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30041
Country
United States
Facility Name
Clinical Site 3
City
Pittsburg
State/Province
Kansas
ZIP/Postal Code
66762
Country
United States
Facility Name
Clinical Site 18
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63101
Country
United States
Facility Name
Clinical Site 16
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12603
Country
United States
Facility Name
Clinical Site 14
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
Clinical Site 2
City
Athens
State/Province
Ohio
ZIP/Postal Code
45701
Country
United States
Facility Name
Clinical Site 9
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Clinical Site 7
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44115
Country
United States
Facility Name
Clinical Site 15
City
Powell
State/Province
Ohio
ZIP/Postal Code
43065
Country
United States
Facility Name
Clinical Site 4
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02888
Country
United States
Facility Name
Clinical Site 1
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Safety and Efficacy of Nyxol With Pilocarpine Eye Drops in Subjects With Presbyopia

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