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

Presbyopia Clinical Trial

Official title:

Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) With Pilocarpine Eye Drops in Subjects With Presbyopia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04675151
• Other study ID #: OPI-NYXP-201 (VEGA-1)
• Status: Completed
• Phase: Phase 2
• Start date: February 15, 2021
• Est. completion date: June 30, 2021

Study information

• Verified date: June 2023
• Source: Ocuphire Pharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objectives of this study are:

To evaluate the efficacy of Nyxol + Pilocarpine to improve DCNVA in subjects with presbyopia

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: June 30, 2021
• Est. primary completion date: May 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Presbyopia

Intervention

Drug:
• Phentolamine Ophthalmic Solution 0.75%
0.75% phentolamine ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist
• Pilocarpine
Pilocarpine ophthalmic solution

Other:
• Placebo
Topical sterile ophthalmic solution

Locations

Country	Name	City	State
United States	Clinical Site 2	Athens	Ohio
United States	Clinical Site 9	Cincinnati	Ohio
United States	Clinical Site 7	Cleveland	Ohio
United States	Clinical Site 13	Crystal River	Florida
United States	Clinical Site 14	Fargo	North Dakota
United States	Clinical Site 12	Laguna Hills	California
United States	Clinical Site 5	Longwood	Florida
United States	Clinical Site 11	Maitland	Florida
United States	Clinical Site 1	Memphis	Tennessee
United States	Clinical Site 6	Newport Beach	California
United States	Clinical Site 3	Pittsburg	Kansas
United States	Clinical Site 16	Poughkeepsie	New York
United States	Clinical Site 15	Powell	Ohio
United States	Clinical Site 10	Roswell	Georgia
United States	Clinical Site 18	Saint Louis	Missouri
United States	Clinical Site 8	Sarasota	Florida
United States	Clinical Site 4	Warwick	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Ocuphire Pharma, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Visit 2 at 1 hour
Secondary	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	Visit 2 at 0.5 hours, at 2 hours, at 3 hours, at 4 hours, and at 6 hours
Secondary	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	Visit 2 at 1 hour
Secondary	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	Visit 2 at 1 hour, at 3 hours, and at 6 hours