Clinical trial NCT05646719: Safety and Efficacy of Nyxol Eye Drops as a Single Agent and With Adjunctive Low-Dose Pilocarpine Eye Drops in Subjects With Presbyopia
Official title: Randomized, Double-Masked, Placebo-Controlled, Multicenter, Phase 3 Study of the Safety and Efficacy of Nyxol (Phentolamine Ophthalmic Solution 0.75%) as a Single Agent and With Adjunctive Low-Dose Pilocarpine Hydrochloride Ophthalmic Solution 0.4% in Subjects With Presbyopia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Presbyopia
Keywords: Nyxol
Presbyopia
Pilocarpine
Lead sponsor: Ocuphire Pharma, Inc.
Sponsor class: INDUSTRY
First posted: 2022-12-12
Enrollment: 333
Sex: ALL
Minimum age (years): 40
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objectives of this study are:

To evaluate the safety and efficacy of Nyxol alone and with adjunctive low dose pilocarpine to improve distance-corrected near visual acuity (DCNVA) in subjects with presbyopia.


Eligibility criteria: Inclusion Criteria:

1. Males or females ≥ 40 and ≤ 64 years of age.
2. BCDVA of 0.1 LogMAR (20/25 Snellen equivalent) or better in each eye in photopic conditions.
3. DCNVA of 0.4 LogMAR (20/50 Snellen equivalent) or worse but not \> 0.7 LogMAR (20/100 Snellen equivalent) in photopic conditions in each eye and binocularly.
4. For subjects who depend on reading glasses or bifocals, binocular best-corrected near VA is 0.1 LogMAR (20/25 Snellen equivalent) or better.
5. Photopic PD of ≥ 3 mm in either eye.

Exclusion Criteria:

Ophthalmic (in either eye):

1. Use of any topical prescription or over-the-counter (OTC) ophthalmic medications of any kind within 7 days of Screening until study completion, with the exception of lid scrubs with OTC products and artificial tears as specified in Exclusion # 2 below.
2. Use of any OTC artificial tears (preserved or unpreserved) during Visit days or 15 min before or after instillation of study medication.
3. Current use of any topical ophthalmic therapy for dry eye.
4. Tear break-up time of \< 5 seconds or corneal fluorescein staining Grade ≥ 2 in the inferior zone or Grade ≥ 1 in the central zone using the National Eye Institute scale..
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. Known allergy, hypersensitivity, or contraindication to any component of the phentolamine, pilocarpine, or vehicle formulations.
9. Prior participation in a study involving the use of Nyxol for the treatment of presbyopia.
10. History of cauterization of the punctum or punctal plug (silicone or collagen) insertion or removal.
11. Ocular trauma within 6 months prior to Screening.
12. Ocular surgery or any ocular laser treatment within 6 months prior to Screening.
13. Subjects with surgical monovision, multifocal or extended depth of focus intraocular lenses (IOLs) are excluded.
14. History of any traumatic (surgical or nonsurgical) or nontraumatic condition affecting the pupil or iris.
15. Contact lens wear on the day of any study visit and contact lenses must be removed for home dosing and for at least 10 minutes following dosing.

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

Primary outcomes:
measure: Percent of Subjects With ≥ 15 Letters of Improvement in Photopic Binocular DCNVA and With < 5 Letters of Loss in Photopic Binocular BCDVA in Nyxol-treated Subjects
timeFrame: Baseline at 30 min post-LDP/vehicle comparing subjects treated with Nyxol + LDP to subjects treated with placebo + LDP vehicle at Visit 5 (Stage 2 Day 8)
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix, AZ
state: Arizona
city: Azusa
country: United States
facility: Azusa, CA
state: California
city: Newport Beach
country: United States
facility: Newport Beach, CA
state: California
city: Northridge
country: United States
facility: Northridge, CA
state: California
city: Delray Beach
country: United States
facility: Delray Beach, FL
state: Florida
city: Longwood
country: United States
facility: Longwood, FL
state: Florida
city: Roswell
country: United States
facility: Roswell, GA
state: Georgia
city: Lake Villa
country: United States
facility: Lake Villa, IL
state: Illinois
city: Pittsburg
country: United States
facility: Pittsburg, KS
state: Kansas
city: Shawnee Mission
country: United States
facility: Shawnee Mission, KS
state: Kansas
city: Bloomington
country: United States
facility: Bloomington, MN
state: Minnesota
city: Chesterfield
country: United States
facility: Chesterfield, MO
state: Missouri
city: Kansas City
country: United States
facility: Kansas City, MO
state: Missouri
city: Saint Louis
country: United States
facility: Saint Louis, MO
state: Missouri
city: Rochester
country: United States
facility: Rochester, NY
state: New York
city: Smithtown
country: United States
facility: Smithtown, NY
state: New York
city: Garner
country: United States
facility: Garner, NC
state: North Carolina
city: Fargo
country: United States
facility: Fargo, ND
state: North Dakota
city: Athens
country: United States
facility: Athens, OH
state: Ohio
city: Cranberry Township
country: United States
facility: Cranberry Township, PA
state: Pennsylvania
city: New Freedom
country: United States
facility: New Freedom, PA
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Sioux Falls, SD
state: South Dakota
city: Memphis
country: United States
facility: Memphis, TN
state: Tennessee
city: Austin
country: United States
facility: Austin, TX
state: Texas
city: Houston
country: United States
facility: Houston, TX
state: Texas
city: San Antonio
country: United States
facility: San Antonio, TX
state: Texas
Study officials:
References: