Clinical trial NCT04675151: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Presbyopia
Keywords: Nyxol
Presbyopia
Pilocarpine
Lead sponsor: Ocuphire Pharma, Inc.
Sponsor class: INDUSTRY
First posted: 2020-12-19
Enrollment: 150
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 efficacy of Nyxol + Pilocarpine to improve DCNVA in subjects with presbyopia


Eligibility criteria: 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.

Primary outcomes:
measure: Percent of Subjects With ≥ 15 Letters of Improvement in Photopic Binocular DCNVA
timeFrame: Visit 2 at 1 hour
Secondary outcomes:
measure: Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline
timeFrame: Visit 2 at 0.5 hours, at 2 hours, at 3 hours, at 4 hours, and at 6 hours
measure: 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
timeFrame: Visit 2 at 1 hour
measure: Percentage of Subjects With Improvement in DCIVA (Photopic) From Baseline
timeFrame: Visit 2 at 1 hour, at 3 hours, and at 6 hours
Other outcomes:
Locations:
city: Laguna Hills
country: United States
facility: Clinical Site 12
state: California
city: Newport Beach
country: United States
facility: Clinical Site 6
state: California
city: Crystal River
country: United States
facility: Clinical Site 13
state: Florida
city: Longwood
country: United States
facility: Clinical Site 5
state: Florida
city: Maitland
country: United States
facility: Clinical Site 11
state: Florida
city: Sarasota
country: United States
facility: Clinical Site 8
state: Florida
city: Roswell
country: United States
facility: Clinical Site 10
state: Georgia
city: Pittsburg
country: United States
facility: Clinical Site 3
state: Kansas
city: Saint Louis
country: United States
facility: Clinical Site 18
state: Missouri
city: Poughkeepsie
country: United States
facility: Clinical Site 16
state: New York
city: Fargo
country: United States
facility: Clinical Site 14
state: North Dakota
city: Athens
country: United States
facility: Clinical Site 2
state: Ohio
city: Cincinnati
country: United States
facility: Clinical Site 9
state: Ohio
city: Cleveland
country: United States
facility: Clinical Site 7
state: Ohio
city: Powell
country: United States
facility: Clinical Site 15
state: Ohio
city: Warwick
country: United States
facility: Clinical Site 4
state: Rhode Island
city: Memphis
country: United States
facility: Clinical Site 1
state: Tennessee
Study officials:
References: