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

Ocuphire Pharma

Status and phase: Completed; Phase 2

Conditions: Presbyopia

Treatments: Drug: Phentolamine Ophthalmic Solution 0.75%; Other: Placebo; Drug: Pilocarpine

Study type: Interventional

Funder types: Industry

Identifiers

NCT04675151

OPI-NYXP-201 (VEGA-1)

Details and patient eligibility

About

The objectives of this study are:

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

Enrollment: 150 patients

Sex: All

Ages: 40 to 64 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 4 patient groups, including a placebo group

Nyxol + Pilocarpine

Experimental group

Description:

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

Treatment:

Drug: Pilocarpine

Drug: Phentolamine Ophthalmic Solution 0.75%

Nyxol

Active Comparator group

Description:

1 drop of Nyxol (Treatment 1)

Treatment:

Drug: Phentolamine Ophthalmic Solution 0.75%

Pilocarpine

Active Comparator group

Description:

1 drop of Pilocarpine (Treatment 2)

Treatment:

Drug: Pilocarpine

Other: Placebo

Placebo

Placebo Comparator group

Description:

1 drop of Placebo (Treatment 1)

Treatment:

Other: Placebo