Safety and Efficacy of Nyxol Eye Drops as a Single Agent and With Adjunctive Low-Dose Pilocarpine Eye Drops in Subjects With Presbyopia
Public ClinicalTrials.gov record NCT05646719. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05646719
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 333 participants
Conditions and interventions
Conditions
Interventions
- Phentolamine Opthalmic Solution 0.75% Drug
- Placebo Other
- Low dose pilocarpine Drug
- Low dose pilocarpine vehicle Other
Drug · Other
Eligibility (public fields only)
- Age range
- 40 Years to 64 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 22, 2022 (Actual)
- Primary completion
- Oct 11, 2023 (Actual)
- Completion
- Oct 11, 2023 (Actual)
- Last update posted
- Jul 13, 2026
2022 – 2023
United States locations
- U.S. sites
- 26
- U.S. states
- 16
- U.S. cities
- 26
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Phoenix, AZ | Phoenix | Arizona | 85003 | — |
| Azusa, CA | Azusa | California | 91702 | — |
| Newport Beach, CA | Newport Beach | California | 92663 | — |
| Northridge, CA | Northridge | California | 91325 | — |
| Delray Beach, FL | Delray Beach | Florida | 33484 | — |
| Longwood, FL | Longwood | Florida | 32779 | — |
| Roswell, GA | Roswell | Georgia | 30076 | — |
| Lake Villa, IL | Lake Villa | Illinois | 60046 | — |
| Pittsburg, KS | Pittsburg | Kansas | 66762 | — |
| Shawnee Mission, KS | Shawnee Mission | Kansas | 66204 | — |
| Bloomington, MN | Bloomington | Minnesota | 55420 | — |
| Chesterfield, MO | Chesterfield | Missouri | 63017 | — |
| Kansas City, MO | Kansas City | Missouri | 64133 | — |
| Saint Louis, MO | St Louis | Missouri | 63128 | — |
| Rochester, NY | Rochester | New York | 14618 | — |
| Smithtown, NY | Smithtown | New York | 11787 | — |
| Garner, NC | Garner | North Carolina | 27529 | — |
| Fargo, ND | Fargo | North Dakota | 58103 | — |
| Athens, OH | Athens | Ohio | 45701 | — |
| Cranberry Township, PA | Cranberry Township | Pennsylvania | 16066 | — |
| New Freedom, PA | New Freedom | Pennsylvania | 17349 | — |
| Sioux Falls, SD | Sioux Falls | South Dakota | 57108 | — |
| Memphis, TN | Memphis | Tennessee | 38119 | — |
| Austin, TX | Austin | Texas | 73301 | — |
| Houston, TX | Houston | Texas | 77055 | — |
| San Antonio, TX | San Antonio | Texas | 78229 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05646719, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 13, 2026 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05646719 live on ClinicalTrials.gov.