PresbyopiaPhase 3VEGA-2NCT05646719
Safety and Efficacy of Nyxol Eye Drops as a Single Agent and With Adjunctive Low-Dose Pilocarpine Eye Drops in Subjects With Presbyopia
A Phase 3 study testing Phentolamine Opthalmic Solution 0.75% and Low dose pilocarpine in people with Presbyopia, run by Opus Genetics, Inc at 26 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 64 years
- Conditions the study is for
- Presbyopia
- What is being tested?
- Phentolamine Opthalmic Solution 0.75% and Low dose pilocarpine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 333 participants
- Where
- 26 sitesUnited States
- Study dates
- 22 Dec 2022to 11 Oct 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Males or females ≥ 40 and ≤ 64 years of age.
- BCDVA of 0.1 LogMAR (20/25 Snellen equivalent) or better in each eye in photopic conditions.
- 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.
- For subjects who depend on reading glasses or bifocals, binocular best-corrected near VA is 0.1 LogMAR (20/25 Snellen equivalent) or better.
- Photopic PD of ≥ 3 mm in either eye.
Who cannot join
- Ophthalmic (in either eye):
- 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.
- Use of any OTC artificial tears (preserved or unpreserved) during Visit days or 15 min before or after instillation of study medication.
- Current use of any topical ophthalmic therapy for dry eye.
- 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..
- Clinically significant ocular disease that might interfere with the study as deemed by the Investigator.
Show all 25Show fewer
- Recent or current evidence of ocular infection or inflammation in either eye.
- Any history of herpes simplex or herpes zoster keratitis.
- Known allergy, hypersensitivity, or contraindication to any component of the phentolamine, pilocarpine, or vehicle formulations.
- Prior participation in a study involving the use of Nyxol for the treatment of presbyopia.
- History of cauterization of the punctum or punctal plug (silicone or collagen) insertion or removal.
- Ocular trauma within 6 months prior to Screening.
- Ocular surgery or any ocular laser treatment within 6 months prior to Screening.
- Subjects with surgical monovision, multifocal or extended depth of focus intraocular lenses (IOLs) are excluded.
- History of any traumatic (surgical or nonsurgical) or nontraumatic condition affecting the pupil or iris.
- 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:
- Known hypersensitivity or contraindication to alpha- and/or beta-adrenoceptor antagonists .
- Known hypersensitivity or contraindication to any systemic cholinergic parasympathomimetic agent.
- Clinically significant systemic disease that might interfere with the study as deemed by the judgment of the Investigator.
- 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.
- Participation in any investigational study within 30 days prior to Screening.
- Females of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control.
- Resting HR outside the range of 50 to 110 beats per min.
- Hypertension with resting diastolic BP > 105 mmHg or systolic BP > 160 mmHg.
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
United States26 sites
Athens, OH
Athens, Ohio, 45701
Austin, TX
Austin, Texas, 73301
Azusa, CA
Azusa, California, 91702
Bloomington, MN
Bloomington, Minnesota, 55420
Chesterfield, MO
Chesterfield, Missouri, 63017
Cranberry Township, PA
Cranberry Township, Pennsylvania, 16066
Delray Beach, FL
Delray Beach, Florida, 33484
Fargo, ND
Fargo, North Dakota, 58103
Garner, NC
Garner, North Carolina, 27529
Houston, TX
Houston, Texas, 77055
Kansas City, MO
Kansas City, Missouri, 64133
Lake Villa, IL
Lake Villa, Illinois, 60046
Longwood, FL
Longwood, Florida, 32779
Memphis, TN
Memphis, Tennessee, 38119
New Freedom, PA
New Freedom, Pennsylvania, 17349
Newport Beach, CA
Newport Beach, California, 92663
Northridge, CA
Northridge, California, 91325
Phoenix, AZ
Phoenix, Arizona, 85003
Pittsburg, KS
Pittsburg, Kansas, 66762
Rochester, NY
Rochester, New York, 14618
Roswell, GA
Roswell, Georgia, 30076
San Antonio, TX
San Antonio, Texas, 78229
Shawnee Mission, KS
Shawnee Mission, Kansas, 66204
Sioux Falls, SD
Sioux Falls, South Dakota, 57108
Smithtown, NY
Smithtown, New York, 11787
Saint Louis, MO
St Louis, Missouri, 63128
About this study
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
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.
Read the detailed description
This is a 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
- Conditions
- Presbyopia
- Being tested
- Phentolamine Opthalmic Solution 0.75%, Placebo, Low dose pilocarpine, Low dose pilocarpine vehicle
- Keywords
- Nyxol, Presbyopia, Pilocarpine
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phentolamine Opthalmic Solution 0.75%Drug
Also called Nyxol
phentolamine ophthalmic solution 0.75% (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist
PlaceboOther
Also called Phentolamine Ophthalmic Solution Vehicle
Vehicle for Phentolamine Ophthalmic Solution
Low dose pilocarpineDrug
Also called Pilocarpine, LDP
Pilocarpine hydrochloride ophthalmic solution 0.4%
Low dose pilocarpine vehicleOther
Vehicle for low dose pilocarpine
| Study group | Role | What they receive |
|---|---|---|
| Nyxol + low dose pilocarpine | Experimental | Nyxol (phentolamine ophthalmic solution) 0.75% Pilocarpine (0.4%) Receives: Drug: Phentolamine Opthalmic Solution 0.75%; Drug: Low dose pilocarpine |
| Nyxol + low dose pilocarpine vehicle | Experimental | Nyxol (phentolamine ophthalmic solution) 0.75% Pilocarpine vehicle Receives: Drug: Phentolamine Opthalmic Solution 0.75%; Other: Low dose pilocarpine vehicle |
| Placebo + low dose pilocarpine | Experimental | Placebo Pilocarpine (0.4%) Receives: Other: Placebo; Drug: Low dose pilocarpine |
| Placebo + low dose pilocarpine vehicle | Experimental | Placebo Pilocarpine vehicle Receives: Other: Placebo; Other: Low dose pilocarpine vehicle |
| Nyxol | Experimental | Nyxol (phentolamine ophthalmic solution) 0.75% Receives: Drug: Phentolamine Opthalmic Solution 0.75% |
| Nyxol placebo | Experimental | Nyxol placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
The primary efficacy endpoint is the percent of subjects with ≥ 15 letters of improvement in photopic binocular DCNVA and with < 5 letters of loss in photopic binocular BCDVA from 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).
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start22 Dec 2022
- Primary completion11 Oct 2023
- Study completion11 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PresbyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 333 participants (actual)
Sponsor and investigators
- Lead sponsor
- Opus Genetics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05646719
- Sponsor's protocol ID
- OPI-NYXP-301 (VEGA-2)
- Acronym
- VEGA-2
- Status last verified
- Jun 2026
- First submitted
- 2 Dec 2022
- Last updated
- 30 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05646719
- Acronym / sponsor ID
- VEGA-2 / OPI-NYXP-301 (VEGA-2)
- Conditions
- Presbyopia
- Keywords
- Nyxol, Presbyopia, Pilocarpine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 333 participants (actual)
- Lead sponsor
- Opus Genetics, IncIndustry (pharma, biotech, devices)
- Study start
- 22 Dec 2022 (actual)
- Primary completion
- 11 Oct 2023 (actual)
- Study completion
- 11 Oct 2023 (actual)
- First posted
- 12 Dec 2022 (actual)
- Results
- Posted 3 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Nyxol + low dose pilocarpine | Experimental | Drug: Phentolamine Opthalmic Solution 0.75%, Drug: Low dose pilocarpineNyxol (phentolamine ophthalmic solution) 0.75% Pilocarpine (0.4%) |
| Nyxol + low dose pilocarpine vehicle | Experimental | Drug: Phentolamine Opthalmic Solution 0.75%, Other: Low dose pilocarpine vehicleNyxol (phentolamine ophthalmic solution) 0.75% Pilocarpine vehicle |
| Placebo + low dose pilocarpine | Experimental | Other: Placebo, Drug: Low dose pilocarpinePlacebo Pilocarpine (0.4%) |
| Placebo + low dose pilocarpine vehicle | Experimental | Other: Placebo, Other: Low dose pilocarpine vehiclePlacebo Pilocarpine vehicle |
| Nyxol | Experimental | Drug: Phentolamine Opthalmic Solution 0.75%Nyxol (phentolamine ophthalmic solution) 0.75% |
| Nyxol placebo | Experimental | Other: PlaceboNyxol placebo |
Who may qualify
- Ages
- 40 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Males or females ≥ 40 and ≤ 64 years of age.
- BCDVA of 0.1 LogMAR (20/25 Snellen equivalent) or better in each eye in photopic conditions.
- 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.
- For subjects who depend on reading glasses or bifocals, binocular best-corrected near VA is 0.1 LogMAR (20/25 Snellen equivalent) or better.
- Photopic PD of ≥ 3 mm in either eye.
Key exclusion criteria (25 listed)
- 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.
- Use of any OTC artificial tears (preserved or unpreserved) during Visit days or 15 min before or after instillation of study medication.
- Current use of any topical ophthalmic therapy for dry eye.
- 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..
- Clinically significant ocular disease that might interfere with the study as deemed by the Investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phentolamine Opthalmic Solution 0.75%Also: Nyxolphentolamine ophthalmic solution 0.75% (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist | Drug | Nyxol, Nyxol + low dose pilocarpine, Nyxol + low dose pilocarpine vehicle |
| PlaceboAlso: Phentolamine Ophthalmic Solution VehicleVehicle for Phentolamine Ophthalmic Solution | Other | Nyxol placebo, Placebo + low dose pilocarpine, Placebo + low dose pilocarpine vehicle |
| Low dose pilocarpineAlso: Pilocarpine, LDPPilocarpine hydrochloride ophthalmic solution 0.4% | Drug | Nyxol + low dose pilocarpine, Placebo + low dose pilocarpine |
| Low dose pilocarpine vehicleVehicle for low dose pilocarpine | Other | Nyxol + low dose pilocarpine vehicle, Placebo + low dose pilocarpine vehicle |
Primary outcome
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
Time frame: 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)
The primary efficacy endpoint is the percent of subjects with ≥ 15 letters of improvement in photopic binocular DCNVA and with < 5 letters of loss in photopic binocular BCDVA from 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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Phentolamine Opthalmic Solution 0.75% and Low dose pilocarpine in people with Presbyopia, run by Opus Genetics, Inc at 26 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.