PresbyopiaPhase 2NCT04675151

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

A Phase 2 study testing Phentolamine Ophthalmic Solution 0.75% and Pilocarpine in people with Presbyopia, run by Opus Genetics, Inc at 17 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The objectives of this study are: To evaluate the efficacy of Nyxol + Pilocarpine to improve 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 Ophthalmic Solution 0.75% and Pilocarpine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 150 participants
Where: 17 sitesUnited States
Study dates: 15 Feb 2021to 30 Jun 2021
Phase: Phase 2
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 ≤ 64years of age.
BCDVA of 0.0 LogMAR(20/20 Snellen equivalent) or better in each eye under photopic conditions.
DCNVA of 0.4 LogMAR (20/50 Snellen equivalent) or worse under photopic conditions in each eye and binocularly.
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.

Who cannot join

Ophthalmic (in either eye):
Use of any topical prescription or OTC ophthalmic medications of any kind within 7 days of Screening until study completion.
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.
Current use of any topical ophthalmic therapy for dry eye.
Tear break-up time of < 5 seconds or corneal fluorescein staining.
Clinically significant ocular disease that might interfere with the study as deemed by the Investigator.

Show all 23Show fewer

Recent or current evidence of ocular infection or inflammation in either eye.
Any history of herpes simplex or herpes zoster keratitis.
History of diabetic retinopathy or diabetic macular edema.
Known allergy, hypersensitivity, or contraindication to any component of the phentolamine, pilocarpine, or vehicle formulations.
History of cauterization of the punctum or punctal plug (silicone or collagen) insertion or removal.
Ocular trauma, ocular surgery, ocular laser treatment within the 6 months prior to Screening. Any subject with multifocal intraocular lenses are excluded.
History of any traumatic (surgical or nonsurgical) or non traumatic condition affecting the pupil or iris.
Unwilling or unable to discontinue use of contact lenses.
Conjunctival hyperemia ≥ grade 2 on the CCLRU 4-point scale.
Systemic:
Known hypersensitivity or contraindication to alpha- and/or beta adrenoceptor antagonists.
Known hypersensitivity or contraindication to any systemic cholinergic parasympathomimetic agents.
Clinically significant systemic disease that might interfere with the study as deemed by the Investigator.
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 specified range of 50 to 110 beats per minute.
Hypertension with resting diastolic BP > 105 mmHg or systolic BP > 160 mmHg.

Trial locations and contacts

17 sites in 1 country.

City, postcode or hospital

17 sites in 1 country

United States17 sites

Clinical Site 2
Athens, Ohio, 45701
Clinical Site 9
Cincinnati, Ohio, 45242
Clinical Site 7
Cleveland, Ohio, 44115
Clinical Site 13
Crystal River, Florida, 34461
Clinical Site 14
Fargo, North Dakota, 58103
Clinical Site 12
Laguna Hills, California, 92653
Clinical Site 5
Longwood, Florida, 32779
Clinical Site 11
Maitland, Florida, 32751
Clinical Site 1
Memphis, Tennessee, 38119
Clinical Site 6
Newport Beach, California, 92663
Clinical Site 3
Pittsburg, Kansas, 66762
Clinical Site 16
Poughkeepsie, New York, 12603
Clinical Site 15
Powell, Ohio, 43065
Clinical Site 10
Roswell, Georgia, 30041
Clinical Site 8
Sarasota, Florida, 34239
Clinical Site 18
St Louis, Missouri, 63101
Clinical Site 4
Warwick, Rhode Island, 02888

Other trials in United States

About this study

Official title: Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) With Pilocarpine Eye Drops in Subjects With Presbyopia

The objectives of this study are:

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

Conditions: Presbyopia
Being tested: Phentolamine Ophthalmic Solution 0.75%, Pilocarpine, Placebo
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 Ophthalmic Solution 0.75%Drug
Also called Nyxol, Nyxol®
0.75% phentolamine ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist
PilocarpineDrug
Pilocarpine ophthalmic solution
PlaceboOther
Also called Phentolamine Ophthalmic Solution Vehicle
Topical sterile ophthalmic solution

Study groups in NCT04675151
Study group	Role	What they receive
Nyxol + Pilocarpine	Experimental	1 drop of Nyxol (Treatment 1) and 1 drop of Pilocarpine (Treatment 2) Receives: Drug: Phentolamine Ophthalmic Solution 0.75%; Drug: Pilocarpine
Nyxol	Active comparator	1 drop of Nyxol (Treatment 1) Receives: Drug: Phentolamine Ophthalmic Solution 0.75%
Pilocarpine	Active comparator	1 drop of Pilocarpine (Treatment 2) Receives: Drug: Pilocarpine; Other: Placebo
Placebo	Placebo comparator	1 drop of Placebo (Treatment 1) 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
The primary efficacy endpoint was the percent of subjects with ≥ 15 letters of improvement in photopic binocular DCNVA on Visit 2 at 1 hour with POS + LDP compared to placebo alone. The improvement in binocular DCNVA for each subject was relative to the subject's own baseline value (Visit 1).
Measured: Visit 2 at 1 hour

Secondary outcomes (3)

Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline
The percentage of subjects with improvement of ≥ 5, ≥ 10, and ≥ 15 letters in DCNVA (photopic) from Baseline at 0.5 hours, at 2 hours, at 3 hours, at 4 hours, and at 6 hours
Measured: Visit 2 at 0.5 hours, at 2 hours, at 3 hours, at 4 hours, and at 6 hours
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
The 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
Measured: Visit 2 at 1 hour
Percentage of Subjects With Improvement in DCIVA (Photopic) From Baseline
The percentage of subjects with improvement in DCIVA (photopic) from Baseline of ≥ 5, ≥ 10, and ≥ 15 letters
Measured: Visit 2 at 1 hour, at 3 hours, and at 6 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Feb 202130 Jun 2021

First posted19 Dec 2020
Study start15 Feb 2021
Primary completion17 May 2021
Study completion30 Jun 2021

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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 150 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04675151
Sponsor's protocol ID: OPI-NYXP-201 (VEGA-1)
Status last verified: Jun 2023
First submitted: 15 Dec 2020
Last updated: 30 Oct 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Clinical Trial With Artiflex Presbyopic (Artiplus)
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VisDura VisAbility™ Micro Insert System Pre-market Clinical Trial
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Volumetric Visual Fields at Intermediate and Near Distances in Presbyopic Patients Using Occupational and General-Purpose Progressive Addition Lenses
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All Presbyopia trials

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: Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) With Pilocarpine Eye Drops in Subjects With Presbyopia
ClinicalTrials.gov ID: NCT04675151
Acronym / sponsor ID: OPI-NYXP-201 (VEGA-1)
Conditions: Presbyopia
Keywords: Nyxol, Presbyopia, Pilocarpine
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 150 participants (actual)
Lead sponsor: Opus Genetics, IncIndustry (pharma, biotech, devices)
Study start: 15 Feb 2021 (actual)
Primary completion: 17 May 2021 (actual)
Study completion: 30 Jun 2021 (actual)
First posted: 19 Dec 2020 (actual)
Results: Posted 2 Aug 2023

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 efficacy of Nyxol + Pilocarpine to improve DCNVA 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: 4

Arm	Type	Receives
Nyxol + Pilocarpine	Experimental	Drug: Phentolamine Ophthalmic Solution 0.75%, Drug: Pilocarpine1 drop of Nyxol (Treatment 1) and 1 drop of Pilocarpine (Treatment 2)
Nyxol	Active comparator	Drug: Phentolamine Ophthalmic Solution 0.75%1 drop of Nyxol (Treatment 1)
Pilocarpine	Active comparator	Drug: Pilocarpine, Other: Placebo1 drop of Pilocarpine (Treatment 2)
Placebo	Placebo comparator	Other: Placebo1 drop of Placebo (Treatment 1)

Who may qualify

Ages: 40 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Males or females ≥ 40 and ≤ 64years of age.
BCDVA of 0.0 LogMAR(20/20 Snellen equivalent) or better in each eye under photopic conditions.
DCNVA of 0.4 LogMAR (20/50 Snellen equivalent) or worse under photopic conditions in each eye and binocularly.
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.

Key exclusion criteria (23 listed)

Use of any topical prescription or OTC ophthalmic medications of any kind within 7 days of Screening until study completion.
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.
Current use of any topical ophthalmic therapy for dry eye.
Tear break-up time of < 5 seconds or corneal fluorescein staining.
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 Ophthalmic Solution 0.75%Also: Nyxol, Nyxol®0.75% phentolamine ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist	Drug	Nyxol, Nyxol + Pilocarpine
PilocarpinePilocarpine ophthalmic solution	Drug	Nyxol + Pilocarpine, Pilocarpine
PlaceboAlso: Phentolamine Ophthalmic Solution VehicleTopical sterile ophthalmic solution	Other	Pilocarpine, Placebo

Primary outcome

Percent of Subjects With ≥ 15 Letters of Improvement in Photopic Binocular DCNVA
Time frame: Visit 2 at 1 hour
The primary efficacy endpoint was the percent of subjects with ≥ 15 letters of improvement in photopic binocular DCNVA on Visit 2 at 1 hour with POS + LDP compared to placebo alone. The improvement in binocular DCNVA for each subject was relative to the subject's own baseline value (Visit 1).

3 secondary outcomes

Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline
Time frame: Visit 2 at 0.5 hours, at 2 hours, at 3 hours, at 4 hours, and at 6 hours
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
Time frame: Visit 2 at 1 hour
Percentage of Subjects With Improvement in DCIVA (Photopic) From Baseline
Time frame: Visit 2 at 1 hour, at 3 hours, and at 6 hours

Results and safety

Results posted to the registry on 2 Aug 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
POS 0.75% First, Then LDP 0.4%	44	43
POS 0.75% First, Then LDP Vehicle	30	30
POS Vehicle First, Then LDP 0.4%	31	31
POS Vehicle First, Then LDP Vehicle	45	44

Primary outcome: Percent of Subjects With ≥ 15 Letters of Improvement in Photopic Binocular DCNVA

Time frame: Visit 2 at 1 hour. Number. Unit: percentage of subjects with ≥ 15 letters

Measure	POS 0.75% First, Then LDP 0.4% n = 43	POS 0.75% First, Then LDP Vehicle n = 30	POS Vehicle First, Then LDP 0.4% n = 31	POS Vehicle First, Then LDP Vehicle n = 44
Value	60.5	30.0	45.2	27.3

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 9 days.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
POS 0.75% First, Then LDP 0.4%	0 of 44 (0%)	15 of 44 (34.1%)	0 of 44
POS 0.75% First, Then LDP Vehicle	0 of 30 (0%)	6 of 30 (20%)	0 of 30
POS Vehicle First, Then LDP 0.4%	0 of 31 (0%)	6 of 31 (19.4%)	0 of 31
POS Vehicle First, Then LDP Vehicle	0 of 45 (0%)	2 of 45 (4.4%)	0 of 45

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.
Individual participant dataSharing planned: No

Related trials for Presbyopia

Recruiting
Evaluation of Functional Superiority of the Morrow eProgressive
Presbyopia
Active, not recruiting
Clinical Trial With Artiflex Presbyopic (Artiplus)
Presbyopia, Ametropia
Recruiting
VisDura VisAbility™ Micro Insert System Pre-market Clinical Trial
Presbyopia
Recruiting
Volumetric Visual Fields at Intermediate and Near Distances in Presbyopic Patients Using Occupational and General-Purpose Progressive Addition Lenses
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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.

17 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Phentolamine Ophthalmic Solution 0.75% and Pilocarpine in people with Presbyopia, run by Opus Genetics, Inc at 17 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 4 inclusion and 23 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 17 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 2 Aug 2023). 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 (time frame: Visit 2 at 1 hour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04675151.

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.