PresbyopiaPhase 3VEGA-3NCT06542497
Evaluate Efficacy and Safety of POS to Improve Distance-corrected Near Visual in Participants With Presbyopia
A Phase 3 study testing 0.75% phentolamine ophthalmic solution in people with Presbyopia, run by Opus Genetics, Inc at 39 sites in United States.
Trial summary
Safety and efficacy of POS in participants with presbyopia Read more about this study
- Who is it for?
- Ages 45 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Presbyopia
- What is being tested?
- 0.75% phentolamine ophthalmic solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 569 participants
- Where
- 39 sitesUnited States
- Study dates
- 15 Aug 2024to 22 Jan 2026
- 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 45 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must meet all of the following criteria:
- Males or females ≥ 45 and ≤ 64 years of age
- Able to comply with all protocol-mandated procedures independently and to attend all scheduled office visits
- Able and willing to give signed informed consent
- Able to self-administer study medication throughout the study period
- Inclusion criteria #5, #6, and #7 must all be met at both Screening and Baseline Visits:
Show all 10Show fewer
- BCDVA of 55 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (20/20 Snellen equivalent) or better in photopic conditions in each eye
- DCNVA of 50 ETDRS letters (20/50 Snellen equivalent) or worse but not <35 ETDRS letters (20/100 Snellen equivalent) in photopic conditions in each eye and binocularly
- For participants who depend on reading glasses or bifocals, binocular best-corrected near VA of 65 ETDRS letters (20/25 Snellen equivalent) or better
- Photopic PD of ≥ 4 mm in the study eye at Screening
Who cannot join
- Excluded from the study will be individuals with any of the following characteristics:
- Ophthalmic (in either eye):
- Use of any topical prescription (including Vuity® or Qlosi™) 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 (eg, OCuSOFT® lid scrub, SteriLid®, baby shampoo, etc.) and artificial tears as specified in Exclusion Criterion #2 below
- Use of any OTC artificial tears (preserved or unpreserved) during visit days or 15 min before or after instillation of study medication
- Use of Ryzumvi™ (POS) within 7 days prior to Screening
- Use of any dry eye product, such as topical ophthalmic therapy for dry eye (eg, generic cyclosporine, Restasis®, Xiidra®, Cequa®, Eysuvis®, and Meibo®) or intranasal dry eye product (eg, Tyrvaya®) or other devices within 12 months prior to Screening
Show all 28Show fewer
- Tear break-up time of < 5 seconds or corneal fluorescein staining (CFS) Grade ≥ 2 in the inferior zone or Grade ≥ 1 in the central zone using the National Eye Institute scale
- Clinically significant ocular disease (eg, cataract, glaucoma, corneal edema, uveitis, retinal degeneration, loss of visual field, or any macular pathology) that, in the judgment of the Investigator, might interfere with study procedures
- Recent or current evidence of ocular infection or inflammation in either eye (such as current evidence of clinically significant blepharitis, conjunctivitis, keratitis, etc.). Participants must be symptom free for at least 7 days prior to Screening
- Any history of herpes simplex or herpes zoster keratitis
- Known allergy, hypersensitivity, or contraindication to any component of the phentolamine or vehicle formulations
- Prior participation in a study involving the use of POS for the treatment of presbyopia or night vision disturbance
- 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. Any history of radial keratotomy is prohibited
- Participants with surgical monovision, multifocal, or extended depth-of-focus intraocular lenses (IOLs). Monofocal IOLs are acceptable if in place > 6 months prior to Screening
- Monofocal IOL in place > 6 months prior to Screening with any posterior capsule opacification
- History of any traumatic (surgical or nonsurgical) or nontraumatic condition affecting the pupil or iris (eg, irregularly shaped pupil, neurogenic pupil disorder, iris atrophy, iridotomy, iridectomy, iritis, etc.)
- Unwilling or unable to discontinue use of contact lenses at least 1 hour prior to Screening for soft contact lenses or at least 8 hours prior to Screening for hard gas permeable contact lenses, and at least 8 hours (for both types of lenses) prior to all other office visits
- Systemic:
- Known hypersensitivity or contraindication to alpha- and/or beta-adrenoceptor antagonists (eg, chronic obstructive pulmonary disease or bronchial asthma; abnormally low blood pressure (BP) or heart rate (HR); second- or third-degree heart blockage or congestive heart failure)
- Known hypersensitivity or contraindication to any systemic cholinergic parasympathomimetic agent
- Clinically significant systemic disease (eg, uncontrolled diabetes, myasthenia gravis, cancer, hepatic, renal, endocrine, or cardiovascular disorders) 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; however, Flomax® (tamsulosin) is specifically excluded
- 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. Acceptable methods include the use of at least one of the following: intrauterine device, hormonal contraception (oral, injection, patch, implant, ring), barrier with spermicide (condom, diaphragm), or abstinence. A female is considered to be of childbearing potential unless she is 1 year postmenopausal or 3 months post-surgical sterilization. All females of childbearing potential, including those with post-tubal ligation, must have a negative urine pregnancy test result at Visit 1 (Screening)
- Resting HR outside the range of 50 to 110 beats per min (bpm) following at least a 5 min rest period in the sitting position at Visit 1 (Screening). HR may be repeated only once if outside the specified range, following another 5 min rest period in the sitting position
- Hypertension with resting diastolic BP > 105 mmHg or systolic BP > 160 mmHg following at least a 5-min rest period in the sitting position at Visit 1 (Screening). BP may be repeated only once if outside the specified range, following another 5-min rest period in the sitting position
Trial locations and contacts
39 sites in 1 country.
39 sites in 1 country
United States39 sites
Athens Eye Care
Athens, Ohio, 45701
Empire Eye & Laser Center
Bakersfield, California, 93309
Arizona Eye Center
Chandler, Arizona, 85224
Segal Drug Trials, Inc.
Delray Beach, Florida, 33484
South Florida Glaucoma
Delray Beach, Florida, 33484
Bergstrom Eye
Fargo, North Dakota, 58103
Red River Research Partners
Fargo, North Dakota, 58103
Fraser Eye Care Center
Fraser, Michigan, 48026
Oculus Research , Inc.
Garner, North Carolina, 27529
Global Research Management, Inc.
Glendale, California, 91204
Advancing Vision Research
Goodlettsville, Tennessee, 37072
Whitsett Vision Group
Houston, Texas, 77055
Price Vision Group
Indianapolis, Indiana, 46260
Levenson Eye
Jacksonville, Florida, 32204
Bowden Eye & Associates
Jacksonville, Florida, 32256
Moyes Eye Center
Kansas City, Missouri, 64154
Gordon Schanzlin New Vision Institute
La Jolla, California, 92307
Lake Travis Eye and Laser Center/ Revolution Research
Lakeway, Texas, 78738
Shettle Eye Research
Largo, Florida, 33773
Sabal Eye Care/dba Omega Vision Center
Longwood, Florida, 32779
The Eye Care Institute
Louisville, Kentucky, 40206
Optometry Group
Memphis, Tennessee, 38111
Total Eye Care
Memphis, Tennessee, 38119
Carrot Eye Center
Mesa, Arizona, 85202
Mid Florida Eye Center
Mt. Dora, Florida, 32757
LoBue Laser and Eye Medical Center, Inc.
Murrieta, California, 92562
Eye Research Foundation
Newport Beach, California, 92663
Durrie Vision
Overland Park, Kansas, 66210
Eye Doctors of Arizona
Phoenix, Arizona, 85028
Kannarr Eye Care
Pittsburg, Kansas, 66762
Red River Research Partners
Richardson, Texas, 75080
Rochester Ophthalmological Group
Rochester, New York, 14618
Virdi Eye Clinic
Rock Island, Illinois, 61201
Eye Institute of Utah
Salt Lake City, Utah, 84107
Parkhurst NuVision
San Antonio, Texas, 78229
MRB Eye Care Consultants, LLC
Scottsdale, Arizona, 85260
Heart of America Eye Care, P.A.
Shawnee Mission, Kansas, 66204
Wolstan and Goldberg Eye Associates
Torrance, California, 90505
West Bay Eye Associates
Warwick, Rhode Island, 02888
About this study
Official title: Randomized, Double-masked, Placebo-controlled, Multicenter Study of the Efficacy and Safety of Phentolamine Ophthalmic Solution (POS) 0.75% in Participants With Presbyopia
Safety and efficacy of POS in participants with presbyopia
Read the detailed description
Randomized, Double-Masked, Placebo-Controlled, Multicenter, Phase 3 Study of the Efficacy and Safety of Phentolamine Ophthalmic Solution (POS) 0.75% in Participants with Presbyopia
- Conditions
- Presbyopia
- Being tested
- 0.75% phentolamine ophthalmic solution, Placebo
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.75% phentolamine ophthalmic solutionDrug
Also called Nyxol
Once daily dosing
PlaceboDrug
Also called phentolamine ophthalmic solution vehicle
Once daily dosing
| Study group | Role | What they receive |
|---|---|---|
| 0.75% phentolamine ophthalmic solution | Active comparator | Drug: phentolamine ophthalmic solution 0.75%, a non-selective alpha-1 and alpha-2 adrenergic antagonist Receives: Drug: 0.75% phentolamine ophthalmic solution |
| phentolamine ophthalmic solution vehicle | Placebo comparator | Drug: Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects With ≥ 15 Letters of Improvement in Binocular DCNVA and With < 5 Letters of Loss in Binocular BCDVA From Baseline Comparing POS-treated Participants to Placebo-treated Participants at 12 Hours Post-dose at Visit 4 (Day 8)
The primary efficacy endpoint is the percentage of participants with ≥ 15 letters of improvement in binocular DCNVA and with < 5 letters of loss in binocular BCDVA from baseline comparing POS-treated participants to placebo-treated participants at 12 hours post-dose at Visit 4 (Day 8).
Measured: 8 Days
Secondary outcomes (18)
Percentage of Subjects With ≥ 15 Letters of Improvement in Binocular DCNVA and With < 5 Letters of Loss in Binocular BCDVA From Baseline at Day 1 (1-hour Post-dose), Day 3, and Week 6
This secondary efficacy endpoint is the percentage of participants with ≥ 15 letters of improvement in binocular DCNVA and with < 5 letters of loss in binocular BCDVA from baseline comparing POS-treated participants to placebo-treated participants at 12 hours post-dose at Day 1 (1-hour post-dose), Day 3, and Week 6.
Measured: 6 Weeks
Percentage of Subjects With ≥ 5, ≥ 10, and ≥ 15 Letters of Improvement in DCNVA From Baseline (Binocular) at Day 1 (0.5 Hours and 1 Hour Post-dose), Day 3, Day 8, and Week 6
The percentage of Subjects With ≥ 5, ≥ 10, and ≥ 15 Letters of Improvement in DCNVA From Baseline (Monocular and Binocular) at Day 1 (0.5 hours and 1 hour post-dose), Day 3, Day 8, and Week 6.
Measured: 6 Weeks
Percentage of Subjects With ≥ 5, ≥ 10, and ≥ 15 Letters of Improvement in DCNVA From Baseline (Monocular - Study Eye) at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
This outcome measure will investigate the percentage of subjects with ≥ 5, ≥ 10, and ≥ 15 letters of improvement in DCNVA from baseline (monocular - study eye) at Day 1 (0.5 hours and 1-hour post-dose), Day 3, Day 8, and Week 6.
Measured: 6 Weeks
Change in DCNVA From Baseline (Binocular) at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
This outcome measure will investigate the change in DCNVA from baseline (binocular) at Day 1 (0.5 hours and 1-hour post-dose), Day 3, Day 8, and Week 6.
Measured: 6 Weeks
Change in DCNVA From Baseline (Monocular - Study Eye) at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
This outcome measure will investigate the Change in DCNVA From Baseline (Monocular - Study Eye) at Day 1 (0.5 hours and 1-hour post-dose), Day 3, Day 8, and Week 6
Measured: 6 Weeks
Change in Mean Binocular DCNVA From Baseline at Week 6 Compared to the Best Prior Observed Change From Baseline in Mean Binocular DCNVA in Subjects Treated With POS
This outcome measure investigates the change in mean binocular DCNVA from baseline at Week 6 compared to the best prior observed change from baseline in mean binocular DCNVA in subjects treated with POS.
Measured: 6 Weeks
Percentage of Subjects With DCNVA ≤ 20/15, ≤ 20/20, ≤ 20/25, ≤ 20/32, ≤ 20/40, ≤ 20/50, ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
This outcome measure will investigate the percentage of subjects with DCNVA ≤ 20/15, ≤ 20/20, ≤ 20/25, ≤ 20/32, ≤ 20/40, ≤ 20/50, ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 at Day 1 (0.5 hours and
1-hour post-dose), Day 3, Day 8, and Week 6.
Measured: 6 Weeks
Percentage of Subjects With Baseline DCNVA ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 With a ≥ 10-Letter and ≥ 15-Letter Improvement in DCNVA at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
This outcome measure will investigate the percentage of subjects with baseline DCNVA ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 with a ≥ 10-Letter and ≥ 15-Letter Improvement in DCNVA at Day 1 (0.5 hours and 1-hour post-dose), Day 3, Day 8, and Week 6.
Measured: 6 Weeks
Percentage of Subjects With ≥ 5, ≥ 10, and ≥ 15 Letters of Improvement in Binocular DCIVA From Baseline at Day 1 (1-hour Post-dose), Day 3, Day 8, and Week 6
This outcome measure will investigate the percentage of subjects with ≥ 5, ≥ 10, and ≥ 15 letters of improvement in binocular DCIVA from baseline at Day 1 (1-hour post-dose), Day 3, Day 8, and Week 6.
Measured: 6 Weeks
Change in Binocular DCIVA From Baseline at Day 1 (1-hour Post-dose), Day 3, Day 8, and Week 6
This outcome measure will investigate the change in binocular DCIVA from baseline at Day 1 (1-hour post-dose), Day 3, Day 8, and Week 6.
Measured: 6 Weeks
Percentage of Subjects With Loss or Improvement in BCDVA From Baseline (Binocular) at Day 1 (1-hour Post-dose), Day 3, Day 8, and Week 6
This outcome measure will investigate the percentage of subjects with loss or improvement in BCDVA from baseline (Binocular) at Day 1 (1-hour post-dose), Day 3, Day 8, and Week 6.
Measured: 6 Weeks
Change in BCDVA From Baseline (Binocular) at Day 1 (1-hour Post-dose), Day 3, Day 8, and Week 6
This outcome measure will investigate the change in BCDVA from baseline (Binocular) at Day 1 (1-hour post-dose), Day 3, Day 8, and Week 6.
Measured: 6 Weeks
Change in BCDVA From Baseline (Monocular - Study Eye) at Day 1 (1-hour Post-dose), Day 3, Day 8, and Week 6
This outcome measure will investigate the Change in BCDVA From Baseline (Monocular - Study Eye) at Day 1 (1-hour post-dose), Day 3, Day 8, and Week 6.
Measured: 6 Weeks
Change in Pupil Diameter From Baseline at Day 3 and Day 8
This outcome measure will investigate the change in pupil diameter from baseline at Day 3 and Day 8.
Measured: 8 Days
Percent Change in Pupil Diameter From Baseline at Day 3 & Day 8
This outcome measure will investigate the Percent Change in Pupil Diameter from Baseline at Day 3 \& Day 8.
Measured: 8 Days
Percentage of Subjects With Pupil Diameter of < 3.5, < 3.0, < 2.5, < 2.0, and < 1.5 mm at Day 3 and Day 8
This outcome measure will investigate the percentage of subjects with pupil diameter of < 3.5, < 3.0, < 2.5, < 2.0, and < 1.5 mm at Day 3 and Day 8.
Measured: 8 Days
Percentage of Subjects With Pupil Diameter of 1.5 to < 2.0 mm, 2.0 to < 2.5 mm, 2.5 to < 3.0 mm, and 3.0 to < 3.5 mm at Day 3 and Day 8
This outcome measure will investigate the percentage of subjects with pupil diameter of 1.5 to < 2.0 mm, 2.0 to < 2.5 mm, 2.5 to < 3.0 mm, and 3.0 to < 3.5 mm at Day 3 and Day 8.
Measured: 8 Days
Change From Baseline in Overall and Component Subject-Reported Outcomes at Day 3, Day 8, and Week 6
This outcome measure investigates the change from baseline in overall and component subject-reported outcomes at Day 3, Day 8, and Week 6. : Responses to each question used a 1-5 scale with 1=Worst outcome and 5=Best outcome.
Measured: 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start15 Aug 2024
- Primary completion3 Apr 2025
- Study completion22 Jan 2026
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
- Model description
- Parallel assignment
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 569 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
- NCT06542497
- Sponsor's protocol ID
- OPI-NYXP-302 (VEGA-3)
- Acronym
- VEGA-3
- Status last verified
- Oct 2026
- First submitted
- 5 Aug 2024
- Last updated
- 26 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-masked, Placebo-controlled, Multicenter Study of the Efficacy and Safety of Phentolamine Ophthalmic Solution (POS) 0.75% in Participants With Presbyopia
- ClinicalTrials.gov ID
- NCT06542497
- Acronym / sponsor ID
- VEGA-3 / OPI-NYXP-302 (VEGA-3)
- Conditions
- Presbyopia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 569 participants (actual)
- Lead sponsor
- Opus Genetics, IncIndustry (pharma, biotech, devices)
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 3 Apr 2025 (actual)
- Study completion
- 22 Jan 2026 (actual)
- First posted
- 7 Aug 2024 (actual)
- Results
- Posted 17 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Safety and efficacy of POS in participants with presbyopia
Detailed description
Randomized, Double-Masked, Placebo-Controlled, Multicenter, Phase 3 Study of the Efficacy and Safety of Phentolamine Ophthalmic Solution (POS) 0.75% in Participants with Presbyopia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| 0.75% phentolamine ophthalmic solution | Active comparator | Drug: 0.75% phentolamine ophthalmic solutionDrug: phentolamine ophthalmic solution 0.75%, a non-selective alpha-1 and alpha-2 adrenergic antagonist |
| phentolamine ophthalmic solution vehicle | Placebo comparator | Drug: PlaceboDrug: Placebo |
Who may qualify
- Ages
- 45 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Males or females ≥ 45 and ≤ 64 years of age
- Able to comply with all protocol-mandated procedures independently and to attend all scheduled office visits
- Able and willing to give signed informed consent
- Able to self-administer study medication throughout the study period
- BCDVA of 55 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (20/20 Snellen equivalent) or better in photopic conditions in each eye
Key exclusion criteria (28 listed)
- Use of any topical prescription (including Vuity® or Qlosi™) 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 (eg, OCuSOFT® lid scrub, SteriLid®, baby shampoo, etc.) and artificial tears as specified in Exclusion Criterion #2 below
- Use of any OTC artificial tears (preserved or unpreserved) during visit days or 15 min before or after instillation of study medication
- Use of Ryzumvi™ (POS) within 7 days prior to Screening
- Use of any dry eye product, such as topical ophthalmic therapy for dry eye (eg, generic cyclosporine, Restasis®, Xiidra®, Cequa®, Eysuvis®, and Meibo®) or intranasal dry eye product (eg, Tyrvaya®) or other devices within 12 months prior to Screening
- Tear break-up time of < 5 seconds or corneal fluorescein staining (CFS) Grade ≥ 2 in the inferior zone or Grade ≥ 1 in the central zone using the National Eye Institute scale
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 |
|---|---|---|
| 0.75% phentolamine ophthalmic solutionAlso: NyxolOnce daily dosing | Drug | 0.75% phentolamine ophthalmic solution |
| PlaceboAlso: phentolamine ophthalmic solution vehicleOnce daily dosing | Drug | phentolamine ophthalmic solution vehicle |
Primary outcome
Percentage of Subjects With ≥ 15 Letters of Improvement in Binocular DCNVA and With < 5 Letters of Loss in Binocular BCDVA From Baseline Comparing POS-treated Participants to Placebo-treated Participants at 12 Hours Post-dose at Visit 4 (Day 8)
Time frame: 8 Days
The primary efficacy endpoint is the percentage of participants with ≥ 15 letters of improvement in binocular DCNVA and with < 5 letters of loss in binocular BCDVA from baseline comparing POS-treated participants to placebo-treated participants at 12 hours post-dose at Visit 4 (Day 8).
18 secondary outcomes
Percentage of Subjects With ≥ 15 Letters of Improvement in Binocular DCNVA and With < 5 Letters of Loss in Binocular BCDVA From Baseline at Day 1 (1-hour Post-dose), Day 3, and Week 6
Time frame: 6 Weeks
Percentage of Subjects With ≥ 5, ≥ 10, and ≥ 15 Letters of Improvement in DCNVA From Baseline (Binocular) at Day 1 (0.5 Hours and 1 Hour Post-dose), Day 3, Day 8, and Week 6
Time frame: 6 Weeks
Percentage of Subjects With ≥ 5, ≥ 10, and ≥ 15 Letters of Improvement in DCNVA From Baseline (Monocular - Study Eye) at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Time frame: 6 Weeks
Change in DCNVA From Baseline (Binocular) at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Time frame: 6 Weeks
Change in DCNVA From Baseline (Monocular - Study Eye) at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Time frame: 6 Weeks
Change in Mean Binocular DCNVA From Baseline at Week 6 Compared to the Best Prior Observed Change From Baseline in Mean Binocular DCNVA in Subjects Treated With POS
Time frame: 6 Weeks
Percentage of Subjects With DCNVA ≤ 20/15, ≤ 20/20, ≤ 20/25, ≤ 20/32, ≤ 20/40, ≤ 20/50, ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Time frame: 6 Weeks
Percentage of Subjects With Baseline DCNVA ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 With a ≥ 10-Letter and ≥ 15-Letter Improvement in DCNVA at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Time frame: 6 Weeks
Percentage of Subjects With ≥ 5, ≥ 10, and ≥ 15 Letters of Improvement in Binocular DCIVA From Baseline at Day 1 (1-hour Post-dose), Day 3, Day 8, and Week 6
Time frame: 6 Weeks
Change in Binocular DCIVA From Baseline at Day 1 (1-hour Post-dose), Day 3, Day 8, and Week 6
Time frame: 6 Weeks
Percentage of Subjects With Loss or Improvement in BCDVA From Baseline (Binocular) at Day 1 (1-hour Post-dose), Day 3, Day 8, and Week 6
Time frame: 6 Weeks
Change in BCDVA From Baseline (Binocular) at Day 1 (1-hour Post-dose), Day 3, Day 8, and Week 6
Time frame: 6 Weeks
Change in BCDVA From Baseline (Monocular - Study Eye) at Day 1 (1-hour Post-dose), Day 3, Day 8, and Week 6
Time frame: 6 Weeks
Change in Pupil Diameter From Baseline at Day 3 and Day 8
Time frame: 8 Days
Percent Change in Pupil Diameter From Baseline at Day 3 & Day 8
Time frame: 8 Days
Percentage of Subjects With Pupil Diameter of < 3.5, < 3.0, < 2.5, < 2.0, and < 1.5 mm at Day 3 and Day 8
Time frame: 8 Days
Percentage of Subjects With Pupil Diameter of 1.5 to < 2.0 mm, 2.0 to < 2.5 mm, 2.5 to < 3.0 mm, and 3.0 to < 3.5 mm at Day 3 and Day 8
Time frame: 8 Days
Change From Baseline in Overall and Component Subject-Reported Outcomes at Day 3, Day 8, and Week 6
Time frame: 6 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
39 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 0.75% phentolamine ophthalmic solution in people with Presbyopia, run by Opus Genetics, Inc at 39 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 10 inclusion and 28 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 26 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 39 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 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 17 Aug 2026). 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?
Percentage of Subjects With ≥ 15 Letters of Improvement in Binocular DCNVA and With < 5 Letters of Loss in Binocular BCDVA From Baseline Comparing POS-treated Participants to Placebo-treated Participants at 12 Hours Post-dose at Visit 4 (Day 8) (time frame: 8 Days). 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 26 Oct 2026.