A Phase 3 interventional study of 0.75% phentolamine ophthalmic solution and Placebo in Presbyopia, sponsored by Opus Genetics, Inc. Completed at 39 sites in United States. Open to participants aged 45 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Opus Genetics, Inc · Phase 3, Interventional, and Treatment
Safety and efficacy of POS in participants with presbyopia
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
336 studies on the registry are indexed under Presbyopia; 35 are open to participants now.
This study's enrollment of 569 is above the median of 61 across 276 interventional studies indexed under Presbyopia.
Browse Presbyopia studies →Opus Genetics, Inc is the lead sponsor of 17 studies on the registry; 4 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 13 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants must meet all of the following criteria:
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:
Exclusion Criteria:
Excluded from the study will be individuals with any of the following characteristics:
Ophthalmic (in either eye):
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: phentolamine ophthalmic solution 0.75%, a non-selective alpha-1 and alpha-2 adrenergic antagonist
Drug: 0.75% phentolamine ophthalmic solution
Drug: Placebo
Drug: Placebo
Once daily dosing
Also known as: Nyxol
Once daily dosing
Also known as: phentolamine ophthalmic solution vehicle
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).
Time frame: 8 Days
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.
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
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.
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
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.
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
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.
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
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
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
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.
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
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.
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
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.
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
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.
Time frame: 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.
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
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.
Time frame: 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.
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
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.
Time frame: 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.
Time frame: 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.
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
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.
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
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.
Time frame: 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.
Time frame: 6 Weeks
| Milestone | 0.75% Phentolamine Ophthalmic Solution | Phentolamine Ophthalmic Solution Vehicle |
|---|---|---|
| Started | 341 | 228 |
| Completed | 233 | 195 |
| Not completed | 108 | 33 |
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).
| Participants | 0.75% Phentolamine Ophthalmic Solution | Phentolamine Ophthalmic Solution Vehicle |
|---|---|---|
| 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) | 92 | 26 |
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.
| Participants | 0.75% Phentolamine Ophthalmic Solution | Phentolamine Ophthalmic Solution Vehicle |
|---|---|---|
| Day 1, 1 hour post-dose | 70 | 14 |
| Day 3 | 78 | 24 |
| Week 6 | 82 | 31 |
| Day 8 | 92 | 26 |
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.
| Participants | 0.75% Phentolamine Ophthalmic Solution | Phentolamine Ophthalmic Solution Vehicle |
|---|---|---|
| Day 1, 0.5 hours post-dose: ≥ 15 letters | 40 | 13 |
| Day 1, 1 hour post-dose: ≥ 15 letters | 71 | 15 |
| Day 3: ≥ 15 letters | 79 | 25 |
| Day 8: ≥ 15 letters | 92 | 27 |
| Week 6: ≥ 15 letters | 83 | 32 |
| Day 1, 0.5 hours post-dose: ≥ 10 letters | 99 | 51 |
| Day 1, 1-hour post-dose: ≥ 10 letters | 164 | 66 |
| Day 3: ≥ 10 letters | 166 | 63 |
| Day 8: ≥ 10 letters | 187 | 66 |
| Week 6: ≥ 10 letters | 163 | 77 |
| Day 1, 0.5 hours post-dose: ≥ 5 letters | 214 | 111 |
| Day 1, 1-hour post-dose: ≥ 5 letters | 257 | 136 |
| Day 3: ≥ 5 letters | 272 | 134 |
| Day 8: ≥ 5 letters | 280 | 142 |
| Week 6: ≥ 5 letters | 236 | 142 |
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.
| Participants | 0.75% Phentolamine Ophthalmic Solution | Phentolamine Ophthalmic Solution Vehicle |
|---|---|---|
| Day 1, 0.5 hours post-dose: ≥ 15 letters | 40 | 10 |
| Day 1, 1-hour post-dose: ≥ 15 letters | 62 | 21 |
| Day 3: ≥ 15 letters | 61 | 12 |
| Day 8: ≥ 15 letters | 78 | 23 |
| Week 6: ≥ 15 letters | 66 | 23 |
| Day 1, 0.5 hours post-dose: ≥ 10 letters | 96 | 38 |
| Day 1, 1-hour post-dose: ≥ 10 letters | 150 | 57 |
| Day 3: ≥ 10 letters | 152 | 54 |
| Day 8: ≥ 10 letters | 146 | 53 |
| Week 6: ≥ 10 letters | 133 | 58 |
| Day 1, 0.5 hours post-dose: ≥ 5 letters | 207 | 105 |
| Day 1, 1-hour post-dose: ≥ 5 letters | 260 | 130 |
| Day 3: ≥ 5 letters | 247 | 119 |
| Day 8: ≥ 5 letters | 252 | 123 |
| Week 6: ≥ 5 letters | 219 | 120 |
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.
| Letters Read | 0.75% Phentolamine Ophthalmic Solution | Phentolamine Ophthalmic Solution Vehicle |
|---|---|---|
| Day 1, 0.5 hours post-dose | 6.58 ± 0.32 | 4.50 ± 0.40 |
| Day 1, 1 hour post-dose | 8.96 ± 0.34 | 5.66 ± 0.41 |
| Day 3 | 9.38 ± 0.34 | 5.68 ± 0.42 |
| Day 8 | 10.10 ± 0.35 | 6.10 ± 0.42 |
| Week 6 | 10.48 ± 0.37 | 6.67 ± 0.43 |
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
| Letters Read | 0.75% Phentolamine Ophthalmic Solution | Phentolamine Ophthalmic Solution Vehicle |
|---|---|---|
| Day 1, 0.5 Hours Post-dose | 6.53 ± 0.33 | 4.59 ± 0.41 |
| Day 1, 1-Hour Post-dose | 8.68 ± 0.34 | 5.63 ± 0.42 |
| Day 3 | 8.62 ± 0.36 | 4.80 ± 0.44 |
| Day 8 | 9.01 ± 0.36 | 5.22 ± 0.44 |
| Week 6 | 9.29 ± 0.39 | 5.54 ± 0.46 |
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.
| Letters Read | 0.75% Phentolamine Ophthalmic Solution |
|---|---|
| Day 1, 0.5 hours post-dose | 6.6 ± 0.34 |
| Day 1, 1 hour post-dose | 9.0 ± 0.36 |
| Day 3 | 9.3 ± 0.35 |
| Day 8 | 10.0 ± 0.36 |
| Week 6 | 10.4 ± 0.36 |
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.
| Participants | 0.75% Phentolamine Ophthalmic Solution | Phentolamine Ophthalmic Solution Vehicle |
|---|---|---|
| Day 1, 0.5 hours post-dose: ≤ 20/15 | 3 | 0 |
| Day 1, 1 hour post-dose: ≤ 20/15 | 3 | 0 |
| Day 3 | 2 | 0 |
| Day 8 | 3 | 0 |
| Week 6 | 2 | 0 |
| Day 1, 0.5 hours post-dose: ≤ 20/20 | 9 | 2 |
| Day 1, 1-hour post-dose: ≤ 20/20 | 11 | 1 |
| Day 3: ≤ 20/20 | 10 | 2 |
| Day 8: ≤ 20/20 | 15 | 0 |
| Week 6: ≤ 20/20 | 11 | 5 |
| Day 1, 0.5 hours post-dose: ≤ 20/25 | 27 | 8 |
| Day 1, 1-hour post-dose: ≤ 20/25 | 48 | 10 |
| Day 3: ≤ 20/25 | 48 | 19 |
| Day 8: ≤ 20/25 | 59 | 20 |
| Week 6: ≤ 20/25 | 50 | 23 |
| Day 1, 0.5 hours post-dose: ≤ 20/32 | 73 | 34 |
| Day 1, 1-hour post-dose: ≤ 20/32 | 123 | 39 |
| Day 3: ≤ 20/32 | 132 | 43 |
| Day 8: ≤ 20/32 | 147 | 49 |
| Week 6: ≤ 20/32 | 125 | 57 |
| Day 1, 0.5 hours post-dose: ≤ 20/40 | 166 | 68 |
| Day 1, 1-hour post-dose: ≤ 20/40 | 211 | 91 |
| Day 3: ≤ 20/40 | 206 | 95 |
| Day 8: ≤ 20/40 | 228 | 99 |
| Week 6: ≤ 20/40 | 203 | 105 |
| Day 1, 0.5 hours post-dose: ≤ 20/50 | 261 | 155 |
| Day 1, 1-hour post-dose: ≤ 20/50 | 284 | 164 |
| Day 3: ≤ 20/50 | 292 | 165 |
| Day 8: ≤ 20/50 | 299 | 166 |
| Week 6: ≤ 20/50 | 261 | 165 |
| Day 1, 0.5 hours post-dose: ≤ 20/63 | 316 | 203 |
| Day 1, 1-hour post-dose: ≤ 20/63 | 324 | 209 |
| Day 3: ≤ 20/63 | 327 | 207 |
| Day 8: ≤ 20/63 | 326 | 207 |
| Week 6: ≤ 20/63 | 280 | 197 |
| Day 1, 0.5 hours post-dose: ≤ 20/80 | 338 | 224 |
| Day 1, 1-hour post-dose: ≤ 20/80 | 338 | 225 |
| Day 3: ≤ 20/80 | 336 | 222 |
| Day 8: ≤ 20/80 | 337 | 222 |
| Week 6: ≤ 20/80 | 283 | 211 |
| Day 1, 0.5 hours post-dose: ≤ 20/100 | 339 | 228 |
| Day 1, 1-hour post-dose: ≤ 20/100 | 340 | 228 |
| Day 3: ≤ 20/100 | 337 | 225 |
| Day 8: ≤ 20/100 | 338 | 225 |
| Week 6: ≤ 20/100 | 283 | 213 |
| Day 1, 0.5 hours post-dose: ≤ 20/125 | 340 | 228 |
| Day 1, 1-hour post-dose: ≤ 20/125 | 340 | 228 |
| Day 3: ≤ 20/125 | 337 | 225 |
| Day 8: ≤ 20/125 | 338 | 226 |
| Week 6: ≤ 20/125 | 283 | 215 |
| Day 1, 0.5 hours post-dose: ≤ 20/160 | 340 | 228 |
| Day 1, 1-hour post-dose: ≤ 20/160 | 340 | 228 |
| Day 3: ≤ 20/160 | 337 | 225 |
| Day 8: ≤ 20/160 | 338 | 226 |
| Week 6: ≤ 20/160 | 283 | 215 |
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.
| Participants | 0.75% Phentolamine Ophthalmic Solution | Phentolamine Ophthalmic Solution Vehicle |
|---|---|---|
| Day 8, ≤ 20/63 & ≥ 15 letters — ≥ 15 letters | 67 | 21 |
| Day 8, ≤ 20/80 & ≥ 15 letters — ≥ 15 letters | 86 | 26 |
| Day 8, ≤ 20/100 & ≥ 15 letters — ≥ 15 letters | 92 | 27 |
| Day 8, ≤ 20/125 & ≥ 15 letters — ≥ 15 letters | 92 | 27 |
| Day 8, ≤ 20/160 & ≥ 15 letters — ≥ 15 letters | 92 | 27 |
| Day 8, ≤ 20/63 & ≥ 10 letters — ≥ 15 letters | 150 | 53 |
| Day 8, ≤ 20/80 & ≥ 10 letters — ≥ 15 letters | 181 | 65 |
| Day 8, ≤ 20/100 & ≥ 10 letters — ≥ 15 letters | 187 | 66 |
| Day 8, ≤ 20/125 & ≥ 10 letters — ≥ 15 letters | 187 | 66 |
| Day 8, ≤ 20/160 & ≥ 10 letters — ≥ 15 letters | 187 | 66 |
| Day 8, ≤ 20/63 & ≥ 5 letters — ≥ 15 letters | 230 | 107 |
| Day 8, ≤ 20/80 & ≥ 5 letters — ≥ 15 letters | 271 | 136 |
| Day 8, ≤ 20/100 & ≥ 5 letters — ≥ 15 letters | 280 | 142 |
| Day 8, ≤ 20/125 & ≥ 5 letters — ≥ 15 letters | 280 | 142 |
| Day 8, ≤ 20/160 & ≥ 5 letters — ≥ 15 letters | 280 | 142 |
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.
| Participants | 0.75% Phentolamine Ophthalmic Solution | Phentolamine Ophthalmic Solution Vehicle |
|---|---|---|
| Day 1, 1-hour post-dose, ≥ 15 letters — ≥ 15 letters | 16 | 4 |
| Day 3: ≥ 15 letters — ≥ 15 letters | 22 | 3 |
| Day 8: ≥ 15 letters — ≥ 15 letters | 27 | 12 |
| Week 6: ≥ 15 letters — ≥ 15 letters | 27 | 19 |
| Day 1, 1-hour post-dose, ≥ 10 letters — ≥ 15 letters | 66 | 23 |
| Day 3: ≥ 10 letters — ≥ 15 letters | 90 | 36 |
| Day 8: ≥ 10 letters — ≥ 15 letters | 105 | 42 |
| Week 6: ≥ 10 letters — ≥ 15 letters | 84 | 40 |
| Day 1, 1-hour post-dose: ≥ 5 letters — ≥ 15 letters | 193 | 92 |
| Day 3: ≥ 5 letters — ≥ 15 letters | 206 | 97 |
| Day 8: ≥ 5 letters — ≥ 15 letters | 217 | 108 |
| Week 6: ≥ 5 letters — ≥ 15 letters | 189 | 99 |
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.
| Letters Read | 0.75% Phentolamine Ophthalmic Solution | Phentolamine Ophthalmic Solution Vehicle |
|---|---|---|
| Day 1, 1 hour post-dose | 4.89 ± 0.26 | 3.18 ± 0.31 |
| Day 3 | 5.84 ± 0.27 | 3.40 ± 0.33 |
| Day 8 | 6.40 ± 0.27 | 3.98 ± 0.33 |
| Week 6 | 6.43 ± 0.28 | 4.01 ± 0.34 |
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.
| Participants | 0.75% Phentolamine Ophthalmic Solution | Phentolamine Ophthalmic Solution Vehicle |
|---|---|---|
| Day 1, 1-hour post-dose: >= 15 Letters | 0 | 0 |
| Day 3: >= 15 Letters | 0 | 0 |
| Day 8: >= 15 Letters | 0 | 0 |
| Week 6: >= 15 Letters | 0 | 0 |
| Day 1, 1-hour post-dose: >= 10 Letters | 1 | 1 |
| Day 3: >= 10 Letters | 2 | 2 |
| Day 8: >= 10 Letters | 3 | 3 |
| Week 6: >= 10 Letters | 6 | 4 |
| Day 1, 1-hour post-dose: >= 5 Letters | 28 | 14 |
| Day 3: >= 5 Letters | 55 | 28 |
| Day 8: >= 5 Letters | 79 | 41 |
| Week 6: >= 5 Letters | 64 | 37 |
| Day 1, 1-hour post-dose: >= -4 to <= 4 Letters | 296 | 200 |
| Day 3: >= -4 to <= 4 Letters | 271 | 185 |
| Day 8: >= -4 to <= 4 Letters | 252 | 180 |
| Week 6: >= -4 to <= 4 Letters | 251 | 170 |
| Day 1, 1-hour post-dose: <= -5 Letters | 16 | 14 |
| Day 3: <= -5 Letters | 11 | 12 |
| Day 8: <= -5 Letters | 7 | 5 |
| Week 6: <= -5 Letters | 10 | 11 |
| Day 1, 1-hour post-dose: <= -10 Letters | 2 | 1 |
| Day 3: <= -10 Letters | 1 | 0 |
| Day 8: <= -10 Letters | 0 | 0 |
| Week 6: <= -10 Letters | 1 | 0 |
| Day 1, 1-hour post-dose: <= -15 Letters | 0 | 0 |
| Day 3: <= -15 Letters | 1 | 0 |
| Day 8: <= -15 Letters | 0 | 0 |
| Week 6: <= -15 Letters | 1 | 0 |
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.
| Letters Read | 0.75% Phentolamine Ophthalmic Solution | Phentolamine Ophthalmic Solution Vehicle |
|---|---|---|
| Day 1, 1 hour post-dose | 0.49 ± 0.17 | 0.13 ± 0.20 |
| Day 3 | 0.86 ± 0.19 | 0.64 ± 0.23 |
| Day 8 | 1.44 ± 0.18 | 1.30 ± 0.2 |
| Week 6 | 1.02 ± 0.20 | 0.83 ± 0.25 |
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.
| Letters Read | 0.75% Phentolamine Ophthalmic Solution | Phentolamine Ophthalmic Solution Vehicle |
|---|---|---|
| Day 1, 1 Hour Post-dose | 0.49 ± 0.17 | 0.13 ± 0.20 |
| Day 3 | 0.86 ± 0.19 | 0.64 ± 0.23 |
| Day 8 | 1.44 ± 0.18 | 1.30 ± 0.22 |
| Week 6 | 1.02 ± 0.20 | 0.83 ± 0.25 |
This outcome measure will investigate the change in pupil diameter from baseline at Day 3 and Day 8.
| millimeters | 0.75% Phentolamine Ophthalmic Solution | Phentolamine Ophthalmic Solution Vehicle |
|---|---|---|
| Day 3 | -1.17 ± 0.03 | -0.16 ± 0.04 |
| Day 8 | -1.17 ± 0.03 | -0.21 ± 0.04 |
This outcome measure will investigate the Percent Change in Pupil Diameter from Baseline at Day 3 \& Day 8.
| Percent Change | 0.75% Phentolamine Ophthalmic Solution | Phentolamine Ophthalmic Solution Vehicle |
|---|---|---|
| Day 3 | -24.51 ± 0.67 | -2.93 ± 0.82 |
| Day 8 | -24.48 ± 0.66 | -4.14 ± 0.81 |
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.
| Participants | 0.75% Phentolamine Ophthalmic Solution | Phentolamine Ophthalmic Solution Vehicle |
|---|---|---|
| Day 3: < 3.5 mm | 177 | 10 |
| Day 8: < 3.5 mm | 181 | 20 |
| Day 3: < 3.0 mm | 86 | 2 |
| Day 8: < 3.0 mm | 78 | 5 |
| Day 3: < 2.5 mm | 16 | 0 |
| Day 8: < 2.5 mm | 10 | 1 |
| Day 3: < 2.0 mm | 0 | 0 |
| Day 8: < 2.0 mm | 0 | 0 |
| Day 3: < 1.5 mm | 0 | 0 |
| Day 8: < 1.5 mm | 0 | 0 |
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.
| Participants | 0.75% Phentolamine Ophthalmic Solution | Phentolamine Ophthalmic Solution Vehicle |
|---|---|---|
| Day 3: 1.5 to < 2.0 mm | 0 | 0 |
| Day 8, 1.5 to < 2.0 mm | 0 | 0 |
| Day 3: 2.0 to < 2.5 mm | 16 | 0 |
| Day 8: 2.0 to < 2.5 mm | 10 | 1 |
| Day 3: 2.5 to < 3.0 mm | 70 | 2 |
| Day 8: 2.5 to < 3.0 mm | 68 | 4 |
| Day 3: 3.0 to < 3.5 mm | 91 | 8 |
| Day 8: 3.0 to < 3.5 mm | 103 | 15 |
| Day 3: 2.4 to ≤ 3.5 mm | 170 | 10 |
| Day 8: 2.4 to ≤ 3.5 mm | 175 | 19 |
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.
| Scores on a Scale | 0.75% Phentolamine Ophthalmic Solution | Phentolamine Ophthalmic Solution Vehicle |
|---|---|---|
| My study medication made my near vision | 3.63 ± 0.03 | 3.27 ± 0.04 |
| How convenient was it to use your study medication for your near vision | 4.13 ± 0.05 | 4.16 ± 0.06 |
| How frequently would you use the study medication if it were available to you | 4.29 ± 0.07 | 3.89 ± 0.09 |
| Day 8, How frequently would you use the study medication if it were available to you | 4.04 ± 0.08 | 3.62 ± 0.10 |
| How satisfied are you with how long the effects of the study medication lasted throughout the day | 3.39 ± 0.05 | 2.87 ± 0.06 |
| How satisfied are you with your study medication to help you see clearly up close when you | 3.26 ± 0.06 | 2.69 ± 0.07 |
| My study medication made my near vision in dim/low light | 3.45 ± 0.03 | 3.17 ± 0.04 |
| How frequently did you use some form of near vision correction? | 0.27 ± 0.05 | 0.09 ± 0.06 |
| How often did you need to use or do something to help you read small-sized text at a near distance? | 0.49 ± 0.05 | 0.30 ± 0.06 |
| How often did you need to use or do something to help you read information on a cell phone at a... | 0.37 ± 0.05 | 0.18 ± 0.06 |
| How often did you need to use or do something to help you read information on a computer screen... | 0.49 ± 0.06 | 0.43 ± 0.07 |
| How likely would you be to use the study medication for near vision correction? | 3.87 ± 0.07 | 3.49 ± 0.08 |
Collected over For enrollment until the end of study, up to 48 weeks. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 0.75% Phentolamine Ophthalmic Solution | 0/341 (0%) | 4/341 (1.2%) | 158/341 (46.3%) |
| Phentolamine Ophthalmic Solution Vehicle | 0/228 (0%) | 3/228 (1.3%) | 21/228 (9.2%) |
| Event | 0.75% Phentolamine Ophthalmic Solution | Phentolamine Ophthalmic Solution Vehicle |
|---|---|---|
| Encephalitis bacterialInfections and infestations | 0/341 | 1/228 |
| Rib fractureInjury, poisoning and procedural complications | 0/341 | 1/228 |
| Acute respiratory failureRespiratory, thoracic and mediastinal disorders | 0/341 | 1/228 |
| Intracranial aneurysmVascular disorders | 0/341 | 1/228 |
| Retinal vein occlusionEye disorders | 1/341 | 0/228 |
| CholecystitisHepatobiliary disorders | 1/341 | 0/228 |
| Septic shockInfections and infestations | 1/341 | 0/228 |
| Lung neoplasm malignantNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/341 | 0/228 |
| Metabolic encephalopathyNervous system disorders | 1/341 | 0/228 |
| Event | 0.75% Phentolamine Ophthalmic Solution | Phentolamine Ophthalmic Solution Vehicle |
|---|---|---|
| Conjunctival hyperaemiaEye disorders | 95/341 | 4/228 |
| Instillation site irritationGeneral disorders | 55/341 | 3/228 |
| Eye irritationEye disorders | 21/341 | 0/228 |
| DysgeusiaNervous system disorders | 20/341 | 1/228 |
| Eczema eyelidsEye disorders | 18/341 | 0/228 |
| Visual acuity reducedEye disorders | 12/341 | 11/228 |
| Instillation site erythemaGeneral disorders | 15/341 | 0/228 |
| Dry eyeEye disorders | 14/341 | 7/228 |
| Eye pruritusEye disorders | 12/341 | 2/228 |
| Conjunctivitis allergicEye disorders | 12/341 | 1/228 |
| Age, Continuous(Years) | 0.75% Phentolamine Ophthalmic Solution | Phentolamine Ophthalmic Solution Vehicle | Total |
|---|---|---|---|
| Mean | 54.3 ± 5.08 | 54.5 ± 4.91 | 54.4 ± 5.01 |
| Sex: Female, Male(Participants) | 0.75% Phentolamine Ophthalmic Solution | Phentolamine Ophthalmic Solution Vehicle | Total |
|---|---|---|---|
| Female | 229 | 148 | 377 |
| Male | 112 | 80 | 192 |
| Ethnicity (NIH/OMB)(Participants) | 0.75% Phentolamine Ophthalmic Solution | Phentolamine Ophthalmic Solution Vehicle | Total |
|---|---|---|---|
| Hispanic or Latino | 48 | 34 | 82 |
| Not Hispanic or Latino | 293 | 194 | 487 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | 0.75% Phentolamine Ophthalmic Solution | Phentolamine Ophthalmic Solution Vehicle | Total |
|---|---|---|---|
| American Indian or Alaska Native | 2 | 1 | 3 |
| Asian | 14 | 8 | 22 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 |
| Black or African American | 42 | 27 | 69 |
| White | 276 | 191 | 467 |
| More than one race | 6 | 1 | 7 |
| Unknown or Not Reported | 0 | 0 | 0 |
| BCDVA in the Study Eye(Letters) | 0.75% Phentolamine Ophthalmic Solution | Phentolamine Ophthalmic Solution Vehicle | Total |
|---|---|---|---|
| Mean | 57.9 ± 3.01 | 58.1 ± 3.36 | 58 ± 3.15 |
| BCDVA Binocular(Letters) | 0.75% Phentolamine Ophthalmic Solution | Phentolamine Ophthalmic Solution Vehicle | Total |
|---|---|---|---|
| Mean | 59.4 ± 3.29 | 59.7 ± 3.74 | 59.5 ± 3.48 |
| DCNVA Binocular(Letters) | 0.75% Phentolamine Ophthalmic Solution | Phentolamine Ophthalmic Solution Vehicle | Total |
|---|---|---|---|
| Mean | 47.2 ± 3.51 | 46.9 ± 3.96 | 47.1 ± 3.70 |
| DCNVA in the Study Eye(Letters) | 0.75% Phentolamine Ophthalmic Solution | Phentolamine Ophthalmic Solution Vehicle | Total |
|---|---|---|---|
| Mean | 43.1 ± 4.31 | 43.7 ± 4.41 | 43.4 ± 4.36 |
11 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
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Studies of the drug tested here: Phentolamine
Opus Genetics, Inc