Dilation, Mydriasis
Conditions
Keywords
Nyxol, Pharmacologically Induced Mydriasis, Dilation
Brief summary
The objectives of this study are: * To evaluate the efficacy of Nyxol to expedite the reversal of pharmacologically-induced mydriasis across multiple mydriatic agents with an emphasis on phenylephrine * To evaluate the efficacy of Nyxol to return subjects to baseline accommodation after worsening (with cycloplegic agents tropicamide and Paremyd) * To evaluate the safety of Nyxol * To evaluate any additional benefits of the reversal of pharmacologically-induced mydriasis
Detailed description
A randomized, parallel arm, double-masked, placebo-controlled Phase 3 study in at least 168 randomized subjects (160 completed), evaluating the safety and efficacy of Nyxol in subjects with pharmacologically-induced mydriasis. Following the successful completion of screening, each subject will be stratified by eye color and then simultaneously be randomized to mydriatic agent (unmasked) and treatment (masked). Treatment randomization will be 1:1, Nyxol or placebo (vehicle). Stratification by iris color will be 1:1, light or dark irides. The mydriatic agent randomization will be 3:1:1 (2.5% phenylephrine, 1% tropicamide, and Paremyd). That is, approximately 60% of the randomized subjects will receive one drop of 2.5% phenylephrine 1 hour before treatment (96 completed subjects), approximately 20% will receive one drop of 1% tropicamide 1 hour before treatment (32 completed subjects), and approximately 20% will receive Paremyd 1 hour before treatment (32 completed subjects). At the treatment visit, subjects who have been randomized and stratified by iris color (1:1 \[light/dark\]) will receive one of three approved mydriatic agents approximately 1 hour prior to receiving study treatment. Measurements will be measured before (-1 hour /baseline) and 60 minutes after (maximum/0 minutes) the mydriatic agent instillation in each eye (i.e. right before the study treatment is administered), and at 30 minutes, 60 minutes, 90 minutes, 2 hours, 3 hours, 4 hours, and 6 hours after treatment dosing. Measurements will include pupil diameter (PD), distance and near visual acuity (VA), accommodation, and redness in each eye. At the Follow-Up Visit, which is 1 day after Visit 1, measurements will again be recorded 24 hours after treatment dosing.
Interventions
0.75% phentolamine ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist
Topical sterile ophthalmic solution
Sponsors
Ocuphire Pharma, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Males or females ≥ 12 years of age 2. Otherwise healthy and well controlled subjects
Exclusion criteria
Ophthalmic (in either eye): 1. Clinically significant ocular disease as deemed by the Investigator that might interfere with the study 2. Unwilling or unable to discontinue use of contact lenses at screening until study completion 3. Unwilling or unable to suspend use of topical medication at screening until study completion 4. Ocular trauma, ocular surgery or non-refractive laser treatment within the 6 months prior to screening 5. Use of any topical prescription or over-the-counter (OTC) ophthalmic medications of any kind within 7 days of screening 6. Recent or current evidence of ocular infection or inflammation in either eye 7. History of diabetic retinopathy or diabetic macular edema 8. Closed or very narrow angles that in the Investigator's opinion are potentially occludable if the subject's pupil is dilated 9. History of any traumatic (surgical or nonsurgical) or non-traumatic condition affecting the pupil or iris 10. Known allergy or contraindication to any component of the mydriatic agents or the vehicle formulation 11. History of cauterization of the punctum or punctal plug (silicone or collagen) insertion or removal Systemic: 1. Known hypersensitivity or contraindication to α- and/or β adrenoceptor antagonists. 2. Clinically significant systemic disease that might interfere with the study 3. 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 4. Participation in any investigational study within 30 days prior to screening 5. Females of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control 6. Resting HR outside the normal range (50-110 beats per minute) 7. Hypertension with resting diastolic BP \> 105 mmHg or systolic BP \> 160 mmHg
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Subjects' Study Eyes With Pupil Diameter Returning to Baseline | 90 minutes | Percentage of subjects' study eyes returning to less than or equal to 0.2 mm from baseline pupil diameter |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Subjects' Study Eyes Pupil Diameter Returning to Baseline | up to 24 hours | Percentage of subjects' study eyesreturning to less than or equal to 0.2 mm from baseline pupil diameter |
| Pupil Diameter (Change From Max) | up to 24 hours | Change (mm) from maximum pharmacologically-induced mydriatic pupil diameter (0 minutes) |
| Percent of Subjects With Unchanged Accommodation From Baseline | up to 6 hours | Percentage of subjects with unchanged accommodation from baseline (-1 hour) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Phentolamine Ophthalmic Solution 0.75% 2 drops in study eye and 1 drop in non-study eye, 1 hour post pharmacologically-induced mydriasis
Phentolamine Ophthalmic Solution 0.75%: 0.75% phentolamine ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist | 94 |
| Phentolamine Ophthalmic Solution Vehicle 2 drops in study eye and 1 drop in non-study eye, 1 hour post pharmacologically-induced mydriasis
Phentolamine Ophthalmic Solution Vehicle (Placebo): Topical sterile ophthalmic solution | 91 |
| Total | 185 |
Baseline characteristics
| Characteristic | Phentolamine Ophthalmic Solution 0.75% | Phentolamine Ophthalmic Solution Vehicle | Total |
|---|---|---|---|
| Age, Continuous | 33.9 years STANDARD_DEVIATION 14.04 | 32.8 years STANDARD_DEVIATION 13.55 | 33.4 years STANDARD_DEVIATION 13.77 |
| Baseline Accomodation (Study Eye) | 10.47 D STANDARD_DEVIATION 20.373 | 8.25 D STANDARD_DEVIATION 5.23 | 9.38 D STANDARD_DEVIATION 14.98 |
| Baseline BCDVA (Study Eye) | 57.0 Letters STANDARD_DEVIATION 4.1 | 58.6 Letters STANDARD_DEVIATION 4.49 | 57.8 Letters STANDARD_DEVIATION 4.36 |
| Baseline DCNVA | 65.6 Letters STANDARD_DEVIATION 10.63 | 67.0 Letters STANDARD_DEVIATION 9.74 | 66.3 Letters STANDARD_DEVIATION 10.2 |
| Baseline IOP (Study Eye) | 15.3 mmHg STANDARD_DEVIATION 2.78 | 15.1 mmHg STANDARD_DEVIATION 2.95 | 15.2 mmHg STANDARD_DEVIATION 2.85 |
| Baseline Pupil Diameter (Study Eye) | 5.085 mm STANDARD_DEVIATION 0.9295 | 5.177 mm STANDARD_DEVIATION 0.9678 | 5.130 mm STANDARD_DEVIATION 0.9471 |
| Irides Type: Light, Dark Dark | 49 Participants | 46 Participants | 95 Participants |
| Irides Type: Light, Dark Light | 45 Participants | 45 Participants | 90 Participants |
| Mydriatic Agent Paremyd | 19 Participants | 18 Participants | 37 Participants |
| Mydriatic Agent Phenylephrine | 56 Participants | 55 Participants | 111 Participants |
| Mydriatic Agent Tropicamide | 19 Participants | 18 Participants | 37 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian | 6 Participants | 3 Participants | 9 Participants |
| Race/Ethnicity, Customized Black or African American | 17 Participants | 16 Participants | 33 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 70 Participants | 74 Participants | 144 Participants |
| Sex: Female, Male Female | 58 Participants | 55 Participants | 113 Participants |
| Sex: Female, Male Male | 36 Participants | 36 Participants | 72 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 94 | 0 / 91 |
| other Total, other adverse events | 48 / 94 | 8 / 91 |
| serious Total, serious adverse events | 0 / 94 | 0 / 91 |
Outcome results
Primary
Percent of Subjects' Study Eyes With Pupil Diameter Returning to Baseline
Percentage of subjects' study eyes returning to less than or equal to 0.2 mm from baseline pupil diameter
Time frame: 90 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phentolamine Ophthalmic Solution 0.75% | Percent of Subjects' Study Eyes With Pupil Diameter Returning to Baseline | 46 Participants |
| Phentolamine Ophthalmic Solution Vehicle | Percent of Subjects' Study Eyes With Pupil Diameter Returning to Baseline | 6 Participants |
Secondary
Percent of Subjects' Study Eyes Pupil Diameter Returning to Baseline
Percentage of subjects' study eyesreturning to less than or equal to 0.2 mm from baseline pupil diameter
Time frame: up to 24 hours
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phentolamine Ophthalmic Solution 0.75% | Percent of Subjects' Study Eyes Pupil Diameter Returning to Baseline | 30 minutes | 1 Participants |
| Phentolamine Ophthalmic Solution 0.75% | Percent of Subjects' Study Eyes Pupil Diameter Returning to Baseline | 60 minutes | 26 Participants |
| Phentolamine Ophthalmic Solution 0.75% | Percent of Subjects' Study Eyes Pupil Diameter Returning to Baseline | 90 minutes | 46 Participants |
| Phentolamine Ophthalmic Solution 0.75% | Percent of Subjects' Study Eyes Pupil Diameter Returning to Baseline | 2 hours | 55 Participants |
| Phentolamine Ophthalmic Solution 0.75% | Percent of Subjects' Study Eyes Pupil Diameter Returning to Baseline | 3 hours | 75 Participants |
| Phentolamine Ophthalmic Solution 0.75% | Percent of Subjects' Study Eyes Pupil Diameter Returning to Baseline | 4 hours | 77 Participants |
| Phentolamine Ophthalmic Solution 0.75% | Percent of Subjects' Study Eyes Pupil Diameter Returning to Baseline | 6 Hours | 85 Participants |
| Phentolamine Ophthalmic Solution 0.75% | Percent of Subjects' Study Eyes Pupil Diameter Returning to Baseline | 24 Hours | 86 Participants |
| Phentolamine Ophthalmic Solution Vehicle | Percent of Subjects' Study Eyes Pupil Diameter Returning to Baseline | 24 Hours | 60 Participants |
| Phentolamine Ophthalmic Solution Vehicle | Percent of Subjects' Study Eyes Pupil Diameter Returning to Baseline | 30 minutes | 3 Participants |
| Phentolamine Ophthalmic Solution Vehicle | Percent of Subjects' Study Eyes Pupil Diameter Returning to Baseline | 3 hours | 16 Participants |
| Phentolamine Ophthalmic Solution Vehicle | Percent of Subjects' Study Eyes Pupil Diameter Returning to Baseline | 60 minutes | 2 Participants |
| Phentolamine Ophthalmic Solution Vehicle | Percent of Subjects' Study Eyes Pupil Diameter Returning to Baseline | 6 Hours | 41 Participants |
| Phentolamine Ophthalmic Solution Vehicle | Percent of Subjects' Study Eyes Pupil Diameter Returning to Baseline | 90 minutes | 6 Participants |
| Phentolamine Ophthalmic Solution Vehicle | Percent of Subjects' Study Eyes Pupil Diameter Returning to Baseline | 4 hours | 27 Participants |
| Phentolamine Ophthalmic Solution Vehicle | Percent of Subjects' Study Eyes Pupil Diameter Returning to Baseline | 2 hours | 10 Participants |
Secondary
Percent of Subjects With Unchanged Accommodation From Baseline
Percentage of subjects with unchanged accommodation from baseline (-1 hour)
Time frame: up to 6 hours
Population: Subjects within each overall treatment group were randomized to receive one of 3 mydriatic agents (3;1;1); therefore the number of subjects in the the subgroups do not match the overall number analyzed.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Phentolamine Ophthalmic Solution 0.75% | Percent of Subjects With Unchanged Accommodation From Baseline | Tropicamide, 0 Minutes | Unchanged from Baseline | 2 Participants |
| Phentolamine Ophthalmic Solution 0.75% | Percent of Subjects With Unchanged Accommodation From Baseline | Phenylephrine, 0 minutes | Changed from Baseline | 26 Participants |
| Phentolamine Ophthalmic Solution 0.75% | Percent of Subjects With Unchanged Accommodation From Baseline | Phenylephrine, 60 minutes | Unchanged from Baseline | 29 Participants |
| Phentolamine Ophthalmic Solution 0.75% | Percent of Subjects With Unchanged Accommodation From Baseline | Phenylephrine, 60 minutes | Changed from Baseline | 27 Participants |
| Phentolamine Ophthalmic Solution 0.75% | Percent of Subjects With Unchanged Accommodation From Baseline | Phenylephrine, 90 minutes | Unchanged from Baseline | 38 Participants |
| Phentolamine Ophthalmic Solution 0.75% | Percent of Subjects With Unchanged Accommodation From Baseline | Phenylephrine, 90 minutes | Changed from Baseline | 18 Participants |
| Phentolamine Ophthalmic Solution 0.75% | Percent of Subjects With Unchanged Accommodation From Baseline | Phenylephrine, 2 hours | Unchanged from Baseline | 40 Participants |
| Phentolamine Ophthalmic Solution 0.75% | Percent of Subjects With Unchanged Accommodation From Baseline | Phenylephrine, 2 hours | Changed from Baseline | 16 Participants |
| Phentolamine Ophthalmic Solution 0.75% | Percent of Subjects With Unchanged Accommodation From Baseline | Phenylephrine, 3 hours | Unchanged from Baseline | 38 Participants |
| Phentolamine Ophthalmic Solution 0.75% | Percent of Subjects With Unchanged Accommodation From Baseline | Phenylephrine, 3 hours | Changed from Baseline | 18 Participants |
| Phentolamine Ophthalmic Solution 0.75% | Percent of Subjects With Unchanged Accommodation From Baseline | Phenylephrine, 4 hours | Unchanged from Baseline | 39 Participants |
| Phentolamine Ophthalmic Solution 0.75% | Percent of Subjects With Unchanged Accommodation From Baseline | Phenylephrine, 4 hours | Changed from Baseline | 17 Participants |
| Phentolamine Ophthalmic Solution 0.75% | Percent of Subjects With Unchanged Accommodation From Baseline | Phenylephrine, 6 hours | Unchanged from Baseline | 43 Participants |
| Phentolamine Ophthalmic Solution 0.75% | Percent of Subjects With Unchanged Accommodation From Baseline | Phenylephrine, 6 hours | Changed from Baseline | 13 Participants |
| Phentolamine Ophthalmic Solution 0.75% | Percent of Subjects With Unchanged Accommodation From Baseline | Phenylephrine, 0 minutes | Unchanged from Baseline | 30 Participants |
| Phentolamine Ophthalmic Solution 0.75% | Percent of Subjects With Unchanged Accommodation From Baseline | Tropicamide, 0 Minutes | Changed from Baseline | 17 Participants |
| Phentolamine Ophthalmic Solution 0.75% | Percent of Subjects With Unchanged Accommodation From Baseline | Tropicamide, 60 Minutes | Unchanged from Baseline | 6 Participants |
| Phentolamine Ophthalmic Solution 0.75% | Percent of Subjects With Unchanged Accommodation From Baseline | Tropicamide, 60 Minutes | Changed from Baseline | 13 Participants |
| Phentolamine Ophthalmic Solution 0.75% | Percent of Subjects With Unchanged Accommodation From Baseline | Tropicamide, 90 Minutes | Unchanged from Baseline | 10 Participants |
| Phentolamine Ophthalmic Solution 0.75% | Percent of Subjects With Unchanged Accommodation From Baseline | Tropicamide, 90 Minutes | Changed from Baseline | 9 Participants |
| Phentolamine Ophthalmic Solution 0.75% | Percent of Subjects With Unchanged Accommodation From Baseline | Tropicamide, 2 Hours | Unchanged from Baseline | 12 Participants |
| Phentolamine Ophthalmic Solution 0.75% | Percent of Subjects With Unchanged Accommodation From Baseline | Tropicamide, 2 Hours | Changed from Baseline | 7 Participants |
| Phentolamine Ophthalmic Solution 0.75% | Percent of Subjects With Unchanged Accommodation From Baseline | Tropicamide, 3 Hours | Unchanged from Baseline | 13 Participants |
| Phentolamine Ophthalmic Solution 0.75% | Percent of Subjects With Unchanged Accommodation From Baseline | Tropicamide, 3 Hours | Changed from Baseline | 6 Participants |
| Phentolamine Ophthalmic Solution 0.75% | Percent of Subjects With Unchanged Accommodation From Baseline | Tropicamide, 4 Hours | Unchanged from Baseline | 14 Participants |
| Phentolamine Ophthalmic Solution 0.75% | Percent of Subjects With Unchanged Accommodation From Baseline | Tropicamide, 4 Hours | Changed from Baseline | 5 Participants |
| Phentolamine Ophthalmic Solution 0.75% | Percent of Subjects With Unchanged Accommodation From Baseline | Tropicamide, 6 Hours | Unchanged from Baseline | 14 Participants |
| Phentolamine Ophthalmic Solution 0.75% | Percent of Subjects With Unchanged Accommodation From Baseline | Tropicamide, 6 Hours | Changed from Baseline | 5 Participants |
| Phentolamine Ophthalmic Solution 0.75% | Percent of Subjects With Unchanged Accommodation From Baseline | Paremyd, 0 Minutes | Unchanged from Baseline | 2 Participants |
| Phentolamine Ophthalmic Solution 0.75% | Percent of Subjects With Unchanged Accommodation From Baseline | Paremyd, 0 Minutes | Changed from Baseline | 17 Participants |
| Phentolamine Ophthalmic Solution 0.75% | Percent of Subjects With Unchanged Accommodation From Baseline | Paremyd, 60 Minutes | Unchanged from Baseline | 6 Participants |
| Phentolamine Ophthalmic Solution 0.75% | Percent of Subjects With Unchanged Accommodation From Baseline | Paremyd, 60 Minutes | Changed from Baseline | 13 Participants |
| Phentolamine Ophthalmic Solution 0.75% | Percent of Subjects With Unchanged Accommodation From Baseline | Paremyd, 90 Minutes | Unchanged from Baseline | 7 Participants |
| Phentolamine Ophthalmic Solution 0.75% | Percent of Subjects With Unchanged Accommodation From Baseline | Paremyd, 90 Minutes | Changed from Baseline | 12 Participants |
| Phentolamine Ophthalmic Solution 0.75% | Percent of Subjects With Unchanged Accommodation From Baseline | Paremyd, 2 Hours | Unchanged from Baseline | 9 Participants |
| Phentolamine Ophthalmic Solution 0.75% | Percent of Subjects With Unchanged Accommodation From Baseline | Paremyd, 2 Hours | Changed from Baseline | 10 Participants |
| Phentolamine Ophthalmic Solution 0.75% | Percent of Subjects With Unchanged Accommodation From Baseline | Paremyd, 3 Hours | Unchanged from Baseline | 11 Participants |
| Phentolamine Ophthalmic Solution 0.75% | Percent of Subjects With Unchanged Accommodation From Baseline | Paremyd, 3 Hours | Changed from Baseline | 8 Participants |
| Phentolamine Ophthalmic Solution 0.75% | Percent of Subjects With Unchanged Accommodation From Baseline | Paremyd, 4 Hours | Unchanged from Baseline | 14 Participants |
| Phentolamine Ophthalmic Solution 0.75% | Percent of Subjects With Unchanged Accommodation From Baseline | Paremyd, 4 Hours | Changed from Baseline | 5 Participants |
| Phentolamine Ophthalmic Solution 0.75% | Percent of Subjects With Unchanged Accommodation From Baseline | Paremyd, 6 Hours | Unchanged from Baseline | 14 Participants |
| Phentolamine Ophthalmic Solution 0.75% | Percent of Subjects With Unchanged Accommodation From Baseline | Paremyd, 6 Hours | Changed from Baseline | 5 Participants |
| Phentolamine Ophthalmic Solution 0.75% | Percent of Subjects With Unchanged Accommodation From Baseline | Tropicamide or Paremyd, 0 Minutes | Unchanged from Baseline | 4 Participants |
| Phentolamine Ophthalmic Solution 0.75% | Percent of Subjects With Unchanged Accommodation From Baseline | Tropicamide or Paremyd, 0 Minutes | Changed from Baseline | 34 Participants |
| Phentolamine Ophthalmic Solution 0.75% | Percent of Subjects With Unchanged Accommodation From Baseline | Tropicamide or Paremyd, 60 Minutes | Unchanged from Baseline | 12 Participants |
| Phentolamine Ophthalmic Solution 0.75% | Percent of Subjects With Unchanged Accommodation From Baseline | Tropicamide or Paremyd, 60 Minutes | Changed from Baseline | 26 Participants |
| Phentolamine Ophthalmic Solution 0.75% | Percent of Subjects With Unchanged Accommodation From Baseline | Tropicamide or Paremyd, 90 Minutes | Unchanged from Baseline | 17 Participants |
| Phentolamine Ophthalmic Solution 0.75% | Percent of Subjects With Unchanged Accommodation From Baseline | Tropicamide or Paremyd, 90 Minutes | Changed from Baseline | 21 Participants |
| Phentolamine Ophthalmic Solution 0.75% | Percent of Subjects With Unchanged Accommodation From Baseline | Tropicamide or Paremyd, 2 Hours | Unchanged from Baseline | 21 Participants |
| Phentolamine Ophthalmic Solution 0.75% | Percent of Subjects With Unchanged Accommodation From Baseline | Tropicamide or Paremyd, 2 Hours | Changed from Baseline | 17 Participants |
| Phentolamine Ophthalmic Solution 0.75% | Percent of Subjects With Unchanged Accommodation From Baseline | Tropicamide or Paremyd, 3 Hours | Unchanged from Baseline | 24 Participants |
| Phentolamine Ophthalmic Solution 0.75% | Percent of Subjects With Unchanged Accommodation From Baseline | Tropicamide or Paremyd, 3 Hours | Changed from Baseline | 14 Participants |
| Phentolamine Ophthalmic Solution 0.75% | Percent of Subjects With Unchanged Accommodation From Baseline | Tropicamide or Paremyd, 4 Hours | Unchanged from Baseline | 28 Participants |
| Phentolamine Ophthalmic Solution 0.75% | Percent of Subjects With Unchanged Accommodation From Baseline | Tropicamide or Paremyd, 4 Hours | Changed from Baseline | 10 Participants |
| Phentolamine Ophthalmic Solution 0.75% | Percent of Subjects With Unchanged Accommodation From Baseline | Tropicamide or Paremyd, 6 Hours | Unchanged from Baseline | 28 Participants |
| Phentolamine Ophthalmic Solution 0.75% | Percent of Subjects With Unchanged Accommodation From Baseline | Tropicamide or Paremyd, 6 Hours | Changed from Baseline | 10 Participants |
| Phentolamine Ophthalmic Solution Vehicle | Percent of Subjects With Unchanged Accommodation From Baseline | Tropicamide or Paremyd, 4 Hours | Unchanged from Baseline | 21 Participants |
| Phentolamine Ophthalmic Solution Vehicle | Percent of Subjects With Unchanged Accommodation From Baseline | Phenylephrine, 0 minutes | Unchanged from Baseline | 37 Participants |
| Phentolamine Ophthalmic Solution Vehicle | Percent of Subjects With Unchanged Accommodation From Baseline | Paremyd, 0 Minutes | Unchanged from Baseline | 3 Participants |
| Phentolamine Ophthalmic Solution Vehicle | Percent of Subjects With Unchanged Accommodation From Baseline | Phenylephrine, 0 minutes | Changed from Baseline | 18 Participants |
| Phentolamine Ophthalmic Solution Vehicle | Percent of Subjects With Unchanged Accommodation From Baseline | Tropicamide or Paremyd, 0 Minutes | Unchanged from Baseline | 5 Participants |
| Phentolamine Ophthalmic Solution Vehicle | Percent of Subjects With Unchanged Accommodation From Baseline | Phenylephrine, 60 minutes | Unchanged from Baseline | 39 Participants |
| Phentolamine Ophthalmic Solution Vehicle | Percent of Subjects With Unchanged Accommodation From Baseline | Paremyd, 0 Minutes | Changed from Baseline | 15 Participants |
| Phentolamine Ophthalmic Solution Vehicle | Percent of Subjects With Unchanged Accommodation From Baseline | Phenylephrine, 60 minutes | Changed from Baseline | 16 Participants |
| Phentolamine Ophthalmic Solution Vehicle | Percent of Subjects With Unchanged Accommodation From Baseline | Tropicamide or Paremyd, 2 Hours | Changed from Baseline | 23 Participants |
| Phentolamine Ophthalmic Solution Vehicle | Percent of Subjects With Unchanged Accommodation From Baseline | Phenylephrine, 90 minutes | Unchanged from Baseline | 40 Participants |
| Phentolamine Ophthalmic Solution Vehicle | Percent of Subjects With Unchanged Accommodation From Baseline | Paremyd, 60 Minutes | Unchanged from Baseline | 6 Participants |
| Phentolamine Ophthalmic Solution Vehicle | Percent of Subjects With Unchanged Accommodation From Baseline | Phenylephrine, 90 minutes | Changed from Baseline | 15 Participants |
| Phentolamine Ophthalmic Solution Vehicle | Percent of Subjects With Unchanged Accommodation From Baseline | Tropicamide or Paremyd, 0 Minutes | Changed from Baseline | 31 Participants |
| Phentolamine Ophthalmic Solution Vehicle | Percent of Subjects With Unchanged Accommodation From Baseline | Phenylephrine, 2 hours | Unchanged from Baseline | 42 Participants |
| Phentolamine Ophthalmic Solution Vehicle | Percent of Subjects With Unchanged Accommodation From Baseline | Paremyd, 60 Minutes | Changed from Baseline | 12 Participants |
| Phentolamine Ophthalmic Solution Vehicle | Percent of Subjects With Unchanged Accommodation From Baseline | Phenylephrine, 2 hours | Changed from Baseline | 13 Participants |
| Phentolamine Ophthalmic Solution Vehicle | Percent of Subjects With Unchanged Accommodation From Baseline | Tropicamide or Paremyd, 6 Hours | Unchanged from Baseline | 23 Participants |
| Phentolamine Ophthalmic Solution Vehicle | Percent of Subjects With Unchanged Accommodation From Baseline | Phenylephrine, 3 hours | Unchanged from Baseline | 45 Participants |
| Phentolamine Ophthalmic Solution Vehicle | Percent of Subjects With Unchanged Accommodation From Baseline | Paremyd, 90 Minutes | Unchanged from Baseline | 7 Participants |
| Phentolamine Ophthalmic Solution Vehicle | Percent of Subjects With Unchanged Accommodation From Baseline | Phenylephrine, 3 hours | Changed from Baseline | 10 Participants |
| Phentolamine Ophthalmic Solution Vehicle | Percent of Subjects With Unchanged Accommodation From Baseline | Tropicamide or Paremyd, 60 Minutes | Unchanged from Baseline | 11 Participants |
| Phentolamine Ophthalmic Solution Vehicle | Percent of Subjects With Unchanged Accommodation From Baseline | Phenylephrine, 4 hours | Unchanged from Baseline | 42 Participants |
| Phentolamine Ophthalmic Solution Vehicle | Percent of Subjects With Unchanged Accommodation From Baseline | Paremyd, 90 Minutes | Changed from Baseline | 11 Participants |
| Phentolamine Ophthalmic Solution Vehicle | Percent of Subjects With Unchanged Accommodation From Baseline | Phenylephrine, 4 hours | Changed from Baseline | 13 Participants |
| Phentolamine Ophthalmic Solution Vehicle | Percent of Subjects With Unchanged Accommodation From Baseline | Tropicamide or Paremyd, 3 Hours | Unchanged from Baseline | 18 Participants |
| Phentolamine Ophthalmic Solution Vehicle | Percent of Subjects With Unchanged Accommodation From Baseline | Phenylephrine, 6 hours | Unchanged from Baseline | 48 Participants |
| Phentolamine Ophthalmic Solution Vehicle | Percent of Subjects With Unchanged Accommodation From Baseline | Paremyd, 2 Hours | Unchanged from Baseline | 7 Participants |
| Phentolamine Ophthalmic Solution Vehicle | Percent of Subjects With Unchanged Accommodation From Baseline | Phenylephrine, 6 hours | Changed from Baseline | 7 Participants |
| Phentolamine Ophthalmic Solution Vehicle | Percent of Subjects With Unchanged Accommodation From Baseline | Tropicamide or Paremyd, 60 Minutes | Changed from Baseline | 25 Participants |
| Phentolamine Ophthalmic Solution Vehicle | Percent of Subjects With Unchanged Accommodation From Baseline | Tropicamide, 0 Minutes | Unchanged from Baseline | 2 Participants |
| Phentolamine Ophthalmic Solution Vehicle | Percent of Subjects With Unchanged Accommodation From Baseline | Paremyd, 2 Hours | Changed from Baseline | 11 Participants |
| Phentolamine Ophthalmic Solution Vehicle | Percent of Subjects With Unchanged Accommodation From Baseline | Tropicamide, 0 Minutes | Changed from Baseline | 16 Participants |
| Phentolamine Ophthalmic Solution Vehicle | Percent of Subjects With Unchanged Accommodation From Baseline | Tropicamide or Paremyd, 4 Hours | Changed from Baseline | 15 Participants |
| Phentolamine Ophthalmic Solution Vehicle | Percent of Subjects With Unchanged Accommodation From Baseline | Tropicamide, 60 Minutes | Unchanged from Baseline | 5 Participants |
| Phentolamine Ophthalmic Solution Vehicle | Percent of Subjects With Unchanged Accommodation From Baseline | Paremyd, 3 Hours | Unchanged from Baseline | 10 Participants |
| Phentolamine Ophthalmic Solution Vehicle | Percent of Subjects With Unchanged Accommodation From Baseline | Tropicamide, 60 Minutes | Changed from Baseline | 13 Participants |
| Phentolamine Ophthalmic Solution Vehicle | Percent of Subjects With Unchanged Accommodation From Baseline | Tropicamide or Paremyd, 90 Minutes | Unchanged from Baseline | 12 Participants |
| Phentolamine Ophthalmic Solution Vehicle | Percent of Subjects With Unchanged Accommodation From Baseline | Tropicamide, 90 Minutes | Unchanged from Baseline | 5 Participants |
| Phentolamine Ophthalmic Solution Vehicle | Percent of Subjects With Unchanged Accommodation From Baseline | Paremyd, 3 Hours | Changed from Baseline | 8 Participants |
| Phentolamine Ophthalmic Solution Vehicle | Percent of Subjects With Unchanged Accommodation From Baseline | Tropicamide, 90 Minutes | Changed from Baseline | 13 Participants |
| Phentolamine Ophthalmic Solution Vehicle | Percent of Subjects With Unchanged Accommodation From Baseline | Tropicamide or Paremyd, 3 Hours | Changed from Baseline | 18 Participants |
| Phentolamine Ophthalmic Solution Vehicle | Percent of Subjects With Unchanged Accommodation From Baseline | Tropicamide, 2 Hours | Unchanged from Baseline | 6 Participants |
| Phentolamine Ophthalmic Solution Vehicle | Percent of Subjects With Unchanged Accommodation From Baseline | Paremyd, 4 Hours | Unchanged from Baseline | 11 Participants |
| Phentolamine Ophthalmic Solution Vehicle | Percent of Subjects With Unchanged Accommodation From Baseline | Tropicamide, 2 Hours | Changed from Baseline | 12 Participants |
| Phentolamine Ophthalmic Solution Vehicle | Percent of Subjects With Unchanged Accommodation From Baseline | Tropicamide or Paremyd, 90 Minutes | Changed from Baseline | 24 Participants |
| Phentolamine Ophthalmic Solution Vehicle | Percent of Subjects With Unchanged Accommodation From Baseline | Tropicamide, 3 Hours | Unchanged from Baseline | 8 Participants |
| Phentolamine Ophthalmic Solution Vehicle | Percent of Subjects With Unchanged Accommodation From Baseline | Paremyd, 4 Hours | Changed from Baseline | 7 Participants |
| Phentolamine Ophthalmic Solution Vehicle | Percent of Subjects With Unchanged Accommodation From Baseline | Tropicamide, 3 Hours | Changed from Baseline | 10 Participants |
| Phentolamine Ophthalmic Solution Vehicle | Percent of Subjects With Unchanged Accommodation From Baseline | Tropicamide or Paremyd, 6 Hours | Changed from Baseline | 13 Participants |
| Phentolamine Ophthalmic Solution Vehicle | Percent of Subjects With Unchanged Accommodation From Baseline | Tropicamide, 4 Hours | Unchanged from Baseline | 10 Participants |
| Phentolamine Ophthalmic Solution Vehicle | Percent of Subjects With Unchanged Accommodation From Baseline | Paremyd, 6 Hours | Unchanged from Baseline | 11 Participants |
| Phentolamine Ophthalmic Solution Vehicle | Percent of Subjects With Unchanged Accommodation From Baseline | Tropicamide, 4 Hours | Changed from Baseline | 8 Participants |
| Phentolamine Ophthalmic Solution Vehicle | Percent of Subjects With Unchanged Accommodation From Baseline | Tropicamide or Paremyd, 2 Hours | Unchanged from Baseline | 13 Participants |
| Phentolamine Ophthalmic Solution Vehicle | Percent of Subjects With Unchanged Accommodation From Baseline | Tropicamide, 6 Hours | Unchanged from Baseline | 12 Participants |
| Phentolamine Ophthalmic Solution Vehicle | Percent of Subjects With Unchanged Accommodation From Baseline | Paremyd, 6 Hours | Changed from Baseline | 7 Participants |
| Phentolamine Ophthalmic Solution Vehicle | Percent of Subjects With Unchanged Accommodation From Baseline | Tropicamide, 6 Hours | Changed from Baseline | 6 Participants |
Secondary
Pupil Diameter (Change From Max)
Change (mm) from maximum pharmacologically-induced mydriatic pupil diameter (0 minutes)
Time frame: up to 24 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phentolamine Ophthalmic Solution 0.75% | Pupil Diameter (Change From Max) | Baseline (-1 Hour) | 5.085 millimeters | Standard Deviation 0.9295 |
| Phentolamine Ophthalmic Solution 0.75% | Pupil Diameter (Change From Max) | 0 minutes | 7.207 millimeters | Standard Deviation 1.024 |
| Phentolamine Ophthalmic Solution 0.75% | Pupil Diameter (Change From Max) | 30 minutes | 0.025 millimeters | Standard Deviation 0.478 |
| Phentolamine Ophthalmic Solution 0.75% | Pupil Diameter (Change From Max) | 60 minutes | -1.308 millimeters | Standard Deviation 0.8705 |
| Phentolamine Ophthalmic Solution 0.75% | Pupil Diameter (Change From Max) | 90 minutes | -2.192 millimeters | Standard Deviation 1.0117 |
| Phentolamine Ophthalmic Solution 0.75% | Pupil Diameter (Change From Max) | 2 hours | -2.429 millimeters | Standard Deviation 0.9837 |
| Phentolamine Ophthalmic Solution 0.75% | Pupil Diameter (Change From Max) | 3 hours | -2.828 millimeters | Standard Deviation 0.9817 |
| Phentolamine Ophthalmic Solution 0.75% | Pupil Diameter (Change From Max) | 4 hours | -2.991 millimeters | Standard Deviation 1.0793 |
| Phentolamine Ophthalmic Solution 0.75% | Pupil Diameter (Change From Max) | 6 hours | -3.338 millimeters | Standard Deviation 1.0797 |
| Phentolamine Ophthalmic Solution 0.75% | Pupil Diameter (Change From Max) | 24 Hours | -3.375 millimeters | Standard Deviation 1.2302 |
| Phentolamine Ophthalmic Solution Vehicle | Pupil Diameter (Change From Max) | 4 hours | -1.159 millimeters | Standard Deviation 0.8223 |
| Phentolamine Ophthalmic Solution Vehicle | Pupil Diameter (Change From Max) | Baseline (-1 Hour) | 5.177 millimeters | Standard Deviation 0.9678 |
| Phentolamine Ophthalmic Solution Vehicle | Pupil Diameter (Change From Max) | 2 hours | -0.518 millimeters | Standard Deviation 0.593 |
| Phentolamine Ophthalmic Solution Vehicle | Pupil Diameter (Change From Max) | 0 minutes | 7.197 millimeters | Standard Deviation 1.1717 |
| Phentolamine Ophthalmic Solution Vehicle | Pupil Diameter (Change From Max) | 24 Hours | -2.173 millimeters | Standard Deviation 1.3868 |
| Phentolamine Ophthalmic Solution Vehicle | Pupil Diameter (Change From Max) | 30 minutes | 0.075 millimeters | Standard Deviation 0.4266 |
| Phentolamine Ophthalmic Solution Vehicle | Pupil Diameter (Change From Max) | 3 hours | -0.806 millimeters | Standard Deviation 0.6253 |
| Phentolamine Ophthalmic Solution Vehicle | Pupil Diameter (Change From Max) | 60 minutes | -0.122 millimeters | Standard Deviation 0.4055 |
| Phentolamine Ophthalmic Solution Vehicle | Pupil Diameter (Change From Max) | 6 hours | -1.634 millimeters | Standard Deviation 1.0595 |
| Phentolamine Ophthalmic Solution Vehicle | Pupil Diameter (Change From Max) | 90 minutes | -0.329 millimeters | Standard Deviation 0.4653 |