Presbyopia
Conditions
Brief summary
Safety and Efficacy Study of BRIMOCHOL™ vs. BRIMOCHOL™ F vs. Carbachol Monotherapy Topical Ophthalmic Solutions in Subjects with Emmetropic Phakic and Pseudophakic Presbyopia
Detailed description
A 3-Dose, Multicenter, Randomized, Double-Masked, Crossover Phase 2 Safety and Efficacy Study of BRIMOCHOL™ Topical Ophthalmic Solution vs. BRIMOCHOL™ F Topical Ophthalmic Solution vs. Monotherapy with Carbachol Topical Ophthalmic Solution in Subjects with Emmetropic Phakic and Pseudophakic Presbyopia
Interventions
DRUGBRIMOCHOL™
A single drop in each eye at a visit.
DRUGBRIMOCHOL™ F
A single drop in each eye at a visit.
DRUGCarbachol
A single drop in each eye at a visit.
Sponsors
Visus Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female in good general health * Must have presbyopia
Exclusion criteria
* History of allergic reaction to the study drug or any of its components * Any disease or medical condition that, in the opinion of the Investigator, would prevent the subject from participating in the study or might confound study results
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects With a >=15 Letter Gain Without a < 5 Letter Loss in Near Visual Acuity | Day 1, Hour 1 post-dose | Primary Endpoint measured at Hour 1 post-dose at Study Visit - a Single drop Cohort |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline ETDRS Letters Score in Distance Visual Acuity | Day 1, Hour 1 post-dose | Secondary Endpoint measured at Hour 1 post-dose at Study Visit - a Single drop Cohort |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single Drop Cohort A single drop in each eye at a visit. | 18 |
| Total | 18 |
Baseline characteristics
| Characteristic | Single Drop Cohort |
|---|---|
| Age, Continuous | 52.3 Years STANDARD_DEVIATION 4.31 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 13 Participants |
| Region of Enrollment United States | 18 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 18 | 0 / 17 |
| other Total, other adverse events | 1 / 17 | 1 / 18 | 0 / 17 |
| serious Total, serious adverse events | 0 / 17 | 0 / 18 | 0 / 17 |
Outcome results
Primary
Proportion of Subjects With a >=15 Letter Gain Without a < 5 Letter Loss in Near Visual Acuity
Primary Endpoint measured at Hour 1 post-dose at Study Visit - a Single drop Cohort
Time frame: Day 1, Hour 1 post-dose
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BRIMOCHOL | Proportion of Subjects With a >=15 Letter Gain Without a < 5 Letter Loss in Near Visual Acuity | 15 Participants |
| BRIMOCHOL PF | Proportion of Subjects With a >=15 Letter Gain Without a < 5 Letter Loss in Near Visual Acuity | 15 Participants |
| Carbachol PF | Proportion of Subjects With a >=15 Letter Gain Without a < 5 Letter Loss in Near Visual Acuity | 16 Participants |
Secondary
Change From Baseline ETDRS Letters Score in Distance Visual Acuity
Secondary Endpoint measured at Hour 1 post-dose at Study Visit - a Single drop Cohort
Time frame: Day 1, Hour 1 post-dose
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BRIMOCHOL | Change From Baseline ETDRS Letters Score in Distance Visual Acuity | 2.4 ETDRS letters | Standard Deviation 3.39 |
| BRIMOCHOL PF | Change From Baseline ETDRS Letters Score in Distance Visual Acuity | 2.8 ETDRS letters | Standard Deviation 3.28 |
| Carbachol PF | Change From Baseline ETDRS Letters Score in Distance Visual Acuity | 3.1 ETDRS letters | Standard Deviation 2.86 |