Inflammation
Conditions
Brief summary
This is a multicenter, double-masked, randomized, vehicle-controlled, parallel-comparison study conducted at sites in the United States (US) in subjects undergoing routine unilateral cataract extraction and lens replacement (CELR) surgery via phacoemulsification
Detailed description
This is a phase 2, multicenter, double-masked, randomized, vehicle-controlled, parallel-comparison study conducted at sites in the US assessing the safety and ocular efficacy of VVN461 for treating post-operative ocular inflammation in subjects who undergo routine unilateral CELR surgery via phacoemulsification without surgical complication. Approximately 90 subjects (30 per group) will be randomized in a 1:1:1 ratio. Subjects will administer 1 eye drop in the study eye four times a day (QID) for 14 days.
Interventions
Topical ocular drug
Topical ocular drug
DRUGVehicle
Topical ocular drug
Sponsors
VivaVision Biotech, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double-masked drug product
Intervention model description
Double-masked, parallel, randomized
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥21 years of age and in good general health at Visit 1 (Screening) * Willing and able to provide informed consent and provide relevant privacy authorization(s) * Willing and able to comply with study requirements and visit schedule * Clear ocular media (other than cataract) in the study eye * Planning to undergo routine unilateral cataract surgery via phacoemulsification extraction and implantation of an intraocular lens.
Exclusion criteria
* Any ocular pain at Visit 1 (Screening) * Recent use of corticosteroids or oral non-steroidal anti-inflammatory drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anterior Chamber Cell (ACC): Categorical Cure | Day 14 | Proportion of subjects with grade of 0 using SUN Working Group Grading Scale (0 (none) to 4+ (\>50 cells in field). Note - higher values represent a WORSE outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of VVN461 | Day 21 | Number of subjects with Adverse Events |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| VVN461 1.0% VVN461 Ophthalmic Solution, 1.0%
VVN461 Ophthalmic Solution 1.0%: Topical ocular drug | 30 |
| VVN461 0.5% VVN461 Ophthalmic Solution, 0.5%
VVN461 Ophthalmic Solution 0.5%: Topical ocular drug | 30 |
| Vehicle VVN461 Vehicle
Vehicle: Topical ocular drug | 31 |
| Total | 91 |
Baseline characteristics
| Characteristic | VVN461 0.5% | Vehicle | Total | VVN461 1.0% |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 21 Participants | 24 Participants | 66 Participants | 21 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 7 Participants | 25 Participants | 9 Participants |
| Age, Continuous | 68.5 years STANDARD_DEVIATION 8.51 | 69.8 years STANDARD_DEVIATION 7.94 | 69.1 years STANDARD_DEVIATION 6.79 | 69.1 years STANDARD_DEVIATION 7.28 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 5 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 5 Participants | 12 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) White | 24 Participants | 22 Participants | 69 Participants | 23 Participants |
| Region of Enrollment United States | 30 participants | 31 participants | 91 participants | 30 participants |
| Sex: Female, Male Female | 23 Participants | 18 Participants | 55 Participants | 14 Participants |
| Sex: Female, Male Male | 7 Participants | 13 Participants | 36 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 | 0 / 31 |
| other Total, other adverse events | 0 / 30 | 0 / 30 | 0 / 31 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 | 0 / 31 |
Outcome results
Primary
Anterior Chamber Cell: Categorical Cure
Proportion of subjects with grade of 0 using SUN Working Group Grading Scale (0 (none) to 4+ (\>50 cells in field). Note - higher values represent a WORSE outcome.
Time frame: Day 14
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VVN461 1.0% | Anterior Chamber Cell: Categorical Cure | 18 Participants |
| VVN461 0.5% | Anterior Chamber Cell: Categorical Cure | 16 Participants |
| Vehicle | Anterior Chamber Cell: Categorical Cure | 6 Participants |
Secondary
Safety of VVN461
Number of subjects with Adverse Events
Time frame: Day 21
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VVN461 1.0% | Safety of VVN461 | 2 Participants |
| VVN461 0.5% | Safety of VVN461 | 3 Participants |
| Vehicle | Safety of VVN461 | 3 Participants |