Ocular Inflammation
Conditions
Brief summary
The purpose of this study is to evaluate the ocular safety, tolerability and efficacy of topical administration of ISV-303 compared with Durasite Vehicle.
Interventions
DRUGISV-303
0.075% bromfenac in DuraSite dosed BID
OTHERDuraSite Vehicle
DuraSite vehicle dosed BID
Sponsors
Sun Pharmaceutical Industries Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female subjects age 18 or older scheduled for unilateral cataract surgery with posterior chamber intraocular lens implantation * If a female is of childbearing potential, the subject must agree to and submit a negative pregnancy test before any protocol-specific procedures are conducted. The subject must use effective contraception for the duration of the study. Post menopausal is defined as having no menses for at least 12 consecutive months * Signature of the subject on the Informed Consent Form * Willing to avoid disallowed medications for the duration of the study * Willing and able to follow all instructions and attend all study visits * Able to self-administer the IMP (or have a caregiver available to instill all doses of study drugs ) * Additional inclusion criteria also apply
Exclusion criteria
* Known hypersensitivity or poor tolerance to bromfenac sodium or any component of the IMP or any of the procedural medications * Currently pregnant, nursing, or planning a pregnancy; or be a woman that has a positive pregnancy test * Currently suffer from alcohol and/or drug abuse * Prior (within 30 days of beginning study treatment) or anticipated concurrent use of an investigational drug or device * A condition or a situation, which in the investigator's opinion may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation * Additional inclusion criteria also apply
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Inflammation | 15 days | Anterior chamber cell grade 0 at Day 15 measured on a 0 to 4 scale where 0 is 0 cells; 1 is 1-10 cells; 2 is 11-20 cells; 3 is 21-50 cells; 4 is \> 50 cells, and no rescue medications. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ISV-303 0.075% bromfenac in DuraSite dosed BID | 168 |
| Vehicle DuraSite vehicle dosed BID | 85 |
| Total | 253 |
Baseline characteristics
| Characteristic | ISV-303 | Vehicle | Total |
|---|---|---|---|
| Age, Continuous | 69.6 years STANDARD_DEVIATION 8.9 | 72.0 years STANDARD_DEVIATION 9.07 | 70.4 years STANDARD_DEVIATION 9.01 |
| Age, Customized < 65 years | 44 participants | 16 participants | 60 participants |
| Age, Customized ≥ 65 years | 124 participants | 69 participants | 193 participants |
| Sex: Female, Male Female | 105 Participants | 48 Participants | 153 Participants |
| Sex: Female, Male Male | 63 Participants | 37 Participants | 100 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 17 / 170 | 5 / 85 |
| serious Total, serious adverse events | 1 / 170 | 1 / 85 |
Outcome results
Primary
Ocular Inflammation
Anterior chamber cell grade 0 at Day 15 measured on a 0 to 4 scale where 0 is 0 cells; 1 is 1-10 cells; 2 is 11-20 cells; 3 is 21-50 cells; 4 is \> 50 cells, and no rescue medications.
Time frame: 15 days
Population: Modified Intent-to-Treat (ITT) Population using Last Observation Carried Forward (LOCF) method.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ISV-303 | Ocular Inflammation | 64 participants |
| Vehicle | Ocular Inflammation | 19 participants |