Cataract
Conditions
Keywords
bromfenac concentrations, ISV-303, Bromday
Brief summary
The purpose of this study is to evaluate the aqueous humor concentration of bromfenac sodium in subjects administered multiple topical ocular doses of ISV-303 or Bromday™ QD prior to routine cataract surgery.
Interventions
DRUGISV-303
0.075% bromfenac in DuraSite dosed QD
DRUGBromday™
0.09% bromfenac dosed QD
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 (phacoemulsification or extracapsular extraction) with posterior chamber intraocular lens implantation * If a female is of childbearing potential, the subject must agree to and submit a urine sample for pregnancy testing at Visit 1 prior to enrollment and at the end of the study, and 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 and able to follow all instructions and attend all study visits * Able to self-administer study drug (or have a caregiver available to instill all doses of study drug)
Exclusion criteria
* Use of any drug containing bromfenac within 2 weeks prior to surgery * Contact lens wear during the dosing period * Known hypersensitivity or poor tolerance to bromfenac sodium or any component of the investigational medicinal product (IMP) or any of the procedural medications * Any serious complications with or macroscopic damage to the corneal epithelium * Currently pregnant, nursing, or planning a pregnancy; or be a woman that has a positive urine pregnancy test * Currently suffer from alcohol and/or drug abuse * Prior participation in this study protocol * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Aqueous Humor Bromfenac Concentration | Approximately 3 hours post last dose |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ISV-303 0.075% bromfenac in DuraSite vehicle dosed QD | 30 |
| Bromday 0.09% bromfenac dosed QD | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | ISV-303 | Bromday | Total |
|---|---|---|---|
| Age, Continuous | 70.6 years STANDARD_DEVIATION 10.14 | 68.2 years STANDARD_DEVIATION 9.5 | 69.4 years STANDARD_DEVIATION 9.8 |
| Age, Customized 18-30 years | 0 participants | 0 participants | 0 participants |
| Age, Customized 31-50 years | 1 participants | 0 participants | 1 participants |
| Age, Customized 51-70 years | 10 participants | 18 participants | 28 participants |
| Age, Customized >70 years | 19 participants | 12 participants | 31 participants |
| Sex: Female, Male Female | 12 Participants | 19 Participants | 31 Participants |
| Sex: Female, Male Male | 18 Participants | 11 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 30 | 0 / 29 |
| serious Total, serious adverse events | 0 / 30 | 0 / 29 |
Outcome results
Primary
Mean Aqueous Humor Bromfenac Concentration
Time frame: Approximately 3 hours post last dose
Population: Per-Protocol Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ISV-303 | Mean Aqueous Humor Bromfenac Concentration | 49.3 ng/mL | Standard Deviation 41.87 |
| Bromday | Mean Aqueous Humor Bromfenac Concentration | 23.7 ng/mL | Standard Deviation 16.31 |