Ocular Inflammation
Conditions
Brief summary
The purpose of this study is to evaluate the ocular safety, tolerability, and efficacy in topical administration of differing dosing regimens of ISV-303 compared to vehicle and Xibrom™ when dosed for 2 weeks in post-cataract-surgery volunteers.
Interventions
DRUGISV-303
0.075% of bromfenac in DuraSite dosed QD
DRUGDuraSite Vehicle
Vehicle dosed BID
DRUGXibrom™
0.09% bromfenac 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
* Scheduled for unilateral cataract surgery (phacoemulsification or extracapsular extraction) with posterior chamber intraocular lens implantation on the day prior to study enrollment * Meet the best corrected visual acuity score requirement * Meet the IOP requirement * Additional inclusion criteria also apply
Exclusion criteria
* Known hypersensitivity or poor tolerance to bromfenac sodium or any component of the study medications or any of the procedural medications * Use of any ocular topical, or systemic medication that could interfere with normal lacrimation, wound healing, the test agent, or the interpretation of study results, within 1 week prior to Day of Surgery * Additional
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: 0 is 0 cells; 1 is 1-10 cells; 2 is 11-20 cells; 3 is 21-50 cells; 4 is \> 50 cells. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ISV-303 BID ISV-303: 0.075% of Bromfenac in DuraSite Dosed BID | 40 |
| ISV-303 QD ISV-303: 0.075% of Bromfenac in DuraSite Dosed QD | 45 |
| Xibrom BID Xibrom™: Xibrom dosed BID | 42 |
| DuraSite Vehicle BID DuraSite Vehicle: Vehicle Dosed BID | 42 |
| Total | 169 |
Baseline characteristics
| Characteristic | ISV-303 BID | ISV-303 QD | Xibrom BID | DuraSite Vehicle BID | Total |
|---|---|---|---|---|---|
| Age, Continuous | 71.3 years STANDARD_DEVIATION 7.7 | 70.9 years STANDARD_DEVIATION 9.75 | 68.6 years STANDARD_DEVIATION 10.49 | 67.0 years STANDARD_DEVIATION 9.3 | 69.5 years STANDARD_DEVIATION 9.47 |
| Age, Customized 18-30 years | 0 participants | 0 participants | 1 participants | 0 participants | 1 participants |
| Age, Customized 31-50 years | 0 participants | 0 participants | 0 participants | 2 participants | 2 participants |
| Age, Customized 51-70 years | 22 participants | 22 participants | 22 participants | 25 participants | 91 participants |
| Age, Customized >70 years | 18 participants | 23 participants | 19 participants | 15 participants | 75 participants |
| Sex: Female, Male Female | 24 Participants | 21 Participants | 20 Participants | 24 Participants | 89 Participants |
| Sex: Female, Male Male | 16 Participants | 24 Participants | 22 Participants | 18 Participants | 80 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 40 | 4 / 45 | 1 / 42 | 1 / 42 |
| serious Total, serious adverse events | 1 / 40 | 0 / 45 | 1 / 42 | 0 / 42 |
Outcome results
Primary
Ocular Inflammation
Anterior Chamber Cell Grade 0 at Day 15 measured on a 0 to 4 scale: 0 is 0 cells; 1 is 1-10 cells; 2 is 11-20 cells; 3 is 21-50 cells; 4 is \> 50 cells.
Time frame: 15 days
Population: Intent-to-Treat (ITT) Population using Last Observation Carried Forward (LOCF) method.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ISV-303 BID | Ocular Inflammation | 21 participants |
| ISV-303 QD | Ocular Inflammation | 24 participants |
| Xibrom BID | Ocular Inflammation | 18 participants |
| DuraSite Vehicle BID | Ocular Inflammation | 8 participants |