Ocular Inflammation
Conditions
Brief summary
This study is designed to assess how KPI-121 1% compares to prednisolone acetate in reducing inflammation after cataract surgery in young children. Approximately half the participants will receive KPI-121 1% eye drops and the other half will receive prednisolone acetate.
Interventions
DRUGKPI-121 1%
eye drops
DRUGPrednisolone acetate
eye drops
Sponsors
Kala Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 3 Years
Healthy volunteers
No
Inclusion criteria
* Be a candidate for routine, uncomplicated cataract surgery
Exclusion criteria
* Have a post-traumatic cataract. * Have suspected permanent low vision or blindness in the fellow non-study eye. * Have active uveitis in either eye. * Have an ocular neoplasm in either eye. * Have the presence of viral, bacterial, or fungal disease in either eye. * Have glaucoma, ocular hypertension, steroid-induced IOP (intraocular pressure) rise or elevated IOP
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anterior Chamber Cell Grade | Day 15 | Anterior chamber cell grading is a way of quantifying the amount of inflammation in inflammatory eye processes. Higher values indicate greater inflammation. The anterior chamber cell grading uses whole numbers from 0 (no cells) to 4 (\> 30 cells) as follows: Anterior chamber cell grade 0 = no cells seen Anterior chamber cell grade 1 = 1 - 5 cells Anterior chamber cell grade 2 = 6 - 15 cells Anterior chamber cell grade 4 = greater than 30 cells |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modified Global Overall Assessment of Postoperative Inflammation | Day 15 | The Modified Global Overall Assessment is a way of quantifying the amount of post operative healing that has occurred. Lower values indicate greater healing.The Modified Global Assessment grading uses whole numbers from 0 (clear) to 2 (not improving or worsening) as follows: 0 = clear 1. = improving satisfactorily 2. = not improving or worsening |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| KPI-121 1% BID (Twice Daily) KPI-121 1%: eye drops | 1 |
| Prednisolone Acetate QID (Four Times Daily) Prednisolone acetate: eye drops | 1 |
| Total | 2 |
Baseline characteristics
| Characteristic | Prednisolone Acetate QID (Four Times Daily) | Total | KPI-121 1% BID (Twice Daily) |
|---|---|---|---|
| Age, Continuous | 6.0 months | 25.0 months | 44.0 months |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 2 Participants | 1 Participants |
| Region of Enrollment United States | 1 participants | 2 participants | 1 participants |
| Sex: Female, Male Female | 0 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 0 Participants |
| Study Eye OD (right eye) | 1 participants | 2 participants | 1 participants |
| Study Eye OS (left eye) | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 1 |
| other Total, other adverse events | 1 / 1 | 1 / 1 |
| serious Total, serious adverse events | 0 / 1 | 0 / 1 |
Outcome results
Primary
Anterior Chamber Cell Grade
Anterior chamber cell grading is a way of quantifying the amount of inflammation in inflammatory eye processes. Higher values indicate greater inflammation. The anterior chamber cell grading uses whole numbers from 0 (no cells) to 4 (\> 30 cells) as follows: Anterior chamber cell grade 0 = no cells seen Anterior chamber cell grade 1 = 1 - 5 cells Anterior chamber cell grade 2 = 6 - 15 cells Anterior chamber cell grade 4 = greater than 30 cells
Time frame: Day 15
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| KPI-121 1% BID | Anterior Chamber Cell Grade | Anterior chamber cell grade = 1 | 1 Participants |
| KPI-121 1% BID | Anterior Chamber Cell Grade | Anterior chamber cell grade = 3 | 0 Participants |
| KPI-121 1% BID | Anterior Chamber Cell Grade | Anterior chamber cell grade = 2 | 0 Participants |
| KPI-121 1% BID | Anterior Chamber Cell Grade | Anterior chamber cell grade = 4 | 0 Participants |
| KPI-121 1% BID | Anterior Chamber Cell Grade | Anterior chamber cell grade = 0 | 0 Participants |
| Prednisolone Acetate QID | Anterior Chamber Cell Grade | Anterior chamber cell grade = 4 | 0 Participants |
| Prednisolone Acetate QID | Anterior Chamber Cell Grade | Anterior chamber cell grade = 0 | 0 Participants |
| Prednisolone Acetate QID | Anterior Chamber Cell Grade | Anterior chamber cell grade = 1 | 1 Participants |
| Prednisolone Acetate QID | Anterior Chamber Cell Grade | Anterior chamber cell grade = 2 | 0 Participants |
| Prednisolone Acetate QID | Anterior Chamber Cell Grade | Anterior chamber cell grade = 3 | 0 Participants |
Secondary
Modified Global Overall Assessment of Postoperative Inflammation
The Modified Global Overall Assessment is a way of quantifying the amount of post operative healing that has occurred. Lower values indicate greater healing.The Modified Global Assessment grading uses whole numbers from 0 (clear) to 2 (not improving or worsening) as follows: 0 = clear 1. = improving satisfactorily 2. = not improving or worsening
Time frame: Day 15
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| KPI-121 1% BID | Modified Global Overall Assessment of Postoperative Inflammation | Modified Global Overall Assessment = 0 | 0 Participants |
| KPI-121 1% BID | Modified Global Overall Assessment of Postoperative Inflammation | Modified Global Overall Assessment = 1 | 1 Participants |
| KPI-121 1% BID | Modified Global Overall Assessment of Postoperative Inflammation | Modified Global Overall Assessment = 2 | 0 Participants |
| Prednisolone Acetate QID | Modified Global Overall Assessment of Postoperative Inflammation | Modified Global Overall Assessment = 0 | 0 Participants |
| Prednisolone Acetate QID | Modified Global Overall Assessment of Postoperative Inflammation | Modified Global Overall Assessment = 1 | 1 Participants |
| Prednisolone Acetate QID | Modified Global Overall Assessment of Postoperative Inflammation | Modified Global Overall Assessment = 2 | 0 Participants |