Trial Outcomes & Findings for KPI-121 1% Versus Prednisolone for the Treatment of Inflammation Following Cataract Surgery in Children (NCT NCT03596723)

Last Updated: 2020-10-19

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

2 participants

Primary outcome timeframe

Day 15

Results posted on

2020-10-19

Participant Flow

Participant milestones

Participant milestones
Measure	KPI-121 1% BID (Twice Daily) Subjects randomized to KPI-121 1% eye drops	Prednisolone Acetate QID (Four Times Daily) Subjects randomized to Prednisolone acetate eye drops
Overall Study STARTED	1	1
Overall Study COMPLETED	1	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

KPI-121 1% Versus Prednisolone for the Treatment of Inflammation Following Cataract Surgery in Children

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Day 15

Outcome measures

Outcome measures
Measure	KPI-121 1% BID n=1 Participants KPI-121 1%: eye drops	Prednisolone Acetate QID n=1 Participants Prednisolone acetate: eye drops
Anterior Chamber Cell Grade Anterior chamber cell grade = 0	0 Participants	0 Participants
Anterior Chamber Cell Grade Anterior chamber cell grade = 1	1 Participants	1 Participants
Anterior Chamber Cell Grade Anterior chamber cell grade = 2	0 Participants	0 Participants
Anterior Chamber Cell Grade Anterior chamber cell grade = 3	0 Participants	0 Participants
Anterior Chamber Cell Grade Anterior chamber cell grade = 4	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	KPI-121 1% BID n=1 Participants KPI-121 1%: eye drops	Prednisolone Acetate QID n=1 Participants Prednisolone acetate: eye drops
Modified Global Overall Assessment of Postoperative Inflammation Modified Global Overall Assessment = 0	0 Participants	0 Participants
Modified Global Overall Assessment of Postoperative Inflammation Modified Global Overall Assessment = 1	1 Participants	1 Participants
Modified Global Overall Assessment of Postoperative Inflammation Modified Global Overall Assessment = 2	0 Participants	0 Participants

Adverse Events

KPI-121 1% BID

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Prednisolone Acetate QID

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	KPI-121 1% BID n=1 participants at risk KPI-121 1%: eye drops	Prednisolone Acetate QID n=1 participants at risk Prednisolone acetate: eye drops
Eye disorders Suture Related Complication	100.0% 1/1 • Number of events 1 • Adverse events were collected from first dose of Investigational Product use at Visit 2 through conclusion of Visit 6, approximately 36 days.	0.00% 0/1 • Adverse events were collected from first dose of Investigational Product use at Visit 2 through conclusion of Visit 6, approximately 36 days.
Eye disorders Increased Ocular Inflammation	100.0% 1/1 • Number of events 1 • Adverse events were collected from first dose of Investigational Product use at Visit 2 through conclusion of Visit 6, approximately 36 days.	0.00% 0/1 • Adverse events were collected from first dose of Investigational Product use at Visit 2 through conclusion of Visit 6, approximately 36 days.
Ear and labyrinth disorders Otitis Media	0.00% 0/1 • Adverse events were collected from first dose of Investigational Product use at Visit 2 through conclusion of Visit 6, approximately 36 days.	100.0% 1/1 • Number of events 1 • Adverse events were collected from first dose of Investigational Product use at Visit 2 through conclusion of Visit 6, approximately 36 days.

Additional Information

VP Clinical Development

Kala Pharmaceuticals, Inc

Phone: 781-996-5252

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	KPI-121 1% BID (Twice Daily) n=1 Participants KPI-121 1%: eye drops	Prednisolone Acetate QID (Four Times Daily) n=1 Participants Prednisolone acetate: eye drops	Total n=2 Participants Total of all reporting groups
Age, Continuous	44.0 months n=5 Participants	6.0 months n=7 Participants	25.0 months n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
Study Eye OD (right eye)	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
Study Eye OS (left eye)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants