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KPI-012 for Corneal Ulcers (CHASE Trial)

Phase 2

Recruiting

Research Sponsored by Combangio, Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 56

Awards & highlights

CHASE Trial Summary

This trial will test if a new drug is safe and effective for people with a certain skin condition.

Who is the study for?

This trial is for individuals with PCED, a type of corneal ulcer, lasting at least 7 days due to conditions like diabetes-related eye disease or infections. Participants should not have had recent eye surgery, be using certain medications, or have severe eyelid issues. Pregnant or breastfeeding individuals are excluded.Check my eligibility

What is being tested?

The study aims to test the safety and effectiveness of KPI-012 ophthalmic solution compared to a placebo (vehicle) in treating PCED. It's designed to see if KPI-012 can help heal the cornea better than a non-active solution.See study design

What are the potential side effects?

While specific side effects aren't listed here, typical ones for ophthalmic solutions may include temporary discomfort in the eye, redness, blurred vision, tearing up more than usual or feeling like something is in your eye.

CHASE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 56

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 56

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 56 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Response status

CHASE Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Cohort 2, Arm 2Experimental Treatment1 Intervention

KPI-012 High Dose KPI-012 Ophthalmic Solution 3 U/mL 1 drop 4 times/day for 56 days

Group II: Cohort 2, Arm 1Experimental Treatment1 Intervention

KPI-012 Low Dose KPI-012 Ophthalmic Solution 1 U/mL 1 drop 4 times/day for 56 days

Group III: Cohort 1, Arm 1Experimental Treatment1 Intervention

KPI-012 High Dose KPI-012 Ophthalmic Solution 3 U/mL 1 drop 4 times/day for 56 days

Group IV: Cohort 2, Arm 3Placebo Group1 Intervention

KPI-012 Vehicle KPI-012 Ophthalmic Solution 0 U/mL 1 drop 4 times/day for 56 days

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Combangio, IncLead Sponsor

Kala Pharmaceuticals, Inc.Industry Sponsor

10 Previous Clinical Trials

4,073 Total Patients Enrolled

Kim Brazzell, PhDStudy DirectorKala Pharmaceuticals, Inc.

Media Library

KPI-012 Ophthalmic Solution (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05727878 — Phase 2

Corneal Ulcer Research Study Groups: Cohort 2, Arm 3, Cohort 2, Arm 1, Cohort 2, Arm 2, Cohort 1, Arm 1

Corneal Ulcer Clinical Trial 2023: KPI-012 Ophthalmic Solution Highlights & Side Effects. Trial Name: NCT05727878 — Phase 2

KPI-012 Ophthalmic Solution (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05727878 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the first cohort and arm of this experiment recognized by the FDA?

"Cohort 1, Arm 1 was awarded a safety score of 2 since it is in Phase 2; this suggests that the data collected thus far supports the drug's security but does not yet demonstrate effectiveness."

Answered by AI

How many healthcare facilities have been approved to participate in this experiment?

"As of right now, recruitment is underway at 5 medical sites. These locations are in Saint Louis, Chesterfield and Kansas City as well as 2 additional places. Prospective participants should opt for the nearest site to lessen any travel-related inconveniences associated with taking part in this trial."

Answered by AI

Are there any open slots in this investigation to enroll volunteers?

"Affirmative, the information hosted on clinicaltrials.gov indicates that this investigation is actively seeking participants. It was first published on February 1st 2023 and has since been updated to its present form as of 2/6/2023. The study requires two individuals from five distinct sites for enrollment."

Answered by AI

Approximately how many participants are involved in this clinical trial?

"Affirmative. Per the data located on clinicaltrials.gov, this medical trial is actively seeking participants. It was initially posted to the website in February of 2023 with recent updates occuring 6 days later. A total of 2 patients must be recruited from 5 individual sites for successful completion of the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Trial to Evaluate Safety and Efficacy of KPI-012 Ophthalmic Solution in Participants With PCED

2023. "Trial to Evaluate Safety and Efficacy of KPI-012 Ophthalmic Solution in Participants With PCED". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05727878.