Ocular InflammationPhase 3NCT03596723

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

A Phase 3 study testing KPI-121 1% and Prednisolone acetate in people with Ocular Inflammation, run by Kala Pharmaceuticals, Inc. at 4 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages Up to 3 years
Conditions the study is for: Ocular Inflammation
What is being tested?: KPI-121 1% and Prednisolone acetate
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2 participants
Where: 4 sitesUnited States
Study dates: 3 Jul 2018to 18 Oct 2018
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Up to 3 years
All sexes
No healthy volunteers
Child

Who may be able to join

Be a candidate for routine, uncomplicated cataract surgery

Who cannot join

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

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Children's Eye Care, PC
Detroit, Michigan, 48201
Pediatric Ophthalmology of Erie, Inc.
Erie, Pennsylvania, 16501
Byers Eye Institute at Stanford University
Palo Alto, California, 94303
Houston Eye Associates
The Woodlands, Texas, 77380

Other trials in United States

About this study

Official title: Safety and Efficacy of KPI-121 1% Ophthalmic Suspension Versus Prednisolone Acetate Ophthalmic Suspension 1% for the Treatment of Inflammation Following Cataract Surgery in Children 0 to 3 Years of Age

Conditions: Ocular Inflammation
Being tested: KPI-121 1%, Prednisolone acetate

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

KPI-121 1%Drug
eye drops
Prednisolone acetateDrug
Also called Pred Forte
eye drops

Study groups in NCT03596723
Study group	Role	What they receive
KPI-121 1% BID (twice daily)	Experimental	Not described Receives: Drug: KPI-121 1%
Prednisolone acetate QID (four times daily)	Active comparator	Not described Receives: Drug: Prednisolone acetate

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Day 15

Secondary outcomes (1)

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
Measured: Day 15

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Jul 201818 Oct 2018

First posted24 Jul 2018
Study start3 Jul 2018
Primary completion28 Sep 2018
Study completion18 Oct 2018

Why it stopped: NDA #210565 did not trigger the need for a Pediatric Research Equity Act study.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Ocular InflammationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 2 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03596723
Sponsor's protocol ID: KPI-121-C-010
Status last verified: Sep 2020
First submitted: 12 Jul 2018
Last updated: 19 Oct 2020
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Efficacy of KPI-121 1% Ophthalmic Suspension Versus Prednisolone Acetate Ophthalmic Suspension 1% for the Treatment of Inflammation Following Cataract Surgery in Children 0 to 3 Years of Age
ClinicalTrials.gov ID: NCT03596723
Acronym / sponsor ID: KPI-121-C-010
Conditions: Ocular Inflammation
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: NDA #210565 did not trigger the need for a Pediatric Research Equity Act study.
Enrolment: 2 participants (actual)
Lead sponsor: Kala Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: 3 Jul 2018 (actual)
Primary completion: 28 Sep 2018 (actual)
Study completion: 18 Oct 2018 (actual)
First posted: 24 Jul 2018 (actual)
Results: Posted 7 Apr 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
KPI-121 1% BID (twice daily)	Experimental	Drug: KPI-121 1%
Prednisolone acetate QID (four times daily)	Active comparator	Drug: Prednisolone acetate

Who may qualify

Ages: Up to 3 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (1 listed)

Be a candidate for routine, uncomplicated cataract surgery

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
KPI-121 1%eye drops	Drug	KPI-121 1% BID (twice daily)
Prednisolone acetateAlso: Pred Forteeye drops	Drug	Prednisolone acetate QID (four times daily)

Primary outcome

Anterior Chamber Cell Grade
Time frame: 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

1 secondary outcome

Modified Global Overall Assessment of Postoperative Inflammation
Time frame: Day 15

Results and safety

Results posted to the registry on 7 Apr 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
KPI-121 1% BID (Twice Daily)	1	1
Prednisolone Acetate QID (Four Times Daily)	1	1

Primary outcome: Anterior Chamber Cell Grade

Time frame: Day 15. Count of participants. Unit: Participants

Measure	KPI-121 1% BID n = 1	Prednisolone Acetate QID n = 1
Anterior chamber cell grade = 0	0	0
Anterior chamber cell grade = 1	1	1
Anterior chamber cell grade = 2	0	0
Anterior chamber cell grade = 3	0	0
Anterior chamber cell grade = 4	0	0

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were collected from first dose of Investigational Product use at Visit 2 through conclusion of Visit 6, approximately 36 days.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
KPI-121 1% BID	0 of 1 (0%)	1 of 1 (100%)	0 of 1
Prednisolone Acetate QID	0 of 1 (0%)	1 of 1 (100%)	0 of 1

Limitations and caveats (from the sponsor): Due to stopping the study after just two subjects were enrolled, no meaningful conclusions could be reached.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing KPI-121 1% and Prednisolone acetate in people with Ocular Inflammation, run by Kala Pharmaceuticals, Inc. at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anterior Chamber Cell Grade (time frame: Day 15). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03596723.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.