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Ocular Infections, Irritations and InflammationsPhase 3Hawaii-1NCT02163824

Safety and Efficacy of KPI-121 in Subjects With Postsurgical Inflammation

A Phase 3 study testing KPI-121 0.25% and KPI-121 1.0% in people with Ocular Infections, Irritations and Inflammations, run by Kala Pharmaceuticals, Inc. at 23 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary purpose of this study is to determine the efficacy and safety of KPI-121 ophthalmic suspension compared to placebo in subjects who have undergone cataract surgery. The efficacy and safety of two different concentrations and two different dosing regimens of KPI-121 are also being assessed. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
KPI-121 0.25% and KPI-121 1.0%
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
380 participants
Where
23 sitesUnited States
Study dates
May 2014to Dec 2014
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Candidates for routine, uncomplicated cataract surgery
  • In Investigator's opinion, potential postoperative Snellen Distance VA by pinhole method of at least 20/200 in study eye.

Who cannot join

  • Known hypersensitivity/contraindication to study product(s) or components.
  • History of glaucoma, IOP >21 mmHg at the screening or randomization visits, or being treated for glaucoma in either eye.
  • Diagnosis of: ongoing ocular infection; severe/serious ocular condition that in judgment of Investigator could confound study assessments or limit compliance; severe/serious systemic disease or uncontrolled medical condition that in judgment of Investigator could confound study assessments or limit compliance; or have been exposed to an investigational drug within the 30 days prior to screening or 19 days following surgery.
  • In the opinion of Investigator or study coordinator, be unwilling or unable to comply with study protocol or unable to successfully instill eye drops.

Trial locations and contacts

23 sites in 1 country.

23 sites in 1 country

United States23 sites

  • Sall Research Medical Center

    Artesia, California, 90701

  • Cincinnati Eye Institute

    Cincinnati, Ohio, 45242

  • The Eye Center of Columbus

    Columbus, Ohio, 43215

  • Las Vegas Physicians Research Group

    Henderson, Nevada, 89052

  • Cornerstone Eye Care

    High Point, North Carolina, 27262

  • Price Vision Group

    Indianapolis, Indiana, 46260

  • Tauber Eye Center

    Kansas City, Missouri, 64111

  • The Eye Clinic of Texas, Affiliate of Houston Eye Associates

    League City, Texas, 77573

  • Taustine Eye Center

    Louisville, Kentucky, 40217

  • North Valley Eye Medical Group

    Mission Hills, California, 91345

  • Clayton Eye Center

    Morrow, Georgia, 30260

  • John-Kenyon American Eye Institute

    New Albany, Indiana, 47150

  • Raymond Fong, MDPC

    New York, New York, 10013

  • Virginia Eye Consultants

    Norfolk, Virginia, 23502

  • Martel Eye Medical Group

    Rancho Cordova, California, 95670

  • Rochester Ophthalmological Group, PC

    Rochester, New York, 14618

  • R&R Eye Research, LLC

    San Antonio, Texas, 78229

  • Kozlovsky Delay & Winter Eye Consultants, LLC

    San Antonio, Texas, 78230

  • Westside Research, LLC

    Spartanburg, South Carolina, 29306

  • Tekwani Vision Center

    St Louis, Missouri, 63128

  • Ophthalmology Associates

    St Louis, Missouri, 63131

  • Ophthalmology Consultants

    St Louis, Missouri, 63131

  • Wolstan & Goldberg Eye Associates

    Torrance, California, 90505

Other trials in United States

About this study

Official title: A Phase III, Double-Masked, Randomized, Controlled Trial of KPI-121 in Postsurgical Inflammation

The primary purpose of this study is to determine the efficacy and safety of KPI-121 ophthalmic suspension compared to placebo in subjects who have undergone cataract surgery. The efficacy and safety of two different concentrations and two different dosing regimens of KPI-121 are also being assessed.

Read the detailed description

This is a Phase III, multicenter, double-masked, randomized, placebo-controlled, parallel-group study designed to evaluate the efficacy and safety of two doses and two dosing regimens of KPI-121 ophthalmic suspension versus placebo in subjects who require treatment of postoperative anterior ocular inflammation.

Approximately 500 subjects will be screened and up to 402 subjects with one study eye each will be randomized in this study at approximately 25 centers located in the United States. Subjects who experience postoperative inflammation on the first day following routine, uncomplicated, cataract surgery and who meet all other eligibility criteria will be randomized to one of four study groups (0.25% four times daily or 1.0% two times daily) or Placebo A four times daily or Placebo B two times daily. Drug product or placebo will be initiated on the day following surgery and instilled as one to two drops in the study eye according to the assigned dosing regimen for 14 days.

This study will include up to 7 clinic visits (including the surgery day) over 18 to 33 days total study duration. Visit 1 (Screening) will occur between 14 to 1 day(s) prior to surgery, and subjects who meet preoperative screening inclusion/exclusion criteria will be entered into the study. At Visit 2 (Surgery/Day 0) subjects will undergo routine cataract surgery according to the Investigator's normal procedures. Visit 3 (Randomization/Day 1) will occur on the day following surgery.

Following randomization, subjects will be instructed to return to the clinic to be evaluated at Visit 4 (Day 3 +2 day), Visit 5 (Day 8 ±1 day), and Visit 6 (Day 15 ±1 day). The last dose of study product will be administered upon completion of 14 days of evaluation. Following the End of Study Product Use Visit (Visit 6; Day 15 ±1 day), subjects will be asked to return to the clinic on Day 17-19 for Visit 7 (Follow-Up) and will be released from the study.

Being tested
KPI-121 0.25%, KPI-121 1.0%, Vehicle of KPI-121 0.25%, Vehicle of KPI-121 1.0%
Keywords
postsurgical, postoperative, ocular, cataract, inflammation, pain, corticosteroid
Medical subject headings
Eye Infections, Inflammation, Cataract, Pain

What participants receive

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

  • KPI-121 0.25%Drug

    Also called KPI-121 0.25% Ophthalmic Suspension, Loteprednol etabonate 0.25%

    KPI-121 drug product will be supplied as 0.25% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.

  • KPI-121 1.0%Drug

    Also called KPI-121 1.0% Ophthalmic Suspension, Loteprednol etabonate 1.0%

    KPI-121 drug product will be supplied as 1.0% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.

  • Vehicle of KPI-121 0.25%Drug

    Also called Vehicle of KPI-121 0.25% Ophthalmic Suspension

    Placebo control arms will receive the same bottles containing vehicle of KPI-121 including all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate.

  • Vehicle of KPI-121 1.0%Drug

    Also called Vehicle of KPI-121 1.0% Ophthalmic Suspension

    Placebo control arms will receive the same bottles containing vehicle of KPI-121 including all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate.

Study groups in NCT02163824
Study groupRoleWhat they receive
KPI-121 0.25% QIDActive comparatorKPI-121 0.25% Ophthalmic Suspension dosed 4 times daily for 14 days after routine, uncomplicated surgery for cataract removal and intraocular lens implant.
Receives: Drug: KPI-121 0.25%
KPI-121 1.0% BIDActive comparatorKPI-121 1.0% Ophthalmic Suspension dosed 2 times daily for 14 days after routine, uncomplicated surgery for cataract removal and intraocular lens implant.
Receives: Drug: KPI-121 1.0%
Vehicle of KPI-121 0.25%Placebo comparatorVehicle of KPI-121 0.25% Ophthalmic Suspension dosed 4 times daily for 14 days after routine, uncomplicated surgery for cataract removal and intraocular lens implant.
Receives: Drug: Vehicle of KPI-121 0.25%
Vehicle of KPI-121 1.0%Placebo comparatorVehicle of KPI-121 1.0% Ophthalmic Suspension dosed 2 times daily for 14 days after routine, uncomplicated surgery for cataract removal and intraocular lens implant.
Receives: Drug: Vehicle of KPI-121 1.0%

What is being measured

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

  1. Resolution of Anterior Chamber Cells

    Subjects with complete resolution of anterior chamber cells (cell score = 0) without rescue medication at Day 8/Visit 5 and Day 15/Visit 6.

    0= No cells seen

    1. 1 to 5 cells
    2. 6 to 15 cells
    3. 16 to 30 cells
    4. greater than 30 cells

    Measured: Visit 5 (postoperative day 8) and Visit 6 (postoperative day 15)

  2. Resolution of Ocular Pain

    Subjects with complete resolution of pain (grade = 0) without rescue medication at Day 8/Visit 5 and Day 15/Visit 6.

    Measured: Visit 5 (postoperative day 8) and Visit 6 (postoperative day 15)

Secondary outcomes (4)

  1. Anterior Chamber Cell Grade at Visit 5.

    Mean Grade of Anterior Chamber Cells (Scale 0-4) at Visit 5/Day 8. The difference in mean grade of AC cell count grade at Day 8 for KPI-121 1% dosed twice daily (BID) or 0.25% dosed four times daily (QID) compared with vehicle (either dosed BID or QID). Investigators were asked to grade AC cell based on the following scale wherein higher scores indicate a higher degree of cells present and a decrease across time indicates the condition is getting better.

    Anterior Chamber Cells 0 = No cells seen

    1. 1 - 5 cells
    2. 6 - 15 cells
    3. 16 - 30 cells 4 = greater than 30 cells

    Measured: Visit 5 (postoperative day 8)

  2. Anterior Chamber Cell Grade at Visit 6.

    Mean Grade of Anterior Chamber Cells (Scale 0-4) at Visit 6/Day 15. The difference in mean grade of AC cell count grade at Day 15 for KPI-121 1% dosed twice daily (BID) or 0.25% dosed four times daily (QID) compared with vehicle (either dosed BID or QID). Investigators were asked to grade AC cell based on the following scale wherein higher scores indicate a higher degree of cells present and a decrease across time indicates the condition is getting better.

    Anterior Chamber Cells 0 = No cells seen

    1. 1 - 5 cells
    2. 6 - 15 cells
    3. 16 - 30 cells 4 = greater than 30 cells

    Measured: Visit 6 (postoperative day 15)

  3. Ocular Pain Grades at Day 8.

    Mean Grade of Ocular Pain (Scale 0-5) at Visit 5/Day 8. The difference in mean grade of ocular pain grade at Day 8 for KPI-121 1% dosed twice daily (BID) or 0.25% dosed four times daily (QID) compared with vehicle (either dosed BID or QID). Subjects were given the Subject-Rated Ocular Pain Assessment to subjectively rate their pain. Higher scores were worse outcomes.

    The following scoring scale was used for ocular pain:

    0 = None

    1. Minimal
    2. Mild
    3. Moderate
    4. Moderately Severe
    5. Severe

    Measured: Visit 5 (postoperative day 8)

  4. Ocular Pain Grades at Day 15.

    Mean Grade of Ocular Pain (Scale 0-5) at Visit 6/Day 15. The difference in mean grade of ocular pain grade at Day 15 for KPI-121 1% dosed twice daily (BID) or 0.25% dosed four times daily (QID) compared with vehicle (either dosed BID or QID). Subjects were given the Subject-Rated Ocular Pain Assessment to subjectively rate their pain.

    Higher scores were worse outcomes.

    The following scoring scale was used for ocular pain:

    0 = None

    1. Minimal
    2. Mild
    3. Moderate
    4. Moderately Severe
    5. Severe

    Measured: Visit 6 (postoperative day 15)

Timeline

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

  1. First posted16 Jun 2014 (estimated)
  2. Study startMay 2014
  3. Primary completionDec 2014
  4. Study completionDec 2014

Resources

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
380 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02163824
Sponsor's protocol ID
KPI-121-C-001
Acronym
Hawaii-1
Status last verified
Jan 2021
First submitted
12 Jun 2014
Last updated
29 Jan 2021
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing KPI-121 0.25% and KPI-121 1.0% in people with Ocular Infections, Irritations and Inflammations, run by Kala Pharmaceuticals, Inc. at 23 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 29 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 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. Some participants in this study may receive a placebo. 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 22 Dec 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?

Resolution of Anterior Chamber Cells (time frame: Visit 5 (postoperative day 8) and Visit 6 (postoperative day 15)). The study lists 2 primary outcomes in all. 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 NCT02163824.

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 29 Jan 2021.

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