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Completed

NCT Number: NCT02163824

Safety and Efficacy of KPI-121 in Subjects With 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.

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Key information

Conditions

Ocular Infections, Irritations and Inflammations Cataract Eye Diseases Eye Infections Infections Inflammation Lens Diseases Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sall Research Medical Center, Artesia, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

FURTHER STUDY DETAILS PROVIDED BY KALA PHARMACEUTICALS, INC.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

KPI-121 0.25%

Drug

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.

Other names: KPI-121 0.25% Ophthalmic Suspension, Loteprednol etabonate 0.25%

KPI-121 1.0%

Drug

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.

Other names: KPI-121 1.0% Ophthalmic Suspension, Loteprednol etabonate 1.0%

Vehicle of KPI-121 0.25%

Drug

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.

Other names: Vehicle of KPI-121 0.25% Ophthalmic Suspension

Vehicle of KPI-121 1.0%

Drug

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.

Other names: Vehicle of KPI-121 1.0% Ophthalmic Suspension

Primary outcomes

  1. Resolution of Anterior Chamber Cells

    Time frame: Visit 5 (postoperative day 8) and Visit 6 (postoperative day 15)

    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 to 5 cells
    • 6 to 15 cells
    • 16 to 30 cells
    • greater than 30 cells

  2. Resolution of Ocular Pain

    Time frame: Visit 5 (postoperative day 8) and Visit 6 (postoperative day 15)

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

Secondary outcomes

  1. Anterior Chamber Cell Grade at Visit 5.

    Time frame: Visit 5 (postoperative day 8)

    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 - 5 cells
    • 6 - 15 cells
    • 16 - 30 cells 4 = greater than 30 cells

  2. Anterior Chamber Cell Grade at Visit 6.

    Time frame: Visit 6 (postoperative day 15)

    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 - 5 cells
    • 6 - 15 cells
    • 16 - 30 cells 4 = greater than 30 cells

  3. Ocular Pain Grades at Day 8.

    Time frame: Visit 5 (postoperative 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

    • Minimal
    • Mild
    • Moderate
    • Moderately Severe
    • Severe

  4. Ocular Pain Grades at Day 15.

    Time frame: Visit 6 (postoperative 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

    • Minimal
    • Mild
    • Moderate
    • Moderately Severe
    • Severe

Sponsors and collaborators

Lead sponsor

Kala Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Acronym: Hawaii-1

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jun 16, 2014
Registry last updated
Jan 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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