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Safety and Efficacy of KPI-121 in Subjects With Postsurgical Inflammation (Hawaii-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02163824
Recruitment Status : Completed
First Posted : June 16, 2014
Results First Posted : December 22, 2020
Last Update Posted : January 29, 2021
Sponsor:
Information provided by (Responsible Party):
Kala Pharmaceuticals, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Ocular Infections, Irritations and Inflammations Drug: KPI-121 0.25% Drug: KPI-121 1.0% Drug: Vehicle of KPI-121 0.25% Drug: Vehicle of KPI-121 1.0% Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 380 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III, Double-Masked, Randomized, Controlled Trial of KPI-121 in Postsurgical Inflammation
Study Start Date : May 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Arm Intervention/treatment
Active Comparator: KPI-121 0.25% QID
KPI-121 0.25% Ophthalmic Suspension dosed 4 times daily for 14 days after routine, uncomplicated surgery for cataract removal and intraocular lens implant.
Drug: KPI-121 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.
Other Names:
  • KPI-121 0.25% Ophthalmic Suspension
  • Loteprednol etabonate 0.25%

Active Comparator: KPI-121 1.0% BID
KPI-121 1.0% Ophthalmic Suspension dosed 2 times daily for 14 days after routine, uncomplicated surgery for cataract removal and intraocular lens implant.
Drug: KPI-121 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.
Other Names:
  • KPI-121 1.0% Ophthalmic Suspension
  • Loteprednol etabonate 1.0%

Placebo Comparator: Vehicle of KPI-121 0.25%
Vehicle 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.
Drug: Vehicle of KPI-121 0.25%
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 Name: Vehicle of KPI-121 0.25% Ophthalmic Suspension

Placebo Comparator: Vehicle of KPI-121 1.0%
Vehicle 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.
Drug: Vehicle of KPI-121 1.0%
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 Name: Vehicle of KPI-121 1.0% Ophthalmic Suspension




Primary Outcome Measures :
  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. 1 to 5 cells
    2. 6 to 15 cells
    3. 16 to 30 cells
    4. 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 Outcome Measures :
  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. 1 - 5 cells
    2. 6 - 15 cells
    3. 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. 1 - 5 cells
    2. 6 - 15 cells
    3. 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

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

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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02163824


Locations
Show Show 23 study locations
Sponsors and Collaborators
Kala Pharmaceuticals, Inc.
  Study Documents (Full-Text)

Documents provided by Kala Pharmaceuticals, Inc.:
Layout table for additonal information
Responsible Party: Kala Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02163824    
Other Study ID Numbers: KPI-121-C-001
First Posted: June 16, 2014    Key Record Dates
Results First Posted: December 22, 2020
Last Update Posted: January 29, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Kala Pharmaceuticals, Inc.:
postsurgical
postoperative
ocular
cataract
inflammation
pain
corticosteroid
Additional relevant MeSH terms:
Layout table for MeSH terms
Eye Infections
Inflammation
Pathologic Processes
Infections
Eye Diseases
Loteprednol Etabonate
Anti-Allergic Agents