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

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: NCT02793817
Recruitment Status : Completed
First Posted : June 8, 2016
Results First Posted : April 17, 2019
Last Update Posted : December 16, 2020
Sponsor:
Information provided by (Responsible Party):
Kala Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE June 3, 2016
First Posted Date  ICMJE June 8, 2016
Results First Submitted Date  ICMJE October 25, 2018
Results First Posted Date  ICMJE April 17, 2019
Last Update Posted Date December 16, 2020
Actual Study Start Date  ICMJE June 2016
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 28, 2019)
  • Complete Resolution of Anterior Chamber (AC) Cells at Day 8 [ Time Frame: Visit 5 (Day 8) maintained through Visit 6 (Day 15) ]
    Number and percentage of subjects with complete resolution of AC cells in the surgical eye (study eye) at Day 8 maintained through Day 15, without receiving rescue medication prior to Day 15, for KPI-121 1% dosed twice daily (BID) compared with vehicle dosed BID. 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
  • Complete Resolution of Ocular Pain at Day 8 [ Time Frame: Visit 5 (Day 8) maintained through Visit 6 (Day 15) ]
    Number and percentage of subjects with complete resolution of ocular pain in the surgical eye (study eye) at Day 8 maintained through Day 15, without receiving rescue medication prior to Day 15, for KPI-121 1% dosed twice daily (BID) compared with vehicle dosed BID. Subjects were given the Subject-Rated Ocular Pain Assessment to subjectively rate their pain at Days 1, 4, 8, 15, and the follow-up visit between Days 17 and 19. 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
Original Primary Outcome Measures  ICMJE
 (submitted: June 3, 2016)
  • Proportion of study eyes with complete resolution of anterior chamber cells (cell score = 0) in the study eye [ Time Frame: Visit 5 (Day 8) maintained through Visit 6 (Day 15) ]
  • Proportion of study eyes with complete resolution of ocular pain (grade = 0) in the study eye [ Time Frame: Visit 5 (Day 8) maintained through Visit 6 (Day 15)] ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2019)
  • Complete Resolution of Ocular Pain at Day 4 [ Time Frame: Visit 4 (Day 4) maintained through Visit 6 (Day 15) ]
    Number and percentage of subjects with complete resolution of ocular pain in the surgical eye (study eye) at Day 4 maintained through Day 15, without receiving rescue medication prior to Day 15, for KPI-121 1% dosed twice daily (BID) compared with vehicle dosed BID. Subjects were given the Subject-Rated Ocular Pain Assessment to subjectively rate their pain at Days 1, 4, 8, 15, and the follow-up visit between Days 17 and 19. 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
  • Complete Resolution of Anterior Chamber (AC) Flare at Day 4 [ Time Frame: Visit 4 (Day 4) maintained through Visit 6 (Day 15) ]
    Number and percentage of subjects with complete resolution of AC flare in the surgical eye (study eye) at Day 4 maintained through Day 15, without receiving rescue medication prior to Day 15, for KPI-121 1% dosed twice daily (BID) compared with vehicle dosed BID. Investigators were asked to grade AC flare based on the following scale wherein higher scores indicate a higher degree of flare present and a decrease across time indicates the condition is getting better. Anterior Chamber Flare 0 = None
    1. = Mild (trace to clearly noticeable, visible)
    2. = Moderate (without plastic aqueous humor)
    3. = Marked (with plastic aqueous humor)
    4. = Severe (with fibrin deposits and/or clots)
  • Change From Baseline (BL) Anterior Chamber (AC) Cells at Day 4 [ Time Frame: Visit 1 (Baseline) and Visit 4 (Day 4) ]
    The difference in mean changes from BL in AC cell count grade at Day 4 for KPI-121 1% dosed twice daily (BID) compared with vehicle dosed BID. 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
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of KPI-121 in Subjects With Postsurgical Inflammation and Pain
Official Title  ICMJE A Phase 3, Double-Masked, Randomized, Controlled Study to Evaluate the Safety and Efficacy of KPI-121 1.0% Ophthalmic Suspension in Subjects With Postsurgical Inflammation and Pain
Brief Summary The primary objective of the study is to investigate the efficacy and safety of KPI-121 1.0% ophthalmic suspension compared to placebo in subjects who have undergone cataract surgery.
Detailed Description This is a Phase III, multicenter, double-masked, randomized, placebo-controlled, parallel-group study designed to evaluate the efficacy and safety of KPI-121 1.0% ophthalmic suspension versus placebo in subjects who require treatment of postoperative anterior ocular inflammation.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Post Surgical Ocular Inflammation and Pain
Intervention  ICMJE
  • Drug: KPI-121 1% Ophthalmic Suspension dosed BID
    Other Name: Loteprednol etabonate
  • Drug: Vehicle of KPI-121 Ophthalmic Suspension dosed BID
    Other Name: Placebo
Study Arms  ICMJE
  • Active Comparator: KPI-121 1.0% Ophthalmic Suspension
    dosed BID
    Intervention: Drug: KPI-121 1% Ophthalmic Suspension dosed BID
  • Placebo Comparator: Vehicle of KPI-121 Ophthalmic Suspension
    dosed BID
    Intervention: Drug: Vehicle of KPI-121 Ophthalmic Suspension dosed BID
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 1, 2017)		 520
Original Estimated Enrollment  ICMJE
 (submitted: June 3, 2016)		 350
Actual Study Completion Date  ICMJE March 2017
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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, intraocular pressure (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 18 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02793817
Other Study ID Numbers  ICMJE KPI-121-C-005
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Kala Pharmaceuticals, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Kala Pharmaceuticals, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Kala Pharmaceuticals, Inc.
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP