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

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

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.

Condition or disease Intervention/treatment Phase
Post Surgical Ocular Inflammation and Pain Drug: KPI-121 1% Ophthalmic Suspension dosed BID Drug: Vehicle of KPI-121 Ophthalmic Suspension dosed BID 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 KPI-121 1.0% ophthalmic suspension versus placebo in subjects who require treatment of postoperative anterior ocular inflammation.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 520 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : June 2016
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: KPI-121 1.0% Ophthalmic Suspension
dosed BID
Drug: KPI-121 1% Ophthalmic Suspension dosed BID
Other Name: Loteprednol etabonate

Placebo Comparator: Vehicle of KPI-121 Ophthalmic Suspension
dosed BID
Drug: Vehicle of KPI-121 Ophthalmic Suspension dosed BID
Other Name: Placebo




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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)

  3. 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



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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

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.

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): NCT02793817


  Show 35 Study Locations
Sponsors and Collaborators
Kala Pharmaceuticals, Inc.
  Study Documents (Full-Text)

Documents provided by Kala Pharmaceuticals, Inc.:
Study Protocol  [PDF] February 24, 2017
Statistical Analysis Plan  [PDF] April 19, 2017


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Responsible Party: Kala Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02793817     History of Changes
Other Study ID Numbers: KPI-121-C-005
First Posted: June 8, 2016    Key Record Dates
Results First Posted: April 17, 2019
Last Update Posted: April 17, 2019
Last Verified: October 2018
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:
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Inflammation
Pathologic Processes
Loteprednol Etabonate
Anti-Allergic Agents