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Completed

NCT Number: NCT02793817

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

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.

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Key information

Conditions

Post Surgical Ocular Inflammation and Pain Cataract Eye Diseases 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

Arizona Eye Center, Chandler, Arizona, 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 KPI-121 1.0% ophthalmic suspension versus placebo in subjects who require treatment of postoperative anterior ocular inflammation.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

KPI-121 1% Ophthalmic Suspension dosed BID

Drug

Other names: Loteprednol etabonate

Vehicle of KPI-121 Ophthalmic Suspension dosed BID

Drug

Other names: Placebo

Primary outcomes

  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 - 5 cells
    • = 6 - 15 cells
    • = 16 - 30 cells
    • = 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

    • = Minimal
    • = Mild
    • = Moderate
    • = Moderately Severe
    • = Severe

Secondary outcomes

  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

    • = Minimal
    • = Mild
    • = Moderate
    • = Moderately Severe
    • = 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

    • = Mild (trace to clearly noticeable, visible)
    • = Moderate (without plastic aqueous humor)
    • = Marked (with plastic aqueous humor)
    • = 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 - 5 cells
    • = 6 - 15 cells
    • = 16 - 30 cells
    • = greater than 30 cells

Sponsors and collaborators

Lead sponsor

Kala Pharmaceuticals, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 8, 2016
Registry last updated
Dec 16, 2020

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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