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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 2017

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.

Interventions

  • Drug: KPI-121 1% Ophthalmic Suspension dosed BID
  • Drug: Vehicle of KPI-121 Ophthalmic Suspension dosed BID

Arms, Groups and Cohorts

  • Active Comparator: KPI-121 1.0% Ophthalmic Suspension
    • dosed BID
  • Placebo Comparator: Vehicle of KPI-121 Ophthalmic Suspension
    • dosed BID

Clinical Trial Outcome Measures

Primary Measures

  • 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
  • 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 Measures

  • 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
  • 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)
  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Kala Pharmaceuticals, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor

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