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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Post Surgical Ocular Inflammation and Pain

Intervention / Treatment
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* Drug: KPI-121 1% Ophthalmic Suspension dosed BID
* Drug: Vehicle of KPI-121 Ophthalmic Suspension dosed BID


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: KPI-121 1.0% Ophthalmic Suspension<br>dosed BID | Drug: KPI-121 1% Ophthalmic Suspension dosed BID<br> <br> * Other names: Loteprednol etabonate;|
| Placebo Comparator: Vehicle of KPI-121 Ophthalmic Suspension<br>dosed BID | Drug: Vehicle of KPI-121 Ophthalmic Suspension dosed BID<br> <br> * Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete Resolution of Anterior Chamber (AC) Cells at Day 8 | 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 | Visit 5 (Day 8) maintained through Visit 6 (Day 15) | 
| Complete Resolution of Ocular Pain at Day 8 | 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 | Visit 5 (Day 8) maintained through Visit 6 (Day 15) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete Resolution of Ocular Pain at Day 4 | 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 | Visit 4 (Day 4) maintained through Visit 6 (Day 15) | 
| Complete Resolution of Anterior Chamber (AC) Flare at Day 4 | 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) | Visit 4 (Day 4) maintained through Visit 6 (Day 15) | 
| Change From Baseline (BL) Anterior Chamber (AC) Cells at 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 | Visit 1 (Baseline) and Visit 4 (Day 4) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postsurgical, postoperative, ocular, cataract, inflammation, pain, corticosteroid