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The primary purpose of this study is to determine the efficacy and safety of KPI-121 0.25% ophthalmic suspension compared to vehicle (placebo) in subjects who have a documented clinical diagnosis of dry eye disease. The product will be studied over 14 days, with 1-2 drops instilled in each eye four times daily (QID).
This is a Phase 3, multi-center, double-masked, randomized, vehicle-controlled, parallel-group study designed to evaluate the safety and efficacy of KPI-121 0.25% ophthalmic suspension versus vehicle in subjects with dry eye disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KPI-121 0.25% Ophthalmic Suspension | Active Comparator |
| |
| Vehicle of KPI-121 0.25% Ophthalmic Suspension | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KPI-121 0.25% Ophthalmic Suspension | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline/Visit 2 (Day 1) in Bulbar Conjunctival Hyperemia at Visit 4 (Day 15) | Comparison of mean change from baseline for bulbar conjunctival hyperemia in the study eye between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-4 grading scale. The grading scale was based on the Cornea and Contact Lens Research Unit Grading Scale where 0 = none, 1 = very slight, 2 = slight, 3 = moderate and 4 = severe. | Baseline/Visit 2 (Day 1) - Visit 4 (Day 15) |
| Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity at Visit 4 (Day 15) | Comparison of mean ocular discomfort between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse. | Baseline/Visit 2 (Day 1) - Visit 4 (Day 15) |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects With ≥ 1 Unit Improvement From Baseline/Visit 2 (Day 1) in Bulbar Conjunctival Hyperemia Worst Region at Visit 4 (Day 15) | Proportion of subjects with ≥1 improvement from baseline in conjunctival hyperemia scores in the study eye. The grading scale was based on the Cornea and Contact Lens Research Unit Grading Scale where 0 = none, 1 = very slight, 2 = slight, 3 = moderate and 4 = severe. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB School of Optometry | Birmingham | Alabama | 35294-0010 | United States | ||
| Arizona Eye Center |
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909 subjects were randomized, 4 of which were not included in any analysis population as agreed upon with the FDA. 3 individuals had participated in more than one study therefore the data for their second-participation were not included and 1 individual did not receive treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | KPI-121 0.25% Ophthalmic Suspension | Participants randomized to KPI-121 0.25% Ophthalmic Suspension |
| FG001 | Vehicle of KPI-121 0.25% Ophthalmic Suspension | Participants randomized to Vehicle of KPI-121 0.25% Ophthalmic Suspension |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 6, 2017 |
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| Vehicle of KPI-121 0.25% Ophthalmic Suspension |
| Drug |
|
|
| Baseline/Visit 2 (Day 1) - Visit 4 (Day 15) |
| Change From Baseline/ Visit 2 (Day 1) in Ocular Discomfort Severity Scores at Visit 3 (Day 8) | Comparison of ocular discomfort scores between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse using 3-day mean scores. | Baseline/Visit 2 (Day 1) - Visit 3 (Day 8) |
| Change From Baseline/Week 2 (Day 1) in Ocular Discomfort Scores to Day 4 | Comparison of mean ocular discomfort between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse. | Baseline/Visit 2 (Day 1) - Day 4 |
| Change From Baseline/Week 2 (Day 1) in Ocular Discomfort Severity at Visit 4 (Day 15) in a Subgroup | Comparison of mean ocular discomfort between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse, in a sub-group of participants with more severe ocular discomfort at baseline, using 3 day means. | Baseline/Visit 2 (Day 1) - Visit 4 (Day 15) |
| Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity Scores at Day 3 (Diary) | Comparison of mean ocular discomfort severity between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse. | Baseline/Visit 2 (Day 1) - Day 3 |
| Change From Baseline/Visit 2 (Day 1) in Eye Dryness Scores at Visit 4 (Day 15) | Comparison of mean eye dryness between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse. | Baseline/Visit 2 (Day 1) - Visit 4 (Day 15) |
| Change From Baseline/Visit 2 (Day 1) in Eye Dryness Scores at Visit 3 (Day 8) | Comparison of mean eye dryness between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse. | Baseline/Visit 2 (Day 1) - Visit 3 (Day 8) |
| Ocular Discomfort Severity Scores on Day 2 (Diary) Minus Baseline/Visit 2 (Day 1) | Comparison of mean ocular discomfort between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse. | Baseline/Visit 2 (Day 1) - Day 1 |
| Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Frequency Scores at Visit 4 (Day 15) | Comparison of mean ocular discomfort frequency between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse. | Baseline/Visit 2 (Day 1) - Visit 4 (Day 15) |
| Change From Baseline/Visit 2 (Day 1) in Subject-rated Ocular Discomfort Frequency Scores at Visit 3 (Day 8) | Comparison of mean ocular discomfort frequency between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse. | Baseline/Visit 2 (Day 1) - Visit 3 (Day 8) |
| Change From Baseline/Visit 2 (Day 1) in Inferior Corneal Fluorescein Staining Score at Visit 4 (Day 15) | Comparison of mean corneal fluorescein staining in the study eye between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using methods developed by the National Eye Institute (NEI) Dry Eye Workshop in evaluating 5 regions of the cornea (superior, inferior, nasal, temporal and central) using a 0-3 grading scale, where 0 = no visible staining, 1 = Mild, 2 = moderate and 3 = severe. | Baseline/Visit 2 (Day 1) - Visit 4 (Day 15) |
| Change From Baseline/Visit 2 (Day 1) in Nasal Corneal Fluorescein Staining Score at Visit 4 (Day 15) | Comparison of mean nasal corneal fluorescein staining in the study eye between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using methods developed by the National Eye Institute (NEI) Dry Eye Workshop in evaluating 5 regions of the cornea (superior, inferior, nasal, temporal and central) using a 0-3 grading scale, where 0 = no visible staining, 1 = Mild, 2 = moderate and 3 = severe. | Baseline/Visit 2 (Day 1) - Visit 4 (Day 15) |
| Chandler |
| Arizona |
| 85225 |
| United States |
| NEA Baptist Clinic | Jonesboro | Arkansas | 72401 | United States |
| Sall Research Medical Center | Artesia | California | 90701 | United States |
| Milton M. Hom, OD, FAAO | Azusa | California | 91702 | United States |
| Family Eye Care Center | Campbell | California | 95008 | United States |
| Orange County Ophthalmology | Garden Grove | California | 92843 | United States |
| Lugene Eye Institute | Glendale | California | 91204 | United States |
| The Gavin Herbert Eye Institute | Irvine | California | 92697-4375 | United States |
| Macy Eye Center | Los Angeles | California | 90048 | United States |
| Advanced Vision Care | Los Angeles | California | 90067 | United States |
| North Valley Eye Medical Group | Mission Hills | California | United States |
| Eye Research Foundation | Newport Beach | California | 92663 | United States |
| Arch Health Partners | Poway | California | 92064 | United States |
| Martel Eye Medical Group | Rancho Cordova | California | 95670 | United States |
| Shasta Eye Medical Group, Inc | Redding | California | 96002 | United States |
| West Coast Eye Care Associates | San Diego | California | 92115 | United States |
| Wolstan & Goldberg Eye Associates | Torrance | California | 90505 | United States |
| Michael K Tran, M.D., Inc. | Westminster | California | 92683 | United States |
| Hernando Eye Institute | Brooksville | Florida | 34613 | United States |
| Central Florida Eye Associates | Lakeland | Florida | 33805 | United States |
| Shettle Eye Research, Inc | Largo | Florida | 33773 | United States |
| International Eye Associates PA | Ormond Beach | Florida | 32174 | United States |
| Perez Eye Center/International Research Center | Tampa | Florida | 33603 | United States |
| Eye Care Centers Management, Inc. (Clayton Eye Center) | Morrow | Georgia | 30260 | United States |
| Chicago Cornea Consultants, Ltd. | Hoffman Estates | Illinois | 60169 | United States |
| Price Vision Group | Indianapolis | Indiana | 46260 | United States |
| John-Kenyon American Eye Institute | New Albany | Indiana | 47150 | United States |
| Cincinnati Eye Institute | Edgewood | Kentucky | 41017 | United States |
| Koffler Vision Group | Lexington | Kentucky | 40509 | United States |
| The Eye Care Institute | Louisville | Kentucky | 40206 | United States |
| Taustine Eye Center | Louisville | Kentucky | 40217 | United States |
| Ophthalmic Consultants of Boston | Boston | Massachusetts | 02114 | United States |
| Minnesota Eye Consultants, PA | Bloomington | Minnesota | 55431 | United States |
| Tauber Eye Center | Kansas City | Missouri | 64111 | United States |
| Tekwani Vision Center | St Louis | Missouri | 63128 | United States |
| Comprehensive Eye Care, Ltd. / Vision Research Institute, LLC | Washington | Missouri | 63090 | United States |
| Abrams Eye Institute | Las Vegas | Nevada | 89148 | United States |
| Raymond Fong, MDPC | New York | New York | 10013 | United States |
| Ophthalmic Consultants of Long Island | Rockville Centre | New York | 11570 | United States |
| Cornerstone Eye Care | High Point | North Carolina | 27262 | United States |
| James D Branch MD | Winston-Salem | North Carolina | 27101 | United States |
| Comprehensive Eye Care of Central Ohio | Westerville | Ohio | 43082 | United States |
| Drs. Fine, Hoffman & Sims, LLC | Eugene | Oregon | 97401 | United States |
| Scott & Christie and Associates, PC | Cranberry Township | Pennsylvania | 16066 | United States |
| Eye Care Specialists | Kingston | Pennsylvania | 18704 | United States |
| Bucci Laser Vision Institute | Wilkes-Barre | Pennsylvania | 18702 | United States |
| Chattanooga Eye Institute, P.C. | Chattanooga | Tennessee | 37411 | United States |
| Total Eye Care, PA | Memphis | Tennessee | 38119 | United States |
| Toyos Clinic | Nashville | Tennessee | 37215 | United States |
| Texan Eye, PA / Keystone Research, Ltd | Austin | Texas | 78731 | United States |
| The Cataract and Glaucoma Center | El Paso | Texas | 79902 | United States |
| Houston Eye Associates | Houston | Texas | 77024 | United States |
| Advanced Laser Vision & Surgical Institute, Intouch Clinical Research Center | Houston | Texas | 77034 | United States |
| Whitsett Vision Group | Houston | Texas | 77055 | United States |
| The Ocular Surface Institute (TOSI), University of Houston | Houston | Texas | 77204 | United States |
| Brazosport Eye Institute | Lake Jackson | Texas | 77566 | United States |
| Kozlovsky Delay & Winter Eye Consultants, LLC | San Antonio | Texas | 78230 | United States |
| Hoopes Vision | Draper | Utah | 84020 | United States |
| Virginia Eye Consultants | Norfolk | Virginia | 23502 | United States |
| Spokane Eye Clinical Research | Spokane | Washington | 99204 | United States |
| Regional Eye Associates | Morgantown | West Virginia | 26505 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | KPI-121 0.25% Ophthalmic Suspension | Participants randomized to KPI-121 0.25% Ophthalmic Suspension |
| BG001 | Vehicle of KPI-121 0.25% Ophthalmic Suspension | Participants randomized to Vehicle of KPI-121 0.25% Ophthalmic Suspension |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline/Visit 2 (Day 1) in Bulbar Conjunctival Hyperemia at Visit 4 (Day 15) | Comparison of mean change from baseline for bulbar conjunctival hyperemia in the study eye between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-4 grading scale. The grading scale was based on the Cornea and Contact Lens Research Unit Grading Scale where 0 = none, 1 = very slight, 2 = slight, 3 = moderate and 4 = severe. | Intent to Treat population minus subjects in each treatment group that discontinued the study by this time point or otherwise did not have this assessment completed. | Posted | Mean | Standard Deviation | score on a scale | Baseline/Visit 2 (Day 1) - Visit 4 (Day 15) |
|
|
| ||||||||||||||||||||||||||||
| Primary | Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity at Visit 4 (Day 15) | Comparison of mean ocular discomfort between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse. | Intent to Treat population minus subjects in each treatment group that discontinued the study by this time point or otherwise did not have this assessment completed. | Posted | Mean | Standard Deviation | score on a scale | Baseline/Visit 2 (Day 1) - Visit 4 (Day 15) |
|
| |||||||||||||||||||||||||||||
| Secondary | Proportion of Subjects With ≥ 1 Unit Improvement From Baseline/Visit 2 (Day 1) in Bulbar Conjunctival Hyperemia Worst Region at Visit 4 (Day 15) | Proportion of subjects with ≥1 improvement from baseline in conjunctival hyperemia scores in the study eye. The grading scale was based on the Cornea and Contact Lens Research Unit Grading Scale where 0 = none, 1 = very slight, 2 = slight, 3 = moderate and 4 = severe. | Intent to Treat population minus subjects in each treatment group that discontinued the study by this time point or otherwise did not have this assessment completed. | Posted | Count of Participants | Participants | Baseline/Visit 2 (Day 1) - Visit 4 (Day 15) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline/ Visit 2 (Day 1) in Ocular Discomfort Severity Scores at Visit 3 (Day 8) | Comparison of ocular discomfort scores between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse using 3-day mean scores. | Intent to Treat population minus subjects in each treatment group that discontinued the study by this time point or otherwise did not have this assessment completed. | Posted | Mean | Standard Deviation | score on a scale | Baseline/Visit 2 (Day 1) - Visit 3 (Day 8) |
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline/Week 2 (Day 1) in Ocular Discomfort Scores to Day 4 | Comparison of mean ocular discomfort between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse. | Intent to Treat population minus subjects in each treatment group that discontinued the study by this time point or otherwise did not have this assessment completed. | Posted | Mean | Standard Deviation | score on a scale | Baseline/Visit 2 (Day 1) - Day 4 |
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline/Week 2 (Day 1) in Ocular Discomfort Severity at Visit 4 (Day 15) in a Subgroup | Comparison of mean ocular discomfort between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse, in a sub-group of participants with more severe ocular discomfort at baseline, using 3 day means. | Sub-group of Intent to Treat population with more severe ocular discomfort minus subjects in each treatment group that discontinued the study by this time point or otherwise did not have this assessment completed. | Posted | Mean | Standard Deviation | score on a scale | Baseline/Visit 2 (Day 1) - Visit 4 (Day 15) |
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity Scores at Day 3 (Diary) | Comparison of mean ocular discomfort severity between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse. | Intent to Treat population minus subjects in each treatment group that discontinued the study by this time point or otherwise did not have this assessment completed. | Posted | Mean | Standard Deviation | score on a scale | Baseline/Visit 2 (Day 1) - Day 3 |
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline/Visit 2 (Day 1) in Eye Dryness Scores at Visit 4 (Day 15) | Comparison of mean eye dryness between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse. | Intent to Treat population minus subjects in each treatment group that discontinued the study by this time point or otherwise did not have this assessment completed. | Posted | Mean | Standard Deviation | score on a scale | Baseline/Visit 2 (Day 1) - Visit 4 (Day 15) |
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline/Visit 2 (Day 1) in Eye Dryness Scores at Visit 3 (Day 8) | Comparison of mean eye dryness between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse. | Intent to Treat population minus subjects in each treatment group that discontinued the study by this time point or otherwise did not have this assessment completed. | Posted | Mean | Standard Deviation | score on a scale | Baseline/Visit 2 (Day 1) - Visit 3 (Day 8) |
|
| |||||||||||||||||||||||||||||
| Secondary | Ocular Discomfort Severity Scores on Day 2 (Diary) Minus Baseline/Visit 2 (Day 1) | Comparison of mean ocular discomfort between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse. | Intent to Treat population minus subjects in each treatment group that discontinued the study by this time point or otherwise did not have this assessment completed. | Posted | Mean | Standard Deviation | score on a scale | Baseline/Visit 2 (Day 1) - Day 1 |
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Frequency Scores at Visit 4 (Day 15) | Comparison of mean ocular discomfort frequency between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse. | Intent to Treat population minus subjects in each treatment group that discontinued the study by this time point or otherwise did not have this assessment completed. | Posted | Mean | Standard Deviation | score on a scale | Baseline/Visit 2 (Day 1) - Visit 4 (Day 15) |
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline/Visit 2 (Day 1) in Subject-rated Ocular Discomfort Frequency Scores at Visit 3 (Day 8) | Comparison of mean ocular discomfort frequency between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse. | Intent to Treat population minus subjects in each treatment group that discontinued the study by this time point or otherwise did not have this assessment completed. | Posted | Mean | Standard Deviation | score on a scale | Baseline/Visit 2 (Day 1) - Visit 3 (Day 8) |
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline/Visit 2 (Day 1) in Inferior Corneal Fluorescein Staining Score at Visit 4 (Day 15) | Comparison of mean corneal fluorescein staining in the study eye between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using methods developed by the National Eye Institute (NEI) Dry Eye Workshop in evaluating 5 regions of the cornea (superior, inferior, nasal, temporal and central) using a 0-3 grading scale, where 0 = no visible staining, 1 = Mild, 2 = moderate and 3 = severe. | Intent to Treat population minus subjects in each treatment group that discontinued the study by this time point or otherwise did not have this assessment completed. | Posted | Mean | Standard Deviation | score on a scale | Baseline/Visit 2 (Day 1) - Visit 4 (Day 15) |
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline/Visit 2 (Day 1) in Nasal Corneal Fluorescein Staining Score at Visit 4 (Day 15) | Comparison of mean nasal corneal fluorescein staining in the study eye between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using methods developed by the National Eye Institute (NEI) Dry Eye Workshop in evaluating 5 regions of the cornea (superior, inferior, nasal, temporal and central) using a 0-3 grading scale, where 0 = no visible staining, 1 = Mild, 2 = moderate and 3 = severe. | Intent to Treat population minus subjects in each treatment group that discontinued the study by this time point or otherwise did not have this assessment completed. | Posted | Mean | Standard Deviation | score on a scale | Baseline/Visit 2 (Day 1) - Visit 4 (Day 15) |
|
|
Adverse events were collected from Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Both treatment-related and non-treatment-related adverse events are reported here.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | KPI-121 0.25% Ophthalmic Suspension | Participants randomized to KPI-121 0.25% Ophthalmic Suspension | 0 | 452 | 3 | 452 | 57 | 452 |
| EG001 | Vehicle of KPI-121 0.25% Ophthalmic Suspension | Participants randomized to Vehicle of KPI-121 0.25% Ophthalmic Suspension | 0 | 453 | 0 | 453 | 44 | 453 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| diverticulum intestinal | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| hip fracture | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear pain | Ear and labyrinth disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Eye pruritus | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Conjunctival hyperaemia | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Eye irritation | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Conjunctival oedema | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Eye discharge | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Eyelid pruritus | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Iritis | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Ocular hypertension | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Photophobia | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Vision acuity reduced | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Corneal infiltrates | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Gastroesophogeal reflux disease | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Oesophageal rupture | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Instillation site pain | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Instillation site discharge | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Instillation site irritation | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Instillation site pruritus | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Streptococcal infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Body tinea | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Vaginal infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| Intraocular pressure increased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Ophthalmoplegic migraine | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Paranasal sinus hypersecretion | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
|
The agreement between the Principal Investigator and the Sponsor restricts the PI's rights to discuss or publish trial results until after the first to occur of the following:
(a) publication of such multi-center clinical trial results; (b) notification by sponsor that such a multi-center clinical trial submission is no longer planned; or ( c) the eighteen ( 18) month anniversary of the completion, abandonment or termination of such multi-center clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP Clinical Development | Kala Pharmaceuticals, Inc. | (781) 996-5252 | Results007@kalarx.com |
| Sep 21, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D007638 | Keratoconjunctivitis Sicca |
| D010146 | Pain |
| D006940 | Hyperemia |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D007637 | Keratoconjunctivitis |
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D007634 | Keratitis |
| D003316 | Corneal Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069559 | Loteprednol Etabonate |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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