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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 bulbar conjunctival hyperemia 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) and to 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 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) and to Visit 4 (Day 15) |
| Change From Baseline/Visit 2 (Day 1) in Corneal Fluorescein Staining Score at Visit 4 (Day 15) | Comparison of mean corneal fluorescein staining 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) and to Visit 4 (Day 15) |
| Change From Baseline/Visit 2 (Day 1) Ocular Discomfort Severity at Visit 4 (Day 15) in the Subgroup of Participants With More Severe Ocular Discomfort | 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, in a sub-group of participants with more severe ocular discomfort at baseline. | Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Conjunctival Hyperemia Scores at Visit 4 (Day 15) in the Subgroup of Participants With More Severe Ocular Discomfort at Baseline (Day 1) | Comparison of mean bulbar conjunctival hyperemia 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cornea and Cataract Consultants of Arizona | Phoenix | Arizona | 85032 | United States | ||
| Schwartz Laser Eye Center |
918 subjects were randomized, 3 of which were not included in any analysis population as they had participated in more than one study. The data for the second-participation for these 3 individuals were not included in any analysis population as agreed upon with the FDA.
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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) and to Visit 4 (Day 15) |
| Proportion of Subjects With ≥1 Improvement in Conjunctival Hyperemia at Visit 4 (Day 15) | Proportion of subjects with ≥1 improvement from baseline in conjunctival hyperemia scores. 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) and to Visit 4 (Day 15) |
| Change From Baseline/Visit 2 (Day 1) Conjunctival Hyperemia Scores at Visit 4 (Day 15) for the Mean of All Regions (Nasal, Temporal, Frontal) | Comparison of mean bulbar conjunctival hyperemia 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) and to Visit 4 (Day 15) |
| Change in Ocular Discomfort Severity Scores Prior to Visit 3 (Day 8) Minus the Mean of the Scores to Baseline/Visit 2 (Day 1) | 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) and to Visit 3 (Day 8) |
| Change in Ocular Discomfort Severity Scores Prior to Visit 3 (Day 8) Minus Baseline/Visit 2 (Day 1) in the Subgroup of Participants With More Severe Ocular Discomfort. | 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) and to Visit 3 (Day 8) |
| Change in Ocular Discomfort Severity Scores on Day 4 (Diary) Minus Baseline/Visit 2 (Day 1) | 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) and to Visit 3 (Day 8) |
| Change in Ocular Discomfort Severity Scores on Day 4 Day 4 (Diary) Minus Baseline/Visit 2 (Day 1) in the Subgroup of Participants With More Severe Ocular Discomfort | 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, in a sub-group of participants with more severe ocular discomfort at baseline. | Baseline/Visit 2 (Day 1) and to Visit 3 (Day 8) |
| Change From Baseline/Visit 2 (Day 1) in Conjunctival Hyperemia Scores With a Day 1 Conjunctival Hyperemia Score of ≥ 2 in the Subgroup of Participants With More Severe Ocular Discomfort | Comparison of mean bulbar conjunctival hyperemia between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-4 grading scale in a sub-group of participants with more severe ocular discomfort at baseline.. 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) and to Visit 4 (Day 15) |
| Subjects With a Grade of 0 in Conjunctival Hyperemia Score at Visit 4 (Day 15) | Comparison of mean bulbar conjunctival hyperemia 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 | Visit 4 (Day 15) |
| Scottsdale |
| Arizona |
| 85260 |
| United States |
| Eyecare Arkansas, P.A. | Little Rock | Arkansas | 72205 | United States |
| Little Rock Eye Clinic, LLP | Little Rock | Arkansas | 72205 | United States |
| Sall Research Medical Center | Artesia | California | 90701 | United States |
| Orange County Ophthalmology Medical Group | Garden Grove | California | 92843 | United States |
| United Medical Research Institute | Inglewood | California | 90301 | United States |
| North Valley Eye Medical Group | Mission Hills | California | 91345 | United States |
| Montebello Medical Center, Inc. | Montebello | California | 90640 | United States |
| LoBue Laser and Eye Medical Center | Murrieta | California | 92562 | United States |
| Eye Research Foundation | Newport Beach | California | 92663 | United States |
| Pendleton Eye Center | Oceanside | California | 92056 | United States |
| North Bay Eye Associates, Inc. | Petaluma | California | 94954 | United States |
| Martel Eye Medical Group | Rancho Cordova | California | 95670 | United States |
| Sacramento Eye Consultants | Sacramento | California | 95815 | United States |
| Eye Center of Northern Colorado, PC | Fort Collins | Colorado | 80525 | United States |
| Corneal Consultants of Colorado | Littleton | Colorado | 80209 | United States |
| The Eye Center of Southern CT, P.C. | Hamden | Connecticut | 06518 | United States |
| Florida Eye Microsurgical Institute, Inc. | Boynton Beach | Florida | 33426 | United States |
| Eye Associates of Fort Myers | Fort Myers | Florida | 33901 | United States |
| Shettle Eye Research, Inc. | Largo | Florida | 33773 | United States |
| Atlantic Eye Center | Palm Coast | Florida | 32137 | United States |
| The Eye Center of North Florida | Panama City | Florida | 32405 | United States |
| Dixon Eye Care | Albany | Georgia | 31701 | United States |
| Jacksoneye, S. C. | Lake Villa | Illinois | 60046 | United States |
| Midwest Cornea Associates, LLC | Indianapolis | Indiana | 46290 | United States |
| Stiles EyeCare Excellence and Glaucoma Institute | Overland Park | Kansas | 66213 | United States |
| Clinical Eye Research of Boston | Winchester | Massachusetts | 01890 | United States |
| Chu Vision Institute | Bloomington | Minnesota | 55420 | United States |
| Lifelong Vision Foundation at Pepose Vision Institute | Chesterfield | Missouri | 63017 | United States |
| Ophthalmology Associates | St Louis | Missouri | 63131 | United States |
| Ophthalmology Consultants, Ltd. | St Louis | Missouri | 63131 | United States |
| Wellish Vision Institute | Las Vegas | Nevada | 89119 | United States |
| Matossian Eye Associates | Pennington | New Jersey | 08534 | United States |
| Rochester Ophthalmological Group, PC | Rochester | New York | 14618 | United States |
| Cornea Consultants of Albany | Slingerlands | New York | 12159 | United States |
| South Shore Eye Center, LLP | Wantagh | New York | 11793 | United States |
| Mundorf Eye Center | Charlotte | North Carolina | 28204 | United States |
| Firozvi Research, LLC / North Carolina Eye, Ear, Nose & Throat | Durham | North Carolina | 27704 | United States |
| Eyecare Center | Raleigh | North Carolina | 27603 | United States |
| Bergstrom Eye Research | Fargo | North Dakota | 58103 | United States |
| Abrams Eye Center | Cleveland | Ohio | 44115 | United States |
| Opthalamic Surgeons & Consultants of Ohio | Columbus | Ohio | 43215 | United States |
| Apex Eye | Mason | Ohio | 45040 | United States |
| Roseburg Research Associates, LLC | Roseburg | Oregon | 97471 | United States |
| Scott & Christie and Associates, PC | Cranberry Township | Pennsylvania | 16066 | United States |
| Conestoga Eye | Lancaster | Pennsylvania | 17601 | United States |
| UPMC Eye Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Black Hills Regional Eye Institute | Rapid City | South Dakota | 57701 | United States |
| Total Eye Care, PA | Memphis | Tennessee | 38119 | United States |
| Hill Country Eye Center | Cedar Park | Texas | 78613 | United States |
| Houston Eye Associates | Houston | Texas | 77025 | United States |
| The Eye Clinic of Texas, Affiliate of Houston Eye Associates | League City | Texas | 77573 | United States |
| Lake Travis Eye and Laser Center | Leander | Texas | 78641 | United States |
| Eye Clinics of South Texas | San Antonio | Texas | 78209 | United States |
| R and R Eye Research, LLC | San Antonio | Texas | 78229 | United States |
| Keystone Research - Medical Center Ophthalmology Associates | San Antonio | Texas | 78240 | United States |
| Tanner Clinic | Layton | Utah | 84041 | United States |
| See Clearly Vision | McLean | Virginia | 22102 | United States |
| Virginia Eye Consultants | Norfolk | Virginia | 23502 | 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 bulbar conjunctival hyperemia 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) and to 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 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) and to Visit 4 (Day 15) |
|
| |||||||||||||||||||||||||||||
| Primary | Change From Baseline/Visit 2 (Day 1) in Corneal Fluorescein Staining Score at Visit 4 (Day 15) | Comparison of mean corneal fluorescein staining 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) and to Visit 4 (Day 15) |
|
| |||||||||||||||||||||||||||||
| Primary | Change From Baseline/Visit 2 (Day 1) Ocular Discomfort Severity at Visit 4 (Day 15) in the Subgroup of Participants With More Severe Ocular Discomfort | 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, in a sub-group of participants with more severe ocular discomfort at baseline. | 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) and to Visit 4 (Day 15) |
|
| |||||||||||||||||||||||||||||
| Secondary | Change in Conjunctival Hyperemia Scores at Visit 4 (Day 15) in the Subgroup of Participants With More Severe Ocular Discomfort at Baseline (Day 1) | Comparison of mean bulbar conjunctival hyperemia 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. | 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) and to Visit 4 (Day 15) |
|
| |||||||||||||||||||||||||||||
| Secondary | Proportion of Subjects With ≥1 Improvement in Conjunctival Hyperemia at Visit 4 (Day 15) | Proportion of subjects with ≥1 improvement from baseline in conjunctival hyperemia scores. 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) and to Visit 4 (Day 15) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline/Visit 2 (Day 1) Conjunctival Hyperemia Scores at Visit 4 (Day 15) for the Mean of All Regions (Nasal, Temporal, Frontal) | Comparison of mean bulbar conjunctival hyperemia 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) and to Visit 4 (Day 15) |
|
| |||||||||||||||||||||||||||||
| Secondary | Change in Ocular Discomfort Severity Scores Prior to Visit 3 (Day 8) Minus the Mean of the Scores to Baseline/Visit 2 (Day 1) | 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) and to Visit 3 (Day 8) |
|
| |||||||||||||||||||||||||||||
| Secondary | Change in Ocular Discomfort Severity Scores Prior to Visit 3 (Day 8) Minus Baseline/Visit 2 (Day 1) in the Subgroup of Participants With More Severe Ocular Discomfort. | 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. | 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) and to Visit 3 (Day 8) |
|
| |||||||||||||||||||||||||||||
| Secondary | Change in Ocular Discomfort Severity Scores on Day 4 (Diary) Minus Baseline/Visit 2 (Day 1) | 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) and to Visit 3 (Day 8) |
|
| |||||||||||||||||||||||||||||
| Secondary | Change in Ocular Discomfort Severity Scores on Day 4 Day 4 (Diary) Minus Baseline/Visit 2 (Day 1) in the Subgroup of Participants With More Severe Ocular Discomfort | 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, in a sub-group of participants with more severe ocular discomfort at baseline. | 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) and to Visit 3 (Day 8) |
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline/Visit 2 (Day 1) in Conjunctival Hyperemia Scores With a Day 1 Conjunctival Hyperemia Score of ≥ 2 in the Subgroup of Participants With More Severe Ocular Discomfort | Comparison of mean bulbar conjunctival hyperemia between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-4 grading scale in a sub-group of participants with more severe ocular discomfort at baseline.. 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. | 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) and to Visit 4 (Day 15) |
|
| |||||||||||||||||||||||||||||
| Secondary | Subjects With a Grade of 0 in Conjunctival Hyperemia Score at Visit 4 (Day 15) | Comparison of mean bulbar conjunctival hyperemia 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 | Count of Participants | Participants | Visit 4 (Day 15) |
|
|
Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
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| 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 | 459 | 0 | 459 | 66 | 459 |
| EG001 | Vehicle of KPI-121 0.25% Ophthalmic Suspension | Participants randomized to Vehicle of KPI-121 0.25% Ophthalmic Suspension | 0 | 456 | 0 | 456 | 62 | 456 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye Irritation | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Blepharitis | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Lacrimination increased | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Conjunctival hyperemia | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Eye Pain | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Foreign Body Sensation | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Conjunctival vascular disorder | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Eye discharge | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Eye Pruritus | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Eyelid margin crusting | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Eyelid ptosis | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Trichiasis | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Vision Blurred | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Vitreous detachment | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Blepharospasm | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Keratitis | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Ocular hyperaemia | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Photophobia | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Punctate keratitis | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| hypoaesthesia oral | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Installation site pain | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Instillation site foreign body sensation | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Instillation site lacrimation | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Instillation site pruritus | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Installation site discomfort | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Installation site reaction | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pneumonia | 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 |
| |
| Bronchitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| Ligament Sprain | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| Intraocular pressure increased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Spinal Column Stenosis | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Nerve Compression | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Sinus Headache | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Dermatitis Contact | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Eccymosis | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
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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 | Results006@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
| Male |
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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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| Participants |
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