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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 Ophthalmic Suspension | Drug | KPI-121 Ophthalmic Suspension |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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) 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 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigator #133 | Birmingham | Alabama | 35294 | United States | ||
| Investigator #278 |
901 subjects were randomized and all were included in the ITT population.
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| ID | Title | Description |
|---|---|---|
| FG000 | KPI-121 0.25% Ophthalmic Suspension | KPI-121 Ophthalmic Suspension: KPI-121 Ophthalmic Suspension |
| FG001 | Vehicle of KPI-121 0.25% Ophthalmic Suspension | Vehicle: Vehicle for 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 | Mar 27, 2019 |
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| Vehicle |
| Drug |
Vehicle for KPI-121 0.25% ophthalmic suspension |
|
| Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15) |
| Change in Conjunctival Hyperemia Scores at Visit 4 (Day 15) by Alternate Assessor | 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 3 (Day 8) | 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) to Visit 3 (Day 8) |
| 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) to Visit 4 (Day 15) |
| Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity at Visit 4 (Day 15) Using 7 Day Mean | 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) to Visit 4 (Day 15) |
| Dothan |
| Alabama |
| 36301 |
| United States |
| Investigator #146 | Chandler | Arizona | 85224 | United States |
| Investigator #148 | Phoenix | Arizona | 85032 | United States |
| Investigator #280 | Prescott | Arizona | 86301 | United States |
| Investigator #276 | Sun City | Arizona | 85351 | United States |
| Investigator #185 | Azusa | California | 91702 | United States |
| Investigator #143 | Garden Grove | California | 92843 | United States |
| Investigator #147 | Glendale | California | 91204 | United States |
| Investigator #272 | Hemet | California | 92545 | United States |
| Investigator #155 | Inglewood | California | 90301 | United States |
| Investigator #273 | Long Beach | California | 90805 | United States |
| Investigator #130 | Mission Hills | California | 91345 | United States |
| Investigator #247 | Murrieta | California | 92562 | United States |
| Investigator #215 | Newport Beach | California | 92663 | United States |
| Site #111 | Rancho Cordova | California | 95670 | United States |
| Investigator #271 | Santa Ana | California | 92705 | United States |
| Investigator #107 | Torrance | California | 90505 | United States |
| Investigator #213 | Westminster | California | 92683 | United States |
| Investigator #218 | Littleton | Colorado | 80120 | United States |
| Investigator #184 | Brooksville | Florida | 34613 | United States |
| Investigator #262 | Delray Beach | Florida | 33484 | United States |
| Investigator #279 | Fort Myers | Florida | 33901 | United States |
| Investigator #265 | Jacksonville | Florida | 32256 | United States |
| Investigator #157 | Largo | Florida | 33773 | United States |
| Investigator #189 | Tampa | Florida | 33603 | United States |
| Investigator #136 | Morrow | Georgia | 30260 | United States |
| Investigator #268 | Roswell | Georgia | 30076 | United States |
| Investigator #266 | Chicago | Illinois | 60616 | United States |
| Investigator #187 | Hoffman Estates | Illinois | 60169 | United States |
| Investigator #151 | Lake Villa | Illinois | 60046 | United States |
| Investigator #128 | Indianapolis | Indiana | 46260 | United States |
| Investigator #250 | Indianapolis | Indiana | 46290 | United States |
| Investigator #125 | New Albany | Indiana | 47150 | United States |
| Investigator #274 | Lexington | Kentucky | 40517 | United States |
| Investigator #195 | Louisville | Kentucky | 40206 | United States |
| Investigator #168 | Louisville | Kentucky | 40220 | United States |
| Investigator #219 | Winchester | Massachusetts | 01890 | United States |
| Investigator #267 | Kansas City | Missouri | 64133 | United States |
| Investigator #123 | St Louis | Missouri | 63128 | United States |
| Investigator #106 | St Louis | Missouri | 63131 | United States |
| Investigator #126 | St Louis | Missouri | 63131 | United States |
| Investigator #131 | Washington | Missouri | 63090 | United States |
| Investigator #281 | Henderson | Nevada | 89052 | United States |
| Investigator #275 | Las Vegas | Nevada | 89123 | United States |
| Investigator #263 | Las Vegas | Nevada | 89145 | United States |
| Investigator #138 | Las Vegas | Nevada | 89148 | United States |
| Investigator #105 | New York | New York | 10013 | United States |
| Investigator #108 | Rochester | New York | 14618 | United States |
| Investigator #132 | Wantagh | New York | 11793 | United States |
| Investigator #264 | Asheville | North Carolina | 28803 | United States |
| Investigator #217 | Durham | North Carolina | 27704 | United States |
| Investigator #149 | Durham | North Carolina | 27710 | United States |
| Investigator #102 | High Point | North Carolina | 27262 | United States |
| Investigator #163 | Raleigh | North Carolina | 27603 | United States |
| Investigator #282 | Southern Pines | North Carolina | 28387 | United States |
| Investigator #269 | Cincinnati | Ohio | 45242 | United States |
| Investigator #142 | Cincinnati | Ohio | 45247 | United States |
| Investigator #137 | Cleveland | Ohio | 44115 | United States |
| Investigator #171 | Mason | Ohio | 45040 | United States |
| Investigator #224 | Cranberry Township | Pennsylvania | 16066 | United States |
| Investigator #156 | Kingston | Pennsylvania | 18704 | United States |
| Investigator #200 | Lancaster | Pennsylvania | 17601 | United States |
| Investigator #277 | West Mifflin | Pennsylvania | 15122 | United States |
| Investigator #240 | Rapid City | South Dakota | 57701 | United States |
| Investigator #127 | Memphis | Tennessee | 38119 | United States |
| Investigator #270 | Austin | Texas | 78681 | United States |
| Investigator #188 | Austin | Texas | 78731 | United States |
| Investigator #174 | Cedar Park | Texas | 78613 | United States |
| Investigator #140 | El Paso | Texas | 79902 | United States |
| Investigator #124 | Houston | Texas | 77055 | United States |
| Investigator #259 | Houston | Texas | 77204 | United States |
| Investigator #175 | Lakeway | Texas | 78734 | United States |
| Investigator #182 | League City | Texas | 77573 | United States |
| Investigator #191 | League City | Texas | 77573 | United States |
| Site #177 | San Antonio | Texas | 78209 | United States |
| Investigator #258 | San Antonio | Texas | 78229 | United States |
| Investigator #186 | San Antonio | Texas | 78230 | United States |
| Investigator #176 | San Antonio | Texas | 78240 | United States |
| Investigator #222 | Layton | Utah | 84041 | United States |
| Investigator #119 | Norfolk | Virginia | 23502 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | KPI-121 0.25% Ophthalmic Suspension | KPI-121 Ophthalmic Suspension: KPI-121 Ophthalmic Suspension |
| BG001 | Vehicle of KPI-121 0.25% Ophthalmic Suspension | Vehicle: Vehicle for 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 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) 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 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) |
|
| |||||||||||||||||||||||||||||
| Secondary | Change in Conjunctival Hyperemia Scores at Visit 4 (Day 15) by Alternate Assessor | 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 From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity at Visit 3 (Day 8) | 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 | Median | Standard Deviation | score on a scale | Baseline/Visit 2 (Day 1) to Visit 3 (Day 8) |
|
| |||||||||||||||||||||||||||||
| Secondary | 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) to Visit 4 (Day 15) |
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity at Visit 4 (Day 15) Using 7 Day Mean | 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) to Visit 4 (Day 15) |
|
|
Adverse events were collected at Visit 2 (Day 1) until they exited the study at Visit 4 (Day 15).
Subjects reported in each treatment arm come from the safety population and represent different numbers of subjects than that reported for efficacy (the ITT population). Two subjects Two subjects were randomized to vehicle (and were included in the vehicle arm for efficacy analyses as part of the ITT population) but erroneously received KPI-121 (and are therefore included in the KPI-121 treatment arm for safety analyses).
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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 | KPI-121 Ophthalmic Suspension: KPI-121 Ophthalmic Suspension | 0 | 449 | 3 | 449 | 39 | 449 |
| EG001 | Vehicle of KPI-121 0.25% Ophthalmic Suspension | Vehicle: Vehicle for KPI-121 0.25% ophthalmic suspension | 0 | 452 | 1 | 452 | 26 | 452 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrioventricular Block | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| Eyelid injury | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| Delusional disorder, unspecified type | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Schizoaffective disorder | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye irritation | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Instillation site pain | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Eye pruritus | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Instillation site discharge | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Instillation site pruritus | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Corneal infiltrates | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Foreign body sensation in eyes | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| keratitis | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Ocular hypaeremia | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Photophobia | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Scleral hyperaemia | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Blepharitis | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Blepharospasm | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Conjunctival heamorrhage | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Conjunctival vascular disorder | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Conjunctivitis allergic | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Eye discharge | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Eyelid pain | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Eyelids pruritus | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Growth of eyelashes | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Ocular discomfort | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Trichiasis | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Vitreous floaters | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Sinus headache | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Ligament sprain | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Vertigo | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue 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 | Results011@kalarx.com |
| Feb 9, 2021 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
|
|