Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KPI-121 1.0% Ophthalmic Suspension | Active Comparator | dosed BID |
|
| Vehicle of KPI-121 Ophthalmic Suspension | Placebo Comparator | dosed BID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KPI-121 1% Ophthalmic Suspension dosed BID | Drug |
|
| |
| 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
| 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
| Visit 5 (Day 8) maintained through Visit 6 (Day 15) |
| 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
|
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Eye Center | Chandler | Arizona | 85225 | United States | ||
| Cornea and Cataract Consultants of CA |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | KPI-121 1.0% Ophthalmic Suspension | dosed BID KPI-121 1% Ophthalmic Suspension dosed BID |
| FG001 | Vehicle of KPI-121 Ophthalmic Suspension | dosed BID Vehicle of KPI-121 Ophthalmic Suspension dosed BID |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| 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 | Feb 24, 2017 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Vehicle of KPI-121 Ophthalmic Suspension dosed BID |
| Drug |
|
|
| 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
| 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
| Visit 1 (Baseline) and Visit 4 (Day 4) |
| Phoenix |
| Arizona |
| 85032 |
| United States |
| Sall Research Medical Center | Artesia | California | 90701 | United States |
| Orange County Ophthalmology | Garden Grove | California | 92843 | United States |
| Lugene Eye Institute | Glendale | California | 91204 | United States |
| Inland Eye Specialists | Hemet | California | 92545 | United States |
| United Medical Research Institute | Inglewood | California | 90301 | United States |
| LoBue Laser and Eye Medical Center | Murrieta | California | 92562 | United States |
| Pendleton Eye Center | Oceanside | California | 92056 | United States |
| North Bay Eye Associates, Inc. | Petaluma | California | 94954 | 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 |
| Eye Center of Northern Colorado, PC | Fort Collins | Colorado | 80525 | United States |
| Eye Associates of Fort Myers | Fort Myers | Florida | 33901 | United States |
| Levenson Eye Associates | Jacksonville | Florida | 32204 | United States |
| Shettle Eye Research, Inc | Largo | Florida | 33773 | United States |
| International Research Center | Tampa | Florida | 33603 | United States |
| Chicago Cornea Consultants, Ltd. | Hoffman Estates | Illinois | 60169 | United States |
| Jacksoneye, S. C. | Lake Villa | Illinois | 60046 | United States |
| The Eye Care Institute | Louisville | Kentucky | 40206 | United States |
| Great Lakes Eye Care | Saint Joseph | Michigan | 49085 | United States |
| Minnesota Eye Consultants, PA | Bloomington | Minnesota | 55431 | United States |
| Comprehensive Eye Care, Ltd. / Vision Research Institute, LLC | Washington | Missouri | 63090 | United States |
| Abrams Eye Institute | Las Vegas | Nevada | 89148 | United States |
| Duke University Eye Center | Durham | North Carolina | 27703 | United States |
| Apex Eye | Cincinnati | Ohio | 45247 | United States |
| Roseburg Research Associates, LLC | Roseburg | Oregon | 97471 | United States |
| Eye Care Specialists | Kingston | Pennsylvania | 18704 | United States |
| Carolina Cataract & Laser Center | Ladson | South Carolina | 29456 | United States |
| Carolina Eyecare Physicians, LLC | Mt. Pleasant | South Carolina | 29464 | United States |
| Texan Eye, PA / Keystone Research, Ltd | Austin | Texas | 78731 | United States |
| The Cataract & Glaucoma Center | El Paso | Texas | 79902 | United States |
| Houston Eye Associates | Houston | Texas | 77024 | United States |
| Kozlovsky Delay & Winter Eye Consultants, LLC Corona Research | San Antonio | Texas | 78213 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | KPI-121 1.0% Ophthalmic Suspension | dosed BID KPI-121 1% Ophthalmic Suspension dosed BID |
| BG001 | Vehicle of KPI-121 Ophthalmic Suspension | dosed BID Vehicle of KPI-121 Ophthalmic Suspension dosed BID |
| 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 | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | 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 | 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
| Intent to Treat - All subjects randomized | Posted | Count of Participants | Participants | Visit 5 (Day 8) maintained through Visit 6 (Day 15) |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | 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
| Intent to Treat - All subjects randomized | Posted | Count of Participants | Participants | Visit 5 (Day 8) maintained through Visit 6 (Day 15) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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
| Intent to Treat - All subjects randomized | Posted | Count of Participants | Participants | Visit 4 (Day 4) maintained through Visit 6 (Day 15) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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
| Intent to Treat - All subjects randomized | Posted | Count of Participants | Participants | Visit 4 (Day 4) maintained through Visit 6 (Day 15) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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
| Intent to Treat - All subjects randomized | Posted | Mean | Standard Deviation | score on a scale | Visit 1 (Baseline) and Visit 4 (Day 4) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Post-Hoc | Change From Baseline (BL) Anterior Chamber (AC) Cells at Day 8 | The difference in mean changes from BL in AC cell count grade at Day 8 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
| Intent to Treat - All subjects randomized | Posted | Mean | Standard Deviation | score on a scale | Visit 1 (Baseline) and Visit 5 (Day 8) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Post-Hoc | Change From Baseline (BL) Anterior Chamber (AC) Cells at Day 15 | The difference in mean changes from BL in AC cell count grade at 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
| Intent to Treat - All subjects randomized | Posted | Mean | Standard Deviation | score on a scale | Visit 1 (Baseline) and Visit 6 (Day 15) |
|
|
Adverse events were collected from the time a subjects signed the informed consent until they exited the study at the end of Visit 7 (up to 18 days).
Not provided
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 1% Ophthalmic Suspension | KPI-121 1% Ophthalmic Suspension dosed BID | 0 | 261 | 1 | 261 | 18 | 261 |
| EG001 | Vehicle of KPI-121 1% Ophthalmic Suspension | Vehicle of KPI-121 1% Ophthalmic Suspension dosed BID | 0 | 259 | 2 | 259 | 21 | 259 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholecystitis | Hepatobiliary disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Hypertensive emergency | Vascular disorders | MedDRA (16.1) | Systematic Assessment |
| |
| erebrovascular Accident | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cystoid macular oedema | Eye disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Posterior capsule opacification | Eye disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Instilation site pain | General disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
|
No submission for publication or public disclosure will be made by the PI until after the publication of the results of the multi-center clinical trial by the Sponsor. Thereafter, PI shall provide KALA with an advance copy of any proposed publication or public disclosure at least sixty (60) days prior to the planned date of submission or disclosure and KALA shall have forty-five (45) days from the date of its receipt to recommend changes.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head, Clinical Operations | Kala Pharmaceuticals, Inc. | 781-996-5252 | Results005@kalarx.com |
| Nov 24, 2020 |
| Prot_SAP_002.pdf |
| ID | Term |
|---|---|
| D010146 | Pain |
| D002386 | Cataract |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D010335 | Pathologic Processes |
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 |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Superiority |
|
|
|
|
| Participants |
|
|
|
|
|
|
|
|
|