Post Surgical Ocular Inflammation and Pain Clinical Trial
Official title:
A Phase 3, Double-Masked, Randomized, Controlled Study to Evaluate the Safety and Efficacy of KPI-121 1.0% Ophthalmic Suspension in Subjects With Postsurgical Inflammation and Pain
| NCT number | NCT02793817 |
| Other study ID # | KPI-121-C-005 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 3 |
| First received | |
| Last updated | |
| Start date | June 2016 |
| Est. completion date | March 2017 |
| Verified date | October 2018 |
| Source | Kala Pharmaceuticals, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 520 |
| Est. completion date | March 2017 |
| Est. primary completion date | March 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: Candidates for routine, uncomplicated cataract surgery In Investigator's opinion, potential postoperative Snellen Distance VA by pinhole method of at least 20/200 in study eye. Exclusion Criteria: - Known hypersensitivity/contraindication to study product(s) or components. - History of glaucoma, intraocular pressure (IOP) >21 mmHg at the screening or randomization visits, or being treated for glaucoma in either eye. - Diagnosis of: ongoing ocular infection; severe/serious ocular condition that in judgment of Investigator could confound study assessments or limit compliance; severe/serious systemic disease or uncontrolled medical condition that in judgment of Investigator could confound study assessments or limit compliance; or have been exposed to an investigational drug within the 30 days prior to screening or 18 days following surgery. - In the opinion of Investigator or study coordinator, be unwilling or unable to comply with study protocol or unable to successfully instill eye drops. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Sall Research Medical Center | Artesia | California |
| United States | Texan Eye, PA / Keystone Research, Ltd | Austin | Texas |
| United States | Minnesota Eye Consultants, PA | Bloomington | Minnesota |
| United States | Arizona Eye Center | Chandler | Arizona |
| United States | Apex Eye | Cincinnati | Ohio |
| United States | Duke University Eye Center | Durham | North Carolina |
| United States | The Cataract & Glaucoma Center | El Paso | Texas |
| United States | Eye Center of Northern Colorado, PC | Fort Collins | Colorado |
| United States | Eye Associates of Fort Myers | Fort Myers | Florida |
| United States | Orange County Ophthalmology | Garden Grove | California |
| United States | Lugene Eye Institute | Glendale | California |
| United States | Inland Eye Specialists | Hemet | California |
| United States | Chicago Cornea Consultants, Ltd. | Hoffman Estates | Illinois |
| United States | Houston Eye Associates | Houston | Texas |
| United States | United Medical Research Institute | Inglewood | California |
| United States | Levenson Eye Associates | Jacksonville | Florida |
| United States | Eye Care Specialists | Kingston | Pennsylvania |
| United States | Carolina Cataract & Laser Center | Ladson | South Carolina |
| United States | Jacksoneye, S. C. | Lake Villa | Illinois |
| United States | Shettle Eye Research, Inc | Largo | Florida |
| United States | Abrams Eye Institute | Las Vegas | Nevada |
| United States | The Eye Care Institute | Louisville | Kentucky |
| United States | Carolina Eyecare Physicians, LLC | Mount Pleasant | South Carolina |
| United States | LoBue Laser and Eye Medical Center | Murrieta | California |
| United States | Pendleton Eye Center | Oceanside | California |
| United States | North Bay Eye Associates, Inc. | Petaluma | California |
| United States | Cornea and Cataract Consultants of CA | Phoenix | Arizona |
| United States | Arch Health Partners | Poway | California |
| United States | Martel Eye Medical Group | Rancho Cordova | California |
| United States | Shasta Eye Medical Group, Inc | Redding | California |
| United States | Roseburg Research Associates, LLC | Roseburg | Oregon |
| United States | Great Lakes Eye Care | Saint Joseph | Michigan |
| United States | Kozlovsky Delay & Winter Eye Consultants, LLC Corona Research | San Antonio | Texas |
| United States | International Research Center | Tampa | Florida |
| United States | Comprehensive Eye Care, Ltd. / Vision Research Institute, LLC | Washington | Missouri |
| Lead Sponsor | Collaborator |
|---|---|
| Kala Pharmaceuticals, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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 = 1 - 5 cells = 6 - 15 cells = 16 - 30 cells = greater than 30 cells |
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 = Minimal = Mild = Moderate = Moderately Severe = Severe |
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 = Minimal = Mild = Moderate = Moderately Severe = Severe |
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 = Mild (trace to clearly noticeable, visible) = Moderate (without plastic aqueous humor) = Marked (with plastic aqueous humor) = Severe (with fibrin deposits and/or clots) |
Visit 4 (Day 4) maintained through Visit 6 (Day 15) | |
| 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 = 1 - 5 cells = 6 - 15 cells = 16 - 30 cells = greater than 30 cells |
Visit 1 (Baseline) and Visit 4 (Day 4) |