Dry Eye Syndromes Clinical Trial
— STRIDE 2Official title:
A Phase 3, Double-Masked, Randomized, Controlled Study of KPI-121 0.25% Ophthalmic Suspension Compared to Vehicle in Subjects With Dry Eye Disease
Verified date | November 2020 |
Source | Kala Pharmaceuticals, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 909 |
Est. completion date | September 2017 |
Est. primary completion date | September 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Have a documented clinical diagnosis of dry eye disease in both eyes Exclusion Criteria: - Known hypersensitivity or contraindication to the investigational product(s) or components - History of glaucoma, 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; or have been exposed to an investigational drug within 30 days prior to screening. - In the opinion of the 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 | Milton M. Hom, OD, FAAO | Azusa | California |
United States | UAB School of Optometry | Birmingham | Alabama |
United States | Minnesota Eye Consultants, PA | Bloomington | Minnesota |
United States | Ophthalmic Consultants of Boston | Boston | Massachusetts |
United States | Hernando Eye Institute | Brooksville | Florida |
United States | Family Eye Care Center | Campbell | California |
United States | Arizona Eye Center | Chandler | Arizona |
United States | Chattanooga Eye Institute, P.C. | Chattanooga | Tennessee |
United States | Scott & Christie and Associates, PC | Cranberry Township | Pennsylvania |
United States | Hoopes Vision | Draper | Utah |
United States | Cincinnati Eye Institute | Edgewood | Kentucky |
United States | The Cataract and Glaucoma Center | El Paso | Texas |
United States | Drs. Fine, Hoffman & Sims, LLC | Eugene | Oregon |
United States | Orange County Ophthalmology | Garden Grove | California |
United States | Lugene Eye Institute | Glendale | California |
United States | Cornerstone Eye Care | High Point | North Carolina |
United States | Chicago Cornea Consultants, Ltd. | Hoffman Estates | Illinois |
United States | Advanced Laser Vision & Surgical Institute, Intouch Clinical Research Center | Houston | Texas |
United States | Houston Eye Associates | Houston | Texas |
United States | The Ocular Surface Institute (TOSI), University of Houston | Houston | Texas |
United States | Whitsett Vision Group | Houston | Texas |
United States | Price Vision Group | Indianapolis | Indiana |
United States | The Gavin Herbert Eye Institute | Irvine | California |
United States | NEA Baptist Clinic | Jonesboro | Arkansas |
United States | Tauber Eye Center | Kansas City | Missouri |
United States | Eye Care Specialists | Kingston | Pennsylvania |
United States | Brazosport Eye Institute | Lake Jackson | Texas |
United States | Central Florida Eye Associates | Lakeland | Florida |
United States | Shettle Eye Research, Inc | Largo | Florida |
United States | Abrams Eye Institute | Las Vegas | Nevada |
United States | Koffler Vision Group | Lexington | Kentucky |
United States | Advanced Vision Care | Los Angeles | California |
United States | Macy Eye Center | Los Angeles | California |
United States | Taustine Eye Center | Louisville | Kentucky |
United States | The Eye Care Institute | Louisville | Kentucky |
United States | Total Eye Care, PA | Memphis | Tennessee |
United States | North Valley Eye Medical Group | Mission Hills | California |
United States | Regional Eye Associates | Morgantown | West Virginia |
United States | Eye Care Centers Management, Inc. (Clayton Eye Center) | Morrow | Georgia |
United States | Toyos Clinic | Nashville | Tennessee |
United States | John-Kenyon American Eye Institute | New Albany | Indiana |
United States | Raymond Fong, MDPC | New York | New York |
United States | Eye Research Foundation | Newport Beach | California |
United States | Virginia Eye Consultants | Norfolk | Virginia |
United States | International Eye Associates PA | Ormond Beach | Florida |
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 | Ophthalmic Consultants of Long Island | Rockville Centre | New York |
United States | Tekwani Vision Center | Saint Louis | Missouri |
United States | Kozlovsky Delay & Winter Eye Consultants, LLC | San Antonio | Texas |
United States | West Coast Eye Care Associates | San Diego | California |
United States | Spokane Eye Clinical Research | Spokane | Washington |
United States | Perez Eye Center/International Research Center | Tampa | Florida |
United States | Wolstan & Goldberg Eye Associates | Torrance | California |
United States | Comprehensive Eye Care, Ltd. / Vision Research Institute, LLC | Washington | Missouri |
United States | Comprehensive Eye Care of Central Ohio | Westerville | Ohio |
United States | Michael K Tran, M.D., Inc. | Westminster | California |
United States | Bucci Laser Vision Institute | Wilkes-Barre | Pennsylvania |
United States | James D Branch MD | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Kala Pharmaceuticals, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline/Visit 2 (Day 1) - Visit 4 (Day 15) |
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