Dry Eye Syndromes Clinical Trial
— KauaiOfficial title:
A Phase II, Double-Masked, Randomized, Controlled Study of KPI-121 0.25% Ophthalmic Suspension Compared to Vehicle in Subjects With Dry Eye Disease
NCT number | NCT02188160 |
Other study ID # | KPI-121-C-002 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | June 2014 |
Est. completion date | March 2015 |
Verified date | July 2019 |
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 28 days, with 1-2 drops instilled in each eye four times daily (QID).
Status | Completed |
Enrollment | 150 |
Est. completion date | March 2015 |
Est. primary completion date | January 2015 |
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/contraindication to study 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; 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. - 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 | Abrams Eye Center | Cleveland | Ohio |
United States | Eye Center of Southern CT, P.C. | Hamden | Connecticut |
United States | Whitsett Vision Group | Houston | Texas |
United States | Price Vision Group | Indianapolis | Indiana |
United States | Total Eye Care, PA | Memphis | Tennessee |
United States | North Valley Eye Medical Group | Mission Hills | California |
United States | Martel Eye Medical Group | Rancho Cordova | California |
United States | Ophthalmology Associates | Saint Louis | Missouri |
United States | South Shore Eye Center, LLP | Wantagh | New York |
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 | Bulbar Conjunctival Hyperemia | Comparison of mean 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. | Visit 6 (Day 29) | |
Primary | 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. | Visit 6 (Day 29) | |
Secondary | Corneal Fluorescein Staining Scores | Comparison of mean corneal fluorescein staining scores 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. The total score is obtained by summing each of the 5 sections of the cornea. The NEI score will be from 0-15. | Visit 4 (Day 15) and Visit 6 (Day 29) | |
Secondary | Bulbar Conjunctival Hyperemia Scores | Comparison of mean bulbar conjunctival hyperemia scores 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. | Visit 4 (Day 15) | |
Secondary | 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. | Visit 4 (Day 15) |
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