Safety and Efficacy of KPI-121 in Subjects With Dry Eye Disease (Kauai)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02188160 |
Recruitment Status :
Completed
First Posted : July 11, 2014
Results First Posted : January 6, 2021
Last Update Posted : January 6, 2021
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Dry Eye Syndromes Keratoconjunctivitis Sicca | Drug: KPI-121 Drug: Placebo | Phase 2 |
This is a Phase II, 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.
Approximately 400 subjects will be screened and up to 150 subjects will be randomized at up to 12 centers located in the United States. Subjects will be randomized to 1 of 2 study arms in an approximate 1:1 ratio. The study arms are: 1) KPI-121 0.25% ophthalmic suspension administered 1-2 drops in each eye QID for up to 28 days or 2) vehicle administered as 1-2 drops in each eye QID for up to 28 days.
This study will include up to 6 clinic visits over 6 weeks. At Visit 1 Screening (14 ± 1 days prior to Day 1), subjects who meet screening inclusion/exclusion criteria will begin a 2-week run-in period during which they will be treated with 1-2 drops of single-masked vehicle in each eye QID for 14 ± 1 days.
At Visit 2, Randomization (Day 1), subjects who continue to meet inclusion/exclusion criteria will be eligible for randomization to 1 of the 2 arms of the study (i.e., KPI-121 0.25% ophthalmic suspension or vehicle). Following randomization, subjects will be instructed to return to the clinic to have a complete study evaluation at Study Visits 4 and 6 (Days 15 ± 1 day and 29 ± 1 day, respectively). Subjects will further be instructed to return to the clinic for diary collection and in-clinic symptom assessment only at Visits 3 and 5 (Days 8 ± 1 day and 22 ± 1 day, respectively). The last dose of investigational product and the final study visit will occur upon completion of 28 ± 1 days of exposure to investigational product. Subjects will be released from the study at the end of Visit 6 (Day 29 ± 1 day).
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 150 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official 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 |
Study Start Date : | June 2014 |
Actual Primary Completion Date : | January 2015 |
Actual Study Completion Date : | March 2015 |

Arm | Intervention/treatment |
---|---|
Active Comparator: KPI-121 0.25% Ophthalmic Suspension
KPI-121 0.25% ophthalmic suspension dosed QID for 28 days in subjects with dry eye disease
|
Drug: KPI-121
KPI-121 drug product will be supplied as 0.25% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.
Other Names:
|
Placebo Comparator: Vehicle
Vehicle (placebo) dosed QID for 28 days in subjects with dry eye disease
|
Drug: Placebo
Subjects randomized to placebo control arms will receive the same bottles containing all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate.
Other Name: Vehicle of KPI-121 0.25% Ophthalmic Suspension |
- Bulbar Conjunctival Hyperemia [ Time Frame: Visit 6 (Day 29) ]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.
- Ocular Discomfort [ Time Frame: Visit 6 (Day 29) ]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.
- Corneal Fluorescein Staining Scores [ Time Frame: Visit 4 (Day 15) and Visit 6 (Day 29) ]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.
- Bulbar Conjunctival Hyperemia Scores [ Time Frame: Visit 4 (Day 15) ]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.
- Ocular Discomfort [ Time Frame: 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02188160
United States, California | |
Sall Research Medical Center | |
Artesia, California, United States, 90701 | |
North Valley Eye Medical Group | |
Mission Hills, California, United States, 91345 | |
Martel Eye Medical Group | |
Rancho Cordova, California, United States, 95670 | |
United States, Connecticut | |
Eye Center of Southern CT, P.C. | |
Hamden, Connecticut, United States, 06518 | |
United States, Indiana | |
Price Vision Group | |
Indianapolis, Indiana, United States, 46260 | |
United States, Missouri | |
Ophthalmology Associates | |
Saint Louis, Missouri, United States, 63131 | |
Comprehensive Eye Care, Ltd. / Vision Research Institute, LLC | |
Washington, Missouri, United States, 63090 | |
United States, New York | |
South Shore Eye Center, LLP | |
Wantagh, New York, United States, 11793 | |
United States, Ohio | |
Abrams Eye Center | |
Cleveland, Ohio, United States, 44115 | |
United States, Tennessee | |
Total Eye Care, PA | |
Memphis, Tennessee, United States, 38119 | |
United States, Texas | |
Whitsett Vision Group | |
Houston, Texas, United States, 77055 |
Principal Investigator: | Gregg Berdy, MD | Ophthalmology Associates | |
Principal Investigator: | David Evans, OD | Total Eye Care, PA | |
Principal Investigator: | Kathy Kelley, OD | Price Vision Group | |
Principal Investigator: | Joseph Martel, MD | Martel Eye Medical Group | |
Principal Investigator: | Mark Milner, MD | Eye Center of Southern CT, P.C. | |
Principal Investigator: | Steven Rauchman, MD | North Valley Eye Medical Group | |
Principal Investigator: | Kenneth Sall, MD | Sall Research Medical Center | |
Principal Investigator: | Jeffrey Whitsett, MD | Whitsett Vision Group | |
Principal Investigator: | Marc Abrams, MD | Abrams Eye Center | |
Principal Investigator: | Michael Korenfeld, MD | Ecomprehensive Eye Care, Ltd / Vision Research Institute LLC | |
Principal Investigator: | Jodi Luchs, MD | South Shore Eye Center |
Documents provided by Kala Pharmaceuticals, Inc.:
Responsible Party: | Kala Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT02188160 |
Other Study ID Numbers: |
KPI-121-C-002 |
First Posted: | July 11, 2014 Key Record Dates |
Results First Posted: | January 6, 2021 |
Last Update Posted: | January 6, 2021 |
Last Verified: | July 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Pain Corticosteroid Dry Eye Hyperemia Ocular Discomfort |
Keratoconjunctivitis Sicca Dry Eye Syndromes Eye Diseases Keratoconjunctivitis Conjunctivitis Conjunctival Diseases |
Keratitis Corneal Diseases Lacrimal Apparatus Diseases Loteprednol Etabonate Anti-Allergic Agents |