A Study to Confirm the Efficacy and Safety of K-161 Ophthalmic Solution for Treatment of Moderate to Severe Dry Eye Disease
Public ClinicalTrials.gov record NCT05403827. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Prospective, Double-masked, Randomized, Multi-center, Vehicle-controlled, Parallel-group, 12-week Administration and 40-week Extension Study Confirming the Efficacy and Safety of K-161 Ophthalmic Solution for the Treatment of Moderate to Severe Dry Eye Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to assess the efficacy and safety of K-161 ophthalmic solution for the treatment of moderate to severe dry eye disease.
Study identification
- NCT ID
- NCT05403827
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 644 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 2, 2022
- Primary completion
- Aug 24, 2023
- Completion
- Dec 4, 2023
- Last update posted
- Jan 13, 2025
2022 – 2023
United States locations
- U.S. sites
- 51
- U.S. states
- 19
- U.S. cities
- 48
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The University of Alabama at Birmingham School of Optometry, Clinical Eye Research Center | Birmingham | Alabama | 35294 | — |
| Trinity Research Group | Dothan | Alabama | 36301 | — |
| Cornea and Cataract Consultants of Arizona | Phoenix | Arizona | 85032 | — |
| Citrus Valley Eyecare / Premiere Practice Management, LLC | Covina | California | 91723 | — |
| Orange County Ophthalmology Medical Group | Garden Grove | California | 92843 | — |
| Global Research Management | Glendale | California | 91204 | — |
| Inland Eye Specialists | Hemet | California | 92545 | — |
| United Medical Research Institute | Inglewood | California | 90301 | — |
| Premiere Practice Management, LLC | Los Angeles | California | 90013 | — |
| North Valley Eye Medical Group, Inc | Mission Hills | California | 91345 | — |
| LoBue Laser and Eye Medical Center | Murrieta | California | 92562 | — |
| Eye Research Foundation, Inc. | Newport Beach | California | 92663 | — |
| Pendleton Eye Center | Oceanside | California | 92056 | — |
| Martel Eye Medical Group | Rancho Cordova | California | 95670 | — |
| Sierra Clinical Trial Research Organization | Santa Ana | California | 92705 | — |
| Premiere Practice Management, LLC | Torrance | California | 90505 | — |
| Wolstan and Goldberg Eye Associates | Torrance | California | 90505 | — |
| Vision Institute | Colorado Springs | Colorado | 80907 | — |
| Corneal Consultants of Colorado dba Colorado Eye Consultants | Littleton | Colorado | 80120 | — |
| Segal Drug Trials | Delray Beach | Florida | 33484 | — |
| Bowden Eye & Associates | Jacksonville | Florida | 32256 | — |
| Shettle Eye Research, Inc. | Largo | Florida | 33773 | — |
| International Research Center | Tampa | Florida | 33603 | — |
| Dixophthal, PC. | Albany | Georgia | 31701 | — |
| Edwin Yoshio Endo, OD & Associates & Interns | ‘Aiea | Hawaii | 96701 | — |
| Chicago Cornea Consultants | Hoffman Estates | Illinois | 60169 | — |
| Jones Eye Clinic and Surgery Center | Sioux City | Iowa | 51104 | — |
| Seidenberg Protzko Eye Associates | Havre de Grace | Maryland | 21078 | — |
| Midwest Vision Research Foundation at Pepose Vision Institute | Chesterfield | Missouri | 63017 | — |
| Tauber Eye Center | Kansas City | Missouri | 64111 | — |
| Tekwani Vision Center | St Louis | Missouri | 63128 | — |
| Ophthalmology Associates | St Louis | Missouri | 63131 | — |
| Comprehensive Eye Care, Ltd. | Washington | Missouri | 63090 | — |
| Wellish Vision Institute | Las Vegas | Nevada | 89119 | — |
| Asheville Eye Associates | Asheville | North Carolina | 28803 | — |
| Oculus Research | Garner | North Carolina | 27529 | — |
| Wake Forest Health Network, LLC | High Point | North Carolina | 27262 | — |
| Insight Research Clinic, LLC dba EyeCare Professionals | Powell | Ohio | 43065 | — |
| Conestoga Eye PC | Lancaster | Pennsylvania | 17601 | — |
| Associates in Ophthalmology Ltd | West Mifflin | Pennsylvania | 15122 | — |
| West Bay Eye Associates | Warwick | Rhode Island | 02888 | — |
| Total Eye Care, PA | Memphis | Tennessee | 38119 | — |
| Advancing Vision Research | Smyrna | Tennessee | 37167 | — |
| Keystone Research | Austin | Texas | 78731 | — |
| Hill Country Eye Center | Cedar Park | Texas | 78613 | — |
| Southwest Eye Institute | El Paso | Texas | 79902 | — |
| Lake Travis Eye and Laser Center/Revolution Research | Lakeway | Texas | 78738 | — |
| R and R Eye Research, LLC | San Antonio | Texas | 78229 | — |
| DCT-Shah Research, LLC dba Discovery Clinical Trials | San Antonio | Texas | 78230 | — |
| Northern Virginia Ophthalmology Associates | Falls Church | Virginia | 22042 | — |
| Virginia Eye Consultants, Inc. | Norfolk | Virginia | 23502 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05403827, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 13, 2025 · Synced Sep 28, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05403827 live on ClinicalTrials.gov.