A Study to Confirm the Efficacy and Safety of K-161 Ophthalmic Solution for Treatment of Moderate to Severe Dry Eye Disease

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Kowa Research Institute, Inc.
Study ID
NCT05403827
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • K-161 — DRUG
    K-161 Ophthalmic Solution
  • Placebo — DRUG
    Vehicle Solution

Study Details

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.

Key Dates

First listed
Jun 3, 2022
Start date
Jul 3, 2022
Status verified
Jan 2025
Primary completion
Aug 25, 2023
Completion
Dec 5, 2023

Study Design

Enrollment
644 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: K-161
    K-161 Ophthalmic Solution
  • Placebo Comparator: Placebo
    Vehicle Solution

Primary Outcome Measure

Change in EDS (VAS) From Baseline to Day 85 [ Time Frame: Baseline to Day 85 ]

Locations (51)

FacilityCityStateZIPSite coordinators
The University of Alabama at Birmingham School of Optometry, Clinical Eye Research CenterBirminghamAlabama35294-
Trinity Research GroupDothanAlabama36301-
Cornea and Cataract Consultants of ArizonaPhoenixArizona85032-
Citrus Valley Eyecare / Premiere Practice Management, LLCCovinaCalifornia91723-
Orange County Ophthalmology Medical GroupGarden GroveCalifornia92843-
Global Research ManagementGlendaleCalifornia91204-
Inland Eye SpecialistsHemetCalifornia92545-
United Medical Research InstituteInglewoodCalifornia90301-
Premiere Practice Management, LLCLos AngelesCalifornia90013-
North Valley Eye Medical Group, IncMission HillsCalifornia91345-
LoBue Laser and Eye Medical CenterMurrietaCalifornia92562-
Eye Research Foundation, Inc.Newport BeachCalifornia92663-
Pendleton Eye CenterOceansideCalifornia92056-
Martel Eye Medical GroupRancho CordovaCalifornia95670-
Sierra Clinical Trial Research OrganizationSanta AnaCalifornia92705-
Premiere Practice Management, LLCTorranceCalifornia90505-
Wolstan and Goldberg Eye AssociatesTorranceCalifornia90505-
Vision InstituteColorado SpringsColorado80907-
Corneal Consultants of Colorado dba Colorado Eye ConsultantsLittletonColorado80120-
Segal Drug TrialsDelray BeachFlorida33484-
Bowden Eye & AssociatesJacksonvilleFlorida32256-
Shettle Eye Research, Inc.LargoFlorida33773-
International Research CenterTampaFlorida33603-
Dixophthal, PC.AlbanyGeorgia31701-
Edwin Yoshio Endo, OD & Associates & Interns‘AieaHawaii96701-
Chicago Cornea ConsultantsHoffman EstatesIllinois60169-
Jones Eye Clinic and Surgery CenterSioux CityIowa51104-
Seidenberg Protzko Eye AssociatesHavre de GraceMaryland21078-
Midwest Vision Research Foundation at Pepose Vision InstituteChesterfieldMissouri63017-
Tauber Eye CenterKansas CityMissouri64111-
Ophthalmology AssociatesSt LouisMissouri63131-
Tekwani Vision CenterSt LouisMissouri63128-
Comprehensive Eye Care, Ltd.WashingtonMissouri63090-
Wellish Vision InstituteLas VegasNevada89119-
Asheville Eye AssociatesAshevilleNorth Carolina28803-
Oculus ResearchGarnerNorth Carolina27529-
Wake Forest Health Network, LLCHigh PointNorth Carolina27262-
Insight Research Clinic, LLC dba EyeCare ProfessionalsPowellOhio43065-
Conestoga Eye PCLancasterPennsylvania17601-
Associates in Ophthalmology LtdWest MifflinPennsylvania15122-
West Bay Eye AssociatesWarwickRhode Island02888-
Total Eye Care, PAMemphisTennessee38119-
Advancing Vision ResearchSmyrnaTennessee37167-
Keystone ResearchAustinTexas78731-
Hill Country Eye CenterCedar ParkTexas78613-
Southwest Eye InstituteEl PasoTexas79902-
Lake Travis Eye and Laser Center/Revolution ResearchLakewayTexas78738-
DCT-Shah Research, LLC dba Discovery Clinical TrialsSan AntonioTexas78230-
R and R Eye Research, LLCSan AntonioTexas78229-
Northern Virginia Ophthalmology AssociatesFalls ChurchVirginia22042-
Virginia Eye Consultants, Inc.NorfolkVirginia23502-

Find similar trials in Birmingham, AL

By research site
The University of Alabama at Birmingham School of Optometry, Clinical Eye Research Center· Birmingham, ALTrinity Research Group· Dothan, ALCornea and Cataract Consultants of Arizona· Phoenix, AZCitrus Valley Eyecare / Premiere Practice Management, LLC· Covina, CAOrange County Ophthalmology Medical Group· Garden Grove, CAGlobal Research Management· Glendale, CA

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