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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03004924
Other study ID # SHP640-303
Secondary ID 2016-003361-25
Status Completed
Phase Phase 3
First received
Last updated
Start date March 29, 2017
Est. completion date October 1, 2018

Study information

Verified date May 2021
Source Takeda
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine if an investigational treatment is effective compared with placebo and PVP-Iodine in the treatment of adults and children with bacterial conjunctivitis.


Recruitment information / eligibility

Status Completed
Enrollment 753
Est. completion date October 1, 2018
Est. primary completion date October 1, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - An understanding, ability, and willingness to fully comply with study procedures and restrictions (by the parent(s), guardian, or legally authorized representative, if applicable). - Ability to voluntarily provide written, signed, and dated (personally or via a parent(s), guardian, or legally authorized representative(s) informed consent (and assent, if applicable) to participate in the study. - Participants of any age at Visit 1 (Note: participants less than (<) 3 months of age at Visit 1 must have been full-term, that is (ie,) greater than or equal to (>=) 37 weeks gestational age at birth). - Have a negative AdenoPlusĀ® test in both eyes within 24 hours of Visit 1 or at Visit 1. - Have a clinical diagnosis of suspected bacterial conjunctivitis in at least 1 eye confirmed by the presence of the following minimal clinical signs and symptoms in that same eye: 1. Report presence of signs and/or symptoms of bacterial conjunctivitis for less than or equal to (<=) 4 days prior to Visit 1 2. Bulbar conjunctival injection: a grade of >= 1 on 0-4 scale of Bulbar Conjunctival Injection Scale 3. Ocular conjunctival discharge: a grade of >= 1 (mild) on a 0-3 scale of Ocular Conjunctival Discharge Scale - Be willing to discontinue contact lens wear for the duration of the study. - Have a Best Corrected Visual Acuity (BCVA) of 0.60 logMAR or better in each eye as measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. BCVA will be assessed by an age appropriate method in accordance with the AAP Policy Statement for Visual System Assessment in Infants, Children, and Young Adults by Pediatricians (Donahue and Baker, 2016; American Academy of Pediatrics, 2016). The policy statement recommends formal vision screening can begin at 3 years of age. VA measurements for children under the age of 3 will be done at the discretion of the investigator. If not done, child should be able to fixate on and follow a moving object, except participants < 2 months of age who have not yet developed this ability. Participants < 2 months will be enrolled at the discretion of investigator. - Male, or non-pregnant, non-lactating female who agrees to comply with any applicable contraceptive requirements of the protocol or females of non-childbearing potential. Exclusion Criteria: - Current or recurrent disease that could affect the action, absorption, or disposition of the investigational product, or clinical or laboratory assessments, per investigator's discretion. - Current or relevant history of physical or psychiatric illness, any medical disorder that may make the participant unlikely to fully complete the study, or any condition that presents undue risk from the investigational product or procedures. - Have known or suspected intolerance or hypersensitivity to the investigational product, closely related compounds, or any of the stated ingredients. - Prior enrollment in a FST-100 or SHP640 clinical study. - Participants who are employees, or immediate family members of employees (who are directly related to study conduct), at the investigational site. - Have a history of ocular surgical intervention within <= 6 months prior to Visit 1 or planned for the period of the study. - Have a preplanned overnight hospitalization during the period of the study. - Have presence of any intraocular, corneal, or conjunctival ocular inflammation (example [eg,] uveitis, iritis, ulcerative keratitis, chronic blepharoconjunctivitis), other than bacterial conjunctivitis. - Have active or a history of ocular herpes. - Have at enrollment or within <= 30 days of Visit 1, a clinical presentation more consistent with the diagnosis of non-infectious conjunctivitis (except presumed seasonal/perennial allergic conjunctivitis) or non-bacterial ocular infection (eg, viral, fungal, acanthamoebal, or other parasitic). Note: history or concomitant presence of presumed seasonal or perennial allergic conjunctivitis signs/symptoms is not exclusionary. - Neonates or infants (ie, participants less than 12 months of age) who have suspected or confirmed (based on the result of any test conducted prior to screening) conjunctivitis of gonococcal, chlamydial, herpetic or chemical origin. - Neonates or infants (ie, participants less than 12 months of age) whose birth mothers had any sexually transmitted disease within 1 month of delivery or any history of genital herpes. - Presence of nasolacrimal duct obstruction at Visit 1 (Day 1). - Presence of any significant ophthalmic condition (eg, Retinopathy of Prematurity, congenital cataract, congenital glaucoma) or other congenital disorder with ophthalmic involvement that could affect study variables. - Be a known intraocular pressure (IOP) steroid responder, have a known history or current diagnosis of glaucoma or be a glaucoma suspect. - Have any known clinically significant optic nerve defects. - Have a history of recurrent corneal erosion syndrome, either idiopathic or secondary to previous corneal trauma or dry eye syndrome; presence of corneal epithelial defect or any significant corneal opacity at Visit 1. - Presence of significant, active condition in the posterior segment that requires invasive treatment (eg, intravitreal treatment with vascular endothelial growth factor inhibitors or corticosteroids) and may progress during the study participation period. - Have used any topical ocular or systemic antibiotics within <= 7 days of enrollment. - Have used any topical ocular non-steroidal anti-inflammatory drugs within <= 1 day of enrollment. - Have used any topical ophthalmic steroids in the last <= 14 days. - Have used any systemic corticosteroid agents within <= 14 days of Day 1. Stable (initiated >= 30 days prior to enrollment) use of inhaled and nasal corticosteroids is allowed, given no anticipated change in dose for the duration of the study. Topical dermal steroids are allowed except in the periocular area. - Have used non-corticosteroid immunosuppressive agents within <= 14 days of Day 1. - Have used any topical ophthalmic products, including tear substitutes, and over-the-counter preparations such as lid scrubs, within 2 hours of Visit 1 and be unable to discontinue all topical ophthalmic products for the duration of the study. Use of hot or cold compresses is also not permitted during the study. - Have any significant ocular disease (eg, Sjogren's syndrome) or any uncontrolled systemic disease or debilitating disease (eg, cardiovascular disease, hypertension, sexually transmitted diseases/infections, diabetes, or cystic fibrosis) that may affect the study parameters, per investigator's discretion. - Any known history of immunodeficiency disorder or known active conditions predisposing to immunodeficiency, such as human immunodeficiency virus, hepatitis B or C, evidence of active hepatitis A (anti-hepatitis A virus immunoglobulin M), or organ or bone marrow transplantation. - Within 30 days prior to the first dose of investigational product: 1. Have used an investigational product or device, or 2. Have been enrolled in a clinical study (including vaccine studies) that, in the investigator's opinion, may impact this Shire-sponsored study.

Study Design


Intervention

Drug:
SHP640
Instill 1 drop of SHP640 (povidone-iodine [PVPI] 0.6% and Dexamethasone 0.1%) ophthalmic suspension in each eye QID (with a minimum of 2 hours between doses) for 7 days.
PVP-I 0.6%
Instill 1 drop of PVP-I 0.6% ophthalmic solution in each eye 4 times QID (with a minimum of 2 hours between doses) for 7 days.
Placebo
Instill 1 drop of placebo ophthalmic solution in each eye 4 times QID (with a minimum of 2 hours between doses) for 7 days.

Locations

Country Name City State
Australia University of the Sunshine Coast Clinical Trials Centre Sippy Downs Queensland
Austria Augenklinik, Studienzentrum, Kepler-Universitätsklinikum GmbH Linz
Austria AKH - Medizinische Universitaet Wien Vienna
Austria Vienna Institute for Research in Ocular Surgery Vienna
Canada The Ottawa Hospital - General Campus, University of Ottawa Eye Institute Ottawa Ontario
Canada University of Waterloo School of Optometry and Vision Science Waterloo Ontario
Estonia East Tallinn Central Hospital Eye Clinic Tallinn
Estonia Eye Clinic Dr Kirsta Turman (Kreutzwaldi Silmakeskus) Tallinn
Estonia Tartu University Hospital Tartu
France CHU Limoges - Hopital Dupuytren Limoges Haute Vienne
Hungary Debreceni Egyetem Debrecen
Hungary Bugat Pal Hospital Clinexpert Gyongyos Gyongyos Heves
Hungary Kaposi Mór Hospital Kaposvár
Hungary SZTE Szemeszeti Klinika Szeged Csongrad
Hungary Csolnoky Ferenc Korhaz Veszprem
Israel HaEmek Medical Center Afula
Israel Soroka University Medical Center Beer Sheva
Israel Rambam MC Haifa
Israel Sharey Zedek MC Jerusalem
Israel Rabin Medical Center-Beilinson Campus. Petah Tikva
Israel Kaplan Medical Center Rehovot
Israel Tel Aviv Medical Center Tel Aviv
Italy A.O.U. Policlinico San'Orsola-Malpighi Bologna
Poland Szpital Specjalistyczny nr 1 Bytom
Poland Centrum Medyczne Uno-Med Krakow Malopolska
Poland Centrum Diagnostyki i Mikrochirurgii Oka LENS Olsztyn
Poland Centrum Medyczne Uno-Med Tarnów
Poland Retina Sp. z o.o. Warszawa
Puerto Rico Emanuelli Research & Development Center, LLC Arecibo
Puerto Rico Centro Dotal de Investigaciones de Servicios de Salud Carolina
Puerto Rico Berrocal and Associates San Juan
South Africa Newtown Clinical Research Centre Johannesburg Gauteng
South Africa Into Research Pretoria Gauteng
South Africa Pretoria Eye Institute Pretoria Gauteng
Spain Clinica Oftalmologia Gil Piña Huelva
Spain Clinica Rementeria Madrid
Spain Instituto Oftalmológico Fernández-Vega Oviedo Asturias
Spain Cartujavision Sevilla
United States Milton M. Hom, OD, FAAO Azusa California
United States Eye Center Northeast Bangor Maine
United States Hassman Research Institute Berlin New Jersey
United States Wohl Eye Center Bloomingdale Illinois
United States Minnesota Eye Consultants, P.A Bloomington Minnesota
United States Massachusetts Eye and Ear Infirmary Boston Massachusetts
United States The Eye Associates of Manatee, LLP Bradenton Florida
United States Arizona Eye Center Chandler Arizona
United States Bluestein Custom Vision Charleston South Carolina
United States Lifelong Vision Foundation Chesterfield Missouri
United States Apex Eye Cincinnati Ohio
United States Apex Eye Kenwood Cincinnati Ohio
United States Cincinnati Eye Institute Cincinnati Ohio
United States Cleveland Eye Clinic Cleveland Ohio
United States Ericksen Research & Development, LLC Clinton Utah
United States The Columbus Eye Center Columbus Ohio
United States The Ohio State University Columbus Ohio
United States Clark S Tsai Eye Center Concord California
United States Danbury Eye Physicians and Surgeons Danbury Connecticut
United States Bruce A. Segal, MD, PA Delray Beach Florida
United States Matossian Eye Associates Doylestown Pennsylvania
United States Cincinnati Eye Institute Edgewood Kentucky
United States Eyeland Vision El Paso Texas
United States Pacific Clear Vision Institute Eugene Oregon
United States MediSphere Medical Research Center, LLC Evansville Indiana
United States NECCR PrimaCare Research Fall River Massachusetts
United States Emerson Clinical Research Institute Falls Church Virginia
United States South Florida Vision Fort Lauderdale Florida
United States Lugene Eye Institute Inc Glendale California
United States Mark B. Kislinger, MD, Inc. Glendora California
United States Lakeview Vision Gretna Louisiana
United States Inland Eye Specialists Hemet California
United States NV Eye Physicians Henderson Nevada
United States Jenkins Eye Care Honolulu Hawaii
United States Advanced Laser Vision & Surgical Institute Houston Texas
United States Houston Eye Associates Houston Texas
United States Midwest Cornea Associates, LLC Indianapolis Indiana
United States Lakeside Vision Center Irvine California
United States Bowden Eye & Associates Jacksonville Florida
United States Moyes Eye Center Kansas City Missouri
United States Silverstein Eye Centers Kansas City Missouri
United States Jackson Eye Lake Villa Illinois
United States Lake Travis Eye & Laser Center Lakeway Texas
United States Hull Eye Center Lancaster California
United States Shettle Eye Research, Inc. Largo Florida
United States Emil A. Stein, M.D., Ltd. Las Vegas Nevada
United States Wellish Vision Institute Las Vegas Nevada
United States Sabates Eye Centers Leawood Kansas
United States Kentucky Eye Institute Lexington Kentucky
United States Koffler Vision Group Lexington Kentucky
United States Shire Call Center Lexington Massachusetts
United States Eye Physicians of Long Beach Long Beach California
United States Macy Eye Center Los Angeles California
United States Oxford Optical Los Angeles California
United States Sok H. Nam, M.D. Inc. Los Angeles California
United States University of Southern California Los Angeles California
United States Dr. Haider Eye Care Louisville Kentucky
United States Senior Health Services Louisville Kentucky
United States The Eye Care Institute Louisville Kentucky
United States Piedmont Eye Center, Inc. Lynchburg Virginia
United States University of Wisconsin Madison Wisconsin
United States Eye Specialty Group Memphis Tennessee
United States Total Eye Care, PA Memphis Tennessee
United States Ophthalmic Consultants of Connecticut Meriden Connecticut
United States Bascom Palmer Eye Institute Miami Florida
United States Lorites Medical Group Miami Florida
United States Millenium Clinical Research Miami Florida
United States Millennium Clinical Research, Inc. Miami Florida
United States South Florida Research Center Inc. Miami Florida
United States DCT- Shah Research, LLC dba Discovery Clinical Trials Mission Texas
United States North Valley Eye Medical Group Inc Mission Hills California
United States Eye Care Centers Management, Inc. Morrow Georgia
United States Saltzer Medical Group Nampa Idaho
United States Nashville Vision Associates Nashville Tennessee
United States Toyos Clinic Nashville Tennessee
United States Farkas, Kassalow, Resnick &Associates New York New York
United States Fichte, Endl& Elmer Eyecare Niagara Falls New York
United States IPS Research Company* Oklahoma City Oklahoma
United States Pediatric & Adult Research Center, LLC Orlando Florida
United States Baker, Carl W Paducah Kentucky
United States Specialty Eye Care Parker Colorado
United States Illinois Eye Center Peoria Illinois
United States North Bay Eye Associates, Inc. Petaluma California
United States Philadelphia Eye Associates Philadelphia Pennsylvania
United States Cornea and Cataract Consultants of Arizona Phoenix Arizona
United States Kannarr Eye Care Pittsburg Kansas
United States UPMC Eye Center Pittsburgh Pennsylvania
United States Medsol Clinical Research Center Port Charlotte Florida
United States Arch Health Partners Poway California
United States M&M Eye Institute Prescott Arizona
United States Oculus Research at Garner EyeCareCenter Raleigh North Carolina
United States Martel Eye Medical Group Rancho Cordova California
United States Black Hills Regional Eye Institute Rapid City South Dakota
United States Shasta Eye Medical Group, Inc. Redding California
United States Clinical Trials Research Roseville California
United States Sacramento Eye Consultants Sacramento California
United States Chrysalis Clinical Research Saint George Utah
United States Ophthalmology Associates Saint Louis Missouri
United States Opthalmology Consultants Ltd. Saint Louis Missouri
United States Tekwani Vision Center Saint Louis Missouri
United States Washington University Saint Louis Missouri
United States Score Physician Alliance, LLC Saint Petersburg Florida
United States Jean Brown Research Salt Lake City Utah
United States The Eye Institute of Utah Salt Lake City Utah
United States R and R Eye Research, LLC. San Antonio Texas
United States Sun Research Institute, LLC San Antonio Texas
United States WCCT Global (PH 1 Unit) Santa Ana California
United States Schwartz Laser Eye Center Scottsdale Arizona
United States Northern New Jersey Eye Institute South Orange New Jersey
United States Mercy Research Springfield Missouri
United States East Florida Eye Institute Stuart Florida
United States Lone Star Eye Care, P.A. Sugar Land Texas
United States Walman Eye Center Sun City Arizona
United States Andrew Gardner Logan, MD / dba Logan Ophthalmic Research, LLC Tamarac Florida
United States Logan Ophthalmic Research, LLC Tamarac Florida
United States International Research Center Tampa Florida
United States East West Eye Institute Torrance California
United States Wolstan & Goldberg Eye Associates Torrance California
United States South Shore Eye Care Wantagh New York
United States Eye Associates of Northeast Louisiana dba Haik Humble Eye Center West Monroe Louisiana
United States SkyVision Centers Westlake Ohio
United States Windham Eye Group Willimantic Connecticut
United States Clinical Eye Research of Boston Winchester Massachusetts
United States James Branch, M.D. Winston-Salem North Carolina
United States Wyomissing Optometric Center Wyomissing Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Shire

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Canada,  Estonia,  France,  Hungary,  Israel,  Italy,  Poland,  Puerto Rico,  South Africa,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Clinical Resolution Among Who Received SHP640 or Placebo on Day 5 Clinical resolution was defined as absence (score=0) of bulbar conjunctival injection and ocular conjunctival discharge in the study eye. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from validated bulbar redness (VBR) scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with score of at least 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline. Data analysis was performed in SHP640 and placebo reporting groups only but not in PVP-I 0.6%. Day 5
Secondary Number of Participants With Bacterial Eradication Among Who Received SHP640 or Placebo on Day 5 Bacterial eradication was defined as absence of all bacterial species present at or above pathological threshold at baseline in the study eye. Bacterial species were identified by Matrix Assisted Laser Desorption/Ionization-Time of Flight Mass Spectrometry, using their unique protein patterns. Pathological threshold for individual bacterial species was based on colony-forming unit (CFU)/mL threshold levels established by Cagle and modified by Leibowitz for different ocular bacterial species found in the specimens collected from each participant. Data analysis was performed in SHP640 and placebo reporting groups only but not in PVP-I 0.6%. Baseline, Day 5
Secondary Number of Participants With Clinical Resolution Clinical resolution was defined as absence (score=0) of bulbar conjunctival injection and ocular conjunctival discharge in the study eye. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with score of atleast 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline. Day 3, 8 and 12
Secondary Number of Participants With Bacterial Eradication Bacterial eradication was defined as absence of all bacterial species present at or above pathological threshold at baseline in the study eye. Bacterial species were identified by Matrix Assisted Laser Desorption/Ionization-Time of Flight Mass Spectrometry, using their unique protein patterns. Pathological threshold for individual bacterial species was based on CFU/mL threshold levels established by Cagle and modified by Leibowitz for different ocular bacterial species found in the specimens collected from each participant. Day 3, 8 and 12
Secondary Bulbar Conjunctival Injection Score Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Day 3, 5, 8 and 12
Secondary Change From Baseline in the Bulbar Conjunctival Injection Score Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Baseline, Day 3, 5, 8 and 12
Secondary Ocular Conjunctival Discharge Score Ocular conjunctival discharge was assessed based on a 0 (No evidence of discharge in the conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. Day 3, 5, 8 and 12
Secondary Change From Baseline in the Ocular Conjunctival Discharge Score Ocular conjunctival discharge was assessed based on a 0 (No evidence of discharge in the conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. Baseline, Day 3, 5, 8 and 12
Secondary Global Clinical Score Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with a score of at least 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline. Day 3, 5, 8 and 12
Secondary Change From Baseline in the Global Clinical Score Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with a score of at least 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline. Baseline, Day 3, 5, 8 and 12
Secondary Number of Participants With Modified Clinical Resolution Modified clinical resolution was defined as a global clinical score of 0 or 1. Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. Day 3, 5, 8 and 12
Secondary Number of Participants With Expanded Clinical Resolution Expanded clinical resolution was defined as a global clinical score of 0, 1, or 2 with neither injection nor discharge having a score of 2. Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. Day 3, 5, 8 and 12
Secondary Time to Clinical Resolution Clinical resolution was defined as absence (score of 0) of bulbar conjunctival injection and ocular conjunctival discharge in the study eye. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. Time to clinical resolution defined as the date on which a participant first reached clinical resolution minus the date of first dose of investigational product, plus 1. Baseline to Day 12
Secondary Number of Participants Who Used Rescue Medication Rescue treatment with a licensed antibiotic according to the local standard of care was provided to participants if, in the judgment of the investigator, there was no clinical improvement or worsening of their condition to an extent that it would be in the best interest of the participant treated with an alternate therapy for safety reasons. Baseline to Day 12
Secondary Number of Participants With Treatment-emergent Adverse Events (TEAEs) An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. Any AE that occured after the first dose of investigational product instillation was considered a TEAE. From start of study drug administration up to 14 days
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