Treatment of Bacterial Conjunctivitis With SHP640 Compared to PVP-Iodine and Placebo

Bacterial Conjunctivitis Clinical Trial

Official title:

A Phase 3, Multi-center, Randomized, Double-Masked Study to Evaluate the Clinical Efficacy and Safety of SHP640 (PVP-Iodine 0.6% and Dexamethasone 0.1%) Ophthalmic Suspension Compared to Placebo in the Treatment of Bacterial Conjunctivitis

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
• 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
• 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 AdenoPlus® 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.

Related Conditions & MeSH terms

• Bacterial Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Bacterial

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