Treatment of Adenoviral Conjunctivitis With SHP640 Compared to Povidone-iodine (PVP-I) and Placebo

Adenoviral 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 PVP-Iodine and Placebo in the Treatment of Adenoviral Conjunctivitis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02998541
• Other study ID #: SHP640-301
• Secondary ID: 2016-002439-14
• Status: Terminated
• Phase: Phase 3
• Start date: March 27, 2017
• Est. completion date: May 13, 2019

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 adenoviral conjunctivitis.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 219
• Est. completion date: May 13, 2019
• Est. primary completion date: May 13, 2019
• 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 lesser than (<) 3 months of age at Visit 1 must have been full-term, i.e. greater than or equal to (>=) 37 weeks gestational age at birth).

• Meet at least 1 of the 2 criteria below:

a) Have a positive AdenoPlus test at Visit 1 in at least 1 eye. b) Have at least 2 of the following 5 criteria, based upon medical history and examination: i.Symptoms within the past 7 days consistent with acute upper respiratory tract infection (eg. sore throat, cough, rhinorrhea, etc).

ii. Contact within the past 7 days with family members or other individuals with recent onset of symptoms consistent with conjunctivitis iii. Acute onset within the past 4 days of one or more of the following ocular symptoms: burning/irritation, foreign body sensation, light sensitivity.

iv. Enlarged periauricular lymph node(s). v. Presence of follicles on tarsal conjunctiva. Note:If the participant only meets Inclusion Criterion (a positive AdenoPlus test in at least 1 eye), then the same eye must meet the mentioned below Inclusion Criterion.

• Have a clinical diagnosis of suspected adenoviral 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 adenoviral conjunctivitis for lesser than or equal to (<=) 4 days prior to Visit 1

2. Bulbar conjunctival injection: a grade of >= 1 (mild) on a 0-4 Bulbar Conjunctival Injection Scale.

3. Watery conjunctival discharge: a grade of >= 1 (mild) on a 0-3 Watery 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 the 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 participants 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 pre-planned overnight hospitalization during the period of the study.

• Have presence of any intraocular, corneal, or conjunctival ocular inflammation (eg, uveitis, iritis, ulcerative keratitis, chronic blepharoconjunctivitis), other than adenoviral conjunctivitis.

• Have presence of corneal subepithelial infiltrates at Visit 1.

• Have active or 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-adenoviral ocular infection (e.g. bacterial, 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 (i.e. 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 (i.e. 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 (e.g. 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 which requires invasive treatment (e.g. intravitreal treatment with VEGF inhibitors or corticosteroids) and may progress during the study participation period.

• Have used any topical ocular or systemic anti-vials or antibiotics within <= 7 days of enrollment.

• Have used any topical ocular Non-steroidal Anti-inflammataory Drugs (NSAIDs) 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 peri-ocular 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 the 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 (antihepatitis 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

• Adenoviral Conjunctivitis
• Conjunctivitis

Intervention

Drug:
• SHP640
Participants will receive one drop of SHP640 (0.1 % dexamethasone and 0.6% PVP-I) ophthalmic suspension in each eye QID (with a minimum of 2 hours between doses) for 7 days.
• PVP-I 0.6%
Participants will receive one drop of PVP-I ophthalmic solution in each eye QID (with a minimum of 2 hours between doses) for 7 days.

Other:
• Placebo
Participants will receive one drop of placebo ophthalmic solution in each eye 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	Kepler Universitätsklinikum	Linz
Austria	AKH - Medizinische Universitaet Wien	Vienna
Austria	Vienna Institute for Research in Ocular Surgery	Vienna
Canada	McGill University Health Centre/Glen Site / Royal Victoria Hospital	Montreal	Quebec
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	Tallinn
Estonia	Eye Clinic Dr Kirsta Turman	Tallinn
Estonia	Tartu University Hospital	Tartu
France	CHU Limoges - Hopital Dupuytren	Limoges	Haute Vienne
France	Hopital Necker - Enfants Malades	Paris
Germany	Klinisches Studienzentrum der Augenklinik	Mainz
Germany	Augenärzte am Franziskus Hospital	Muenster
Hungary	Debreceni Egyetem	Debrecen
Hungary	Bugat Pal Korhaz	Gyongyos	Heves
Hungary	Somogy Megyei Kaposi Mor Oktato Korhaz	Kaposvár
Hungary	Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont	Szeged	Csongrad
Hungary	Csolnoky Ferenc Korhaz	Veszprem
India	Bhagwan Mahaveer Jain Hospital	Bangalore	Karnataka
India	M. S. Ramaiah Medical College and Hospital	Bangalore	Karnataka
India	Sankara Eye Hospital	Bangalore	Karnataka
India	Sapthagiri Hospital	Bangalore	Karnataka
India	K.L.E. Society's Dr. Prabhakar Kore Hospital and Medical Research Centre	Belgaum	Karnataka
India	S. P. Medical College & Associated Group of Hospitals	Bikaner	Rajasthan
India	L. V. Prasad Eye Institute	Hyderabad	Andhra Pradesh
India	Regional Institute of Ophthalmology	Kolkata	West Bengal
India	NKP Salve Institute of Medical Sciences	Nagpur	Maharashtra
India	Dr. D. Y. Patil Medical College	Navi Mumbai	Maharashtra
India	ICARE Eye Hospital and Post Graduate Institute	Noida	Uttar Pradesh
India	PBMA'S H. V. Desai Eye Hospital	Pune	Maharashtra
Israel	HaEmek Medical Center	Afula
Israel	Soroka University Medical Center	Beer Sheva
Israel	Rambam MC	Haifa
Israel	Shaare Zedek Medical Center	Jerusalem
Israel	Rabin Medical Center-Beilinson Campus	Petah Tikva
Israel	Kaplan Medical Center	Rehovot
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv
Italy	A.O.U. Policlinico San'Orsola-Malpighi	Bologna
Peru	Instituto Regional de Oftalmología	La Libertad
Peru	Macula D&T S.R.L.	Lima
Peru	Oftalmosalud SRL.	Lima
Poland	Szpital Specjalistyczny nr 1	Bytom
Poland	Centrum Medyczne UNO-MED	Krakow
Poland	Centrum Diagnostyki i Mikrochirurgii Oka LENS	Olsztyn
Poland	Centrum Medyczne Uno-Med (Private Practice)	Tarnów
Poland	Retina Sp. z o.o.	Warszawa
South Africa	Nelson R Mandela School of Medicine Ophthalmology Department	Durban	KwaZulu-Natal
South Africa	Newtown Clinical Research	Johannesburg	Gauteng
South Africa	Into Research	Pretoria	Gauteng
South Africa	Pretoria Eye Institute Research Foundation	Pretoria	Gauteng
Spain	Complejo Asistencial Universitario de Burgos	Burgos
Spain	Hospital Universitari de Girona Dr Josep Trueta	Girona
Spain	Clinica Oftalmologia Gil Piña	Huelva
Spain	Clinica Rementeria	Madrid
Spain	Hospital Universitario Puerta de Hierro Majadahonda	Majadahonda
Spain	Instituto Oftalmológico Fernández-Vega	Oviedo	Asturias
Spain	Cartuja Vision	Sevilla
Spain	FISABIO-Oftalmología Médica	Valencia
Spain	Hospital Clinico Universitario Lozano Blesa	Zaragoza
Spain	Hospital Universitario Miguel Servet	Zaragoza
United Kingdom	Manchester Royal Eye Hospital	Manchester	Greater Manchester
United States	The Regents of the University of Michigan	Ann Arbor	Michigan
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	Minnesota Eye Consultants, P.A.	Bloomington	Minnesota
United States	Massachusetts Eye and Ear Infirmary	Boston	Massachusetts
United States	The Eye Associates	Bradenton	Florida
United States	Arizona Eye Center	Chandler	Arizona
United States	Lifelong Vision Foundation	Chesterfield	Missouri
United States	Ericksen Research & Development, LLC	Clinton	Utah
United States	Matossian Eye Associates	Doylestown	Pennsylvania
United States	MediSphere Medical Research Center, an AMR affiliate	Evansville	Indiana
United States	Emerson Clinical Research Institute, LLC	Falls Church	Virginia
United States	South Florida Vision Associates, LLC	Fort Lauderdale	Florida
United States	Midwestern University Eye Institute	Glendale	Arizona
United States	Mark B. Kislinger, MD, PhD, Inc.	Glendora	California
United States	Lakeview Vision - Gretna	Gretna	Louisiana
United States	Inland Eye Specialists	Hemet	California
United States	Houston Eye Associates	Houston	Texas
United States	Lakeside Vision Center	Irvine	California
United States	Moyes Eye Center	Kansas City	Missouri
United States	Jackson Eye	Lake Villa	Illinois
United States	Lake Travis Eye & Laser Center	Lakeway	Texas
United States	Nevada Eye Care Professionals	Las Vegas	Nevada
United States	Houston Eye Associates	League City	Texas
United States	Kentucky Eye Institute	Lexington	Kentucky
United States	Koffler Vision Group	Lexington	Kentucky
United States	Shire Call Center	Lexington	Massachusetts
United States	Loma Linda University	Loma Linda	California
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	Senior Health Services	Louisville	Kentucky
United States	University of Wisconsin	Madison	Wisconsin
United States	Eye Specialty Group	Memphis	Tennessee
United States	The Eye Center at Southern College of Optometry	Memphis	Tennessee
United States	Total Eye Care, PA	Memphis	Tennessee
United States	Bascom Palmer Eye Institute	Miami	Florida
United States	Lorites Medical Group	Miami	Florida
United States	DCT-Shah Research, LLC dba Discovery Clinical Trials	Mission	Texas
United States	Eye Care Centers Management, Inc.	Morrow	Georgia
United States	Nashville Vision Associates	Nashville	Tennessee
United States	Toyos Clinic	Nashville	Tennessee
United States	Shultz Chang Vision	Northridge	California
United States	Pediatric & Adult Research Center, LLC	Orlando	Florida
United States	Baker, Carl W	Paducah	Kentucky
United States	Stanford Byers Eye Institute	Palo Alto	California
United States	Illinois Eye Center	Peoria	Illinois
United States	North Bay Eye Associates, Inc.	Petaluma	California
United States	Kannarr Eye Care	Pittsburg	Kansas
United States	UPMC Eye Center	Pittsburgh	Pennsylvania
United States	Arch Health Partners	Poway	California
United States	M&M Eye Institute	Prescott	Arizona
United States	Oculus Research	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	R and R Eye Research, LLC.	San Antonio	Texas
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	Haik Humble Eye Center	West Monroe	Louisiana
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,  Germany,  Hungary,  India,  Israel,  Italy,  Peru,  Poland,  South Africa,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Clinical Resolution Among Who Received SHP640 or Placebo on Day 6	Clinical resolution of adenoviral conjunctivitis was defined as the absence (score=0) of bulbar conjunctival injection and watery conjunctival discharge in the study eye. The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her cell culture-immunofluorescence assay (CC-IFA) results at baseline. Bulbar conjunctival injection was assessed based on a 0 (Normal conjunctival vascular pattern)-4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from the validated bulbar redness (VBR) scale. Watery conjunctival discharge was assessed based on a 0-3 scale (0 - None and 3 - Severe: Abundant quantity of watery discharge observed in the lower conjunctival fornix and in the lower lid margin). Higher score represent worse symptoms for both scores. Data analysis was performed in SHP640 and placebo reporting groups only but not in PVP-I 0.6%.	Day 6
Secondary	Number of Participants With Clinical Resolution Among Who Received SHP640 or Povidone-Iodine (PVP-I) on Day 6	Clinical resolution of adenoviral conjunctivitis was defined as the absence (score=0) of bulbar conjunctival injection and watery conjunctival discharge in the study eye. The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline. Bulbar conjunctival injection was assessed based on a 0 (Normal conjunctival vascular pattern)-4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from the validated bulbar redness (VBR) scale. Watery conjunctival discharge was assessed based on a 0-3 scale (0 - None and 3 - Severe: Abundant quantity of watery discharge observed in the lower conjunctival fornix and in the lower lid margin). Higher score represent worse symptoms for both scores. Data analysis was performed in SHP640 and PVP-I 0.6% reporting groups only but not in placebo.	Day 6
Secondary	Number of Participants With Clinical Resolution Among Who Received Povidone-Iodine (PVP-I) or Placebo on Day 6	Clinical resolution of adenoviral conjunctivitis was defined as the absence (score=0) of bulbar conjunctival injection and watery conjunctival discharge in the study eye. The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline. Bulbar conjunctival injection was assessed based on a 0 (Normal conjunctival vascular pattern)-4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from the validated bulbar redness (VBR) scale. Watery conjunctival discharge was assessed based on a 0-3 scale (0 - None and 3 - Severe: Abundant quantity of watery discharge observed in the lower conjunctival fornix and in the lower lid margin). Higher score represent worse symptoms for both scores. Data analysis was performed in PVP-I 0.6% and placebo reporting groups only but not in SHP640.	Day 6
Secondary	Number of Participants With Adenoviral Eradication Among Who Received Povidone-Iodine (PVP-I) or Placebo on Day 3	Adenoviral eradication for the study eye was defined as negative Cell Culture- Immunofluorescence Assay (CC-IFA) in that eye. CC-IFA for each eye was conducted using conjunctival swab samples collected at each visit to determine the presence of adenovirus. The study eye was defined based on participants bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline. Data analysis was performed in PVP-I 0.6% and placebo reporting groups only but not in SHP640.	Day 3
Secondary	Number of Participants With Adenoviral Eradication Among Who Received SHP640 or Placebo on Day 6	Adenoviral eradication for the study eye was defined as negative CC-IFA in that eye. CC-IFA for each eye was conducted using conjunctival swab samples collected at each visit to determine the presence of adenovirus. The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline. Data analysis was performed in SHP640 and placebo reporting groups only but not in PVP-I 0.6%.	Day 6
Secondary	Number of Participants With Adenoviral Eradication Among Who Received SHP640 or Povidone-Iodine (PVP-I) on Day 6	Adenoviral eradication for the study eye was defined as negative CC-IFA in that eye. CC-IFA for each eye was conducted using conjunctival swab samples collected at each visit to determine the presence of adenovirus. The study eye was defined based on participants bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline. Data analysis was performed in SHP640 and PVP-I 0.6% reporting groups only but not in placebo.	Day 6
Secondary	Percent Change From Baseline in Adenovirus Viral Titer as Assessed by Quantitative Polymerase Chain Reaction (qPCR) at Day 6 and 8	qPCR test was performed on all CC-IFA positive samples at all visits to determine viral count in the study eye. The study eye was defined based on participants bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline. Percent (%) change from baseline in adenovirus viral titer as assessed by qPCR was reported.	Day 6 and 8
Secondary	Number of Participants With Adenoviral Eradication on Day 8 and 12/Early Termination (ET)	Adenoviral eradication for the study eye was defined as negative CC-IFA in that eye. CC-IFA for each eye was conducted using conjunctival swab samples collected at each visit to determine the presence of adenovirus. The study eye was defined based on participants bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline.	Day 8 and 12/ET
Secondary	Number of Participants With Clinical Resolution on on Day 3, 8 and 12/Early Termination (ET)	Clinical resolution of adenoviral conjunctivitis was defined as the absence (score=0) of bulbar conjunctival injection and watery conjunctival discharge in the study eye. The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline. Bulbar conjunctival injection was assessed based on a 0 (Normal conjunctival vascular pattern)-4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from the validated bulbar redness (VBR) scale. Watery conjunctival discharge was assessed based on a 0-3 scale (0 - None and 3 - Severe: Abundant quantity of watery discharge observed in the lower conjunctival fornix and in the lower lid margin). Higher score represent worse symptoms for both scores.	Day 3, 8 and 12/ET
Secondary	Change From Baseline in Individual Clinical Signs Score at Day 3, 6, 8 and 12/Early Termination (ET)	The Individual clinical signs score (bulbar conjunctival injection and watery conjunctival discharge) in the study were reported. The study eye was defined based on participants bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CCIFA results at baseline.	Day 3, 6, 8 and 12/ET
Secondary	Number of Participants With at Least 2 Point Reduction From Baseline in the Global Clinical Score at Day 3, 6, 8 and 12/Early Termination (ET)	Global clinical score was the sum of bulbar conjunctival injection and watery conjunctival discharge. The study eye was defined based on participants bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline.	Day 3, 6, 8 and 12/ET
Secondary	Number of Participants With Modified Clinical Resolution on Day 3, 6, 8 and 12/Early Termination (ET)	Modified clinical resolution was defined as a global clinical score of 0 or 1. Global clinical score was the sum of bulbar conjunctival injection and watery conjunctival discharge. The study eyewas defined based on participants bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline.	Day 3, 6, 8 and 12/ET
Secondary	Number of Participants With Expanded Clinical Resolution on Day 3, 6, 8 and 12/Early Termination (ET)	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 the sum of bulbar conjunctival injection and watery conjunctival discharge. The study eye was defined based on participants bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline.	Day 3, 6, 8 and 12/ET
Secondary	Number of Participants With Status of Cross-over Infection on Day 3, 6, 8 and 12/Early Termination (ET)	Number of participants with status of cross-over infection to a participant's fellow eye. Participants with only 1 infected eye at baseline were reported.	Day 3, 6, 8 and 12/ET
Secondary	Time to Clinical Resolution on Day 3, 6, 8 and 12/Early Termination (ET)	Time to clinical resolution were reported based on the assessments in the study eye.	Day 3, 6, 8 and 12/ET
Secondary	Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Event (SAEs) of SHP640	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. A SAE was any untoward medical occurrence (whether considered to be related to investigational product or not) that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality/birth defect, is an important medical event. Any AE that occured after the first dose of IP instillation was considered a TEAE.	From start of the study up to Day 14