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

Inclusion Criteria:

• An understanding, ability, and willingness to fully comply with study procedures andrestrictions (by the parent(s), guardian, or legally authorized representative, ifapplicable).
• Ability to voluntarily provide written, signed, and dated (personally or via aparent(s), guardian, or legally authorized representative(s) informed consent (andassent, if applicable) to participate in the study.
• Participants of any age at Visit 1 (Note: participants lesser than (<) 3 months of ageat Visit 1 must have been full-term, i.e. greater than or equal to (>=) 37 weeksgestational 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 ofthe following 5 criteria, based upon medical history and examination: i.Symptomswithin 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 recentonset of symptoms consistent with conjunctivitis iii. Acute onset within the past 4 days ofone 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 atleast 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 eyeconfirmed by the presence of the following minimal clinical signs and symptoms in thatsame eye:

1. Report presence of signs and/or symptoms of adenoviral conjunctivitis for lesserthan or equal to (<=) 4 days prior to Visit 1
2. Bulbar conjunctival injection: a grade of >= 1 (mild) on a 0-4 BulbarConjunctival Injection Scale.
3. Watery conjunctival discharge: a grade of >= 1 (mild) on a 0-3 WateryConjunctival 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 asmeasured using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. BCVA willbe assessed by an age appropriate method in accordance with the AAP Policy Statementfor Visual System Assessment in Infants, Children, and Young Adults by Pediatricians (Donahue and Baker 2016; American Academy of Pediatrics 2016).The policy statementrecommends formal vision screening can begin at 3 years of age. VA measurements forchildren 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, exceptparticipants <2 months of age who have not yet developed this ability. Participants <2months will be enrolled at the discretion of the investigator.
• Male, or non-pregnant, non-lactating female who agrees to comply with any applicablecontraceptive requirements of the protocol or females of non-childbearing potential.

Exclusion Criteria:

• Current or recurrent disease that could affect the action, absorption, or dispositionof the investigational product, or clinical or laboratory assessments, perinvestigator's discretion.
• Current or relevant history of physical or psychiatric illness, any medical disorderthat may make the participants unlikely to fully complete the study, or any conditionthat presents undue risk from the investigational product or procedures.
• Have known or suspected intolerance or hypersensitivity to the investigationalproduct, 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 aredirectly related to study conduct), at the investigational site.
• Have a history of ocular surgical intervention within <= 6 months prior to Visit 1 orplanned 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 thanadenoviral 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 moreconsistent with the diagnosis of non-infectious conjunctivitis (except presumedseasonal/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 allergicconjunctivitis signs/symptoms is not exclusionary.
• Neonates or infants (i.e. participants less than 12 months of age) who have suspectedor 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 mothershad any sexually transmitted disease within 1 month of delivery or any history ofgenital 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 ophthalmicinvolvement that could affect study variables.
• Be a known intraocular pressure (IOP) steroid responder, have a known history orcurrent 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 secondaryto previous corneal trauma or dry eye syndrome; presence of corneal epithelial defector any significant corneal opacity at Visit 1.
• Presence of significant, active condition in the posterior segment which requiresinvasive treatment (e.g. intravitreal treatment with VEGF inhibitors orcorticosteroids) and may progress during the study participation period.
• Have used any topical ocular or systemic anti-vials or antibiotics within <= 7 days ofenrollment.
• 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 isallowed, given no anticipated change in dose for the duration of the study. Topicaldermal 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, andover-the-counter preparations such as lid scrubs, within 2 hours of Visit 1 and beunable 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 uncontrolledsystemic disease or debilitating disease (eg, cardiovascular disease, hypertension,sexually transmitted diseases/infections, diabetes or cystic fibrosis), that mayaffect the study parameters, per the investigator's discretion.
• Any known history of immunodeficiency disorder or known active conditions predisposingto immunodeficiency, such as human immunodeficiency virus, hepatitis B or C, evidenceof active hepatitis A (antihepatitis A virus immunoglobulin M), or organ or bonemarrow 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 theinvestigator's opinion, may impact this Shire-sponsored study