Treatment of Adenoviral Conjunctivitis With SHP640 Compared to Placebo

Inclusion Criteria

1. An understanding, ability, and willingness to fully comply with study procedures and
restrictions (by the parent(s), guardian, or legally authorized representative, if
applicable).

2. 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.

3. 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 greater than or equal to (>=) 37 weeks
gestational age at birth).

4. 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 (example: 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 1 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 4a (a positive AdenoPlus test
in at least 1 eye), then the same eye must meet Inclusion Criterion 5.

5. 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: Report presence of signs and/or symptoms of adenoviral conjunctivitis for
less than or equal to (<=) 4 days prior to Visit 1; Bulbar conjunctival injection: a
grade of >=1 on 0-4 scale of Bulbar Conjunctival Injection Scale; Watery conjunctival
discharge: a grade of >=1 (mild) on a 0-3 Watery Conjunctival Discharge Scale.

6. Be willing to discontinue contact lens wear for the duration of the study.

7. 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 American Academy of
Pediatrics (AAP) Policy Statement for Visual System Assessment in Infants, Children,
and Young Adults by Pediatricians. 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.

8. 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

1. 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.

2. 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.

3. Have known or suspected intolerance or hypersensitivity to the investigational
product, closely related compounds, or any of the stated ingredients.

4. Prior enrollment in a FST-100 or SHP640 clinical study.

5. Participants who are employees, or immediate family members of employees (who are
directly related to study conduct), at the investigational site.

6. Have a history of ocular surgical intervention within <= 6 months prior to Visit 1 or
planned for the period of the study.

7. Have a preplanned overnight hospitalization during the period of the study.

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

9. Have presence of corneal subepithelial infiltrates at Visit 1.

10. Have active or history of ocular herpes.

11. 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
(example: bacterial, fungal, acanthamoebal, or other parasitic).

Note: History or concomitant presence of presumed seasonal or perennial allergic
conjunctivitis signs/symptoms is not exclusionary.

12. Neonates or infants (that is (ie,) participants < 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.

13. Neonates or infants (ie, participants < 12 months of age) whose birth mothers had any
sexually transmitted disease within 1 month of delivery or any history of genital
herpes.

14. Presence of nasolacrimal duct obstruction at Visit 1 (Day 1).

15. Presence of any significant ophthalmic condition (example: retinopathy of prematurity,
congenital cataract, congenital glaucoma) or other congenital disorder with ophthalmic
involvement that could affect study variables.

16. Be a known intraocular pressure (IOP) steroid responder, have a known history or
current diagnosis of glaucoma, or be a glaucoma suspect.

17. Have any known clinically significant optic nerve defects.

18. 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.

19. Presence of significant, active condition in the posterior segment which requires
invasive treatment (example: intravitreal treatment with VEGF inhibitors or
corticosteroids) and may progress during the study participation period.

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

21. Have used any topical ocular NSAIDs within <= 1 day of enrollment.

22. Have used any topical ophthalmic steroids in the last <= 14 days.

23. 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.

24. Have used non-corticosteroid immunosuppressive agents within <= 14 days of Day 1.

25. 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.

26. Have any significant ocular disease (example: Sjogren's syndrome) or any uncontrolled
systemic disease or debilitating disease (example: cardiovascular disease,
hypertension, sexually transmitted diseases/infections, diabetes or cystic fibrosis),
that may affect the study parameters, per investigator's discretion.

27. 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.

28. Within 30 days prior to the first dose of investigational product: Have used an
investigational product or device, or Have been enrolled in a clinical study
(including vaccine studies) that, in the investigator's opinion, may impact this
Shire-sponsored study.