| Eligibility |
Inclusion Criteria:
1. An understanding, ability, and willingness to fully comply with study procedures and
restrictions.
2. Ability to voluntarily provide written, signed, and dated to participate in the study.
3. Subjects of age 15 and over at Visit 1.
4. Have a positive AdenoPlus® test at Visit 1 in at least 1 eye.
5. Have a clinical diagnosis of suspected adenoviral conjunctivitis in at least 1 eye
(the same eye as the AdenoPlus positive eye) confirmed by the presence of the
following minimal clinical signs and symptoms in that same eye:
- Reported presence of signs and/or symptoms of adenoviral conjunctivitis for = 3
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. 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:
Subjects are excluded from the study if any of the following exclusion criteria are met.
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 subject 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 IVIEW-1201 clinical study.
5. Subjects 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 (eg,
uveitis, iritis, ulcerative keratitis, chronic blepharoconjunctivitis), other than
adenoviral conjunctivitis.
9. Have presence of corneal subepithelial infiltrates at Visit 1
10. Have at enrollment or within =30 days of Visit 1, a clinical presentation more
consistent with the diagnosis of ocular allergy, toxic conjunctivitis, or
non-adenoviral ocular infection (eg, bacterial, fungal, acanthamoebae, other or
parasitic).
11. Age under 15.
12. Prisoner.
13. Presence of nasolacrimal duct obstruction at Visit 1 (Day 1).
14. 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.
15. 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.
16. Presence of significant, active condition in the posterior segment which requires
invasive treatment (eg, intravitreal treatment with vascular endothelial growth factor
(VEGF) inhibitors or corticosteroids) and may progress during the study participation
period.
17. Have used any topical ocular or systemic anti-viral or antibiotics within <= 7 days of
enrollment.
18. Have used any topical ocular NSAIDs within <=1 day of enrollment.
19. Have used any topical ophthalmic steroids in the last <=14 days.
20. 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.
21. Have used non-corticosteroid immunosuppressive agents within <=14 days of Day 1, oral
or topical or both.
22. 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.
23. 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.
24. 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.
25. 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 IVIEW-sponsored study.
26. Pregnant women confirmed with dipstick urine pregnancy testing at Screening and at the
final visit.
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