To study the efficacy of drug (IVIEW-1201) in the Treatment of Acute Adenoviral Conjunctivitis

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 130

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 consent/assent to participate in the

study.

3 Subjects of age 15 and over at Visit 1.

4 Have a positive QuickVue Adenoviral conjunctivitis 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:

a. Report presence of signs and/or symptoms of adenoviral conjunctivitis for equal to or less than 3 days prior to Visit 1

b. Bulbar conjunctival injection: a grade of equal to or more than 1 on 0-4 scale of Bulbar Conjunctival Injection Scale

c. Watery conjunctival discharge: a grade of equal to or more than 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

1 Current or recurrent disease that could affect the action, absorption, or disposition of the

investigational product, or clinical or laboratory assessments, per investigators 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, acantamoeba, 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 any known clinically significant optic nerve defects.

16. 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.

17. Presence of significant, active condition in the posterior segment which requires invasive

treatment (eg, intravitreal treatment with VEGF inhibitors or corticosteroids) and may

progress during the study participation period.

18. Have used any topical ocular or systemic anti-virals or antibiotics within less than or equal 7

days of enrollment.

19. Have used any topical ocular NSAIDs within less than or equal 1 day of enrollment.

20. Have used any topical ophthalmic steroids in the last less than or equal to 14 days.

21. Have used any systemic corticosteroid agents within less than or equal to 14 days of Day 1. Stable (initiated less than or equal to 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.

22. Have used non-corticosteroid immunosuppressive agents within less than or equal to 14 days of Day 1, oral or topical or both.

23. Have used any topical ophthalmic products, including tear substitutes, and over-thecounter

preparations

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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