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

Recruitment & Eligibility

Status: Other (Terminated)

Sex: Not specified

Target Recruitment: 44

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 AdenoPlusÂ® 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 AdenoPlusÂ® 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. 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.

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.

6. Have a history of ocular surgical intervention within less than or equl to 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, acanthamoebal, other or parasitic).

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

12. 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. 13. Have any known clinically significant optic nerve defects.

14. 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.

15. 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.

16. Have used any topical ocular or systemic anti-virals or antibiotics within less than or equal to days of enrollment.

17. Have used any topical ocular NSAIDs within less than or equal to day of enrollment.

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

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

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

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

22. Have any significant ocular disease for example Sjogren syndrome or any uncontrolled systemic disease or debilitating disease for example cardiovascular disea

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint will be percentage achieving a clinical cure defined as a rating of 0/3 for bulbar conjunctival injection and 0/3 for conjunctival exudates/discharge by Day 6 +/- 1 Day of onset.Timepoint: The primary endpoint will be percentage achieving a clinical cure defined as a rating of 0/3 for bulbar conjunctival injection and 0/3 for conjunctival exudates/discharge by Day 6 +/- 1 Day of onset.

Secondary Outcome Measures

Name	Time	Method
Adenoviral Eradication rates of IVIEW-1201 vs. placebo as measured by negative cell culture immunofluorescence assay (CC-IFA)Timepoint: Day 6

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