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

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2023
INTERVENTION: Intervention1: IVIEW‐1201: Instill 1 drop of IVIEW‐1201 (1.0% povidone‐iodine [PVP‐I]) gel forming ophthalmic solution in each eye 4 times daily (QID) (with a minimum of 3 hours between doses) for 7 days. Control Intervention1: Placebo: Instill 1 drop of placebo ophthalmic solution in each eye QID for 7 days. CONDITION: Health Condition 1: B301‐ Conjunctivitis due to adenovirus PRIMARY OUTCOME: To evaluate the efficacy of IVIEW 1201 relative to placebo in patients with Adenoviral ; conjunctivitis. Endpoint is Clinical Resolution as measured by bulbar conjunctival injection and ; watery conjunctival dischargeTimepoint: Day 6 SECONDARY OUTCOME: Adenoviral Eradication rates of IVIEW‐1201 vs. placebo as measured by negative cell cultureimmunofluorescence ; assay (CC‐IFA)Timepoint: Day 6 Clinical cure rates defined as a rating of 0/3 for bulbar conjunctival injection and 0/3 for ; conjunctival exudates/dischargeTimepoint: Day 3, 8, and 14 Microbiological cure rate defined as the percentage of study participants who demonstrate ; reduction of qPCR titers and eradication of infectious virus as determined by CC‐IFATimepoint: Day 3,8,and 14 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
Epistemonikos ID: 6e36630909fcafe6a186dece235e6c678071db99
First added on: Feb 20, 2024