Trial to Evaluate the Efficacy and Safety of IVIEW-1201 in Acute Viral Conjunctivitis (NCT03749317) | Clinical Trial Compass
CompletedPhase 2
Trial to Evaluate the Efficacy and Safety of IVIEW-1201 in Acute Viral Conjunctivitis
India135 participantsStarted 2023-02-20
Plain-language summary
A Phase 2, Multi-center, Randomized, Double-Masked Study to Evaluate the Clinical Efficacy and Safety of IVIEW-1201 (1.0% Povidone-Iodine) Gel Forming Ophthalmic Solution Compared to Placebo in the Treatment of Adenoviral Conjunctivitis
Who can participate
Age range15 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. An understanding, ability, and willingness to fully comply with study procedures and restrictions.
✓. Ability to voluntarily provide written, signed, and dated to participate in the study.
✓. Subjects of age 15 and over at Visit 1.
✓. Have a positive AdenoPlus® test at Visit 1 in at least 1 eye.
✓. 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:
✓. Be willing to discontinue contact lens wear for the duration of the study.
✓. 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
✕. 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.
✕. 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.
✕. Have known or suspected intolerance or hypersensitivity to the investigational product, closely related compounds, or any of the stated ingredients.
What they're measuring
1
Clinical resolution by assessment of bulbar conjunctival injection and watery conjunctival discharge
✕. Prior enrollment in IVIEW-1201 clinical study.
✕. Subjects who are employees, or immediate family members of employees (who are directly related to study conduct), at the investigational site.
✕. Have a history of ocular surgical intervention within ≤ 6 months prior to Visit 1 or planned for the period of the study.
✕. Have a preplanned overnight hospitalization during the period of the study.
✕. Have presence of any intraocular, corneal, or conjunctival ocular inflammation (eg, uveitis, iritis, ulcerative keratitis, chronic blepharoconjunctivitis), other than adenoviral conjunctivitis.