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 range
15 Years – 70 Years
Sex
ALL
See this in plain English?
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinical resolution by assessment of bulbar conjunctival injection and watery conjunctival discharge
. Have known or suspected intolerance or hypersensitivity to the investigational product, closely related compounds, or any of the stated ingredients.
. 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.