Trial to Evaluate the Efficacy and Safety of IVIEW-1201 in Acute Bacterial Conjunctivitis (NCT05816070) | Clinical Trial Compass
CompletedPhase 2
Trial to Evaluate the Efficacy and Safety of IVIEW-1201 in Acute Bacterial Conjunctivitis
China129 participantsStarted 2023-01-05
Plain-language summary
A Phase 2, Multi-center, Randomized, Parallel Controlled Study to Evaluate the Clinical Efficacy and Safety of IVIEW-1201 (1.0% Povidone-Iodine) Gel Forming Ophthalmic Solution Compared to Ofloxacin Eye Drops in the Treatment of Acute Bacterial Conjunctivitis
Who can participate
Age range15 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
✓. Volunteered to participate in the study and signed the Informed Consent Form after receiving a verbal and written explanation of this clinical trial. In cases where the subject is unable to sign the Informed Consent Form, his/her guardian may sign in accordance with relevant regulations.
✓. Aged above 15 ( inclusive), male or female.
✓. A diagnosis of acute bacterial conjunctivitis based on clinical observations:
✓. a score of ≥1 for bulbar conjunctival congestion and ≥1 for conjunctival secretion/exudation in at least one eye (same eye);
✓. increased purulent, mucopurulent or mucopurulent secretions are observed in the conjunctival sac of the affected eye in all patients.
✓. Willing to cooperate in the completion of all procedures and visits required for the trial.
Exclusion criteria
✕. Patients with systemic or ocular diseases, or functional disorders with comorbidities, or structural abnormalities that, in the judgment of the investigator, could adversely affect the course or results of the trial (e.g., hyperthyroidism, hepatitis, acute and chronic renal insufficiency).
✕. Those who have a history of allergy or serious adverse reactions to any component of IVIEW 1201 (1.0% povidone iodine ophthalmic gel sterile solution) and Of laxacin Eye Drops; have a history of allergy or serious adverse reactions to quinolones; or have a cumulative total of three or more allergies to other drugs, food and environment; or who are prone to allergic symptoms such as rash and urticaria;
✕. Symptoms or signs of bacterial conjunctivitis for more than 72 hours prior to screening;
What they're measuring
1
Clinical Cure Rate
Timeframe: Take the visit 4 (Day 8±1) data, unless the subject was not cured and did not continue the treatment after visit 4 (Day 8±1) , in which case, visit 5 (Day 14±1) data would be used instead of Visit 4 data (Day 8±1).