Clinical trial NCT05816070: Trial to Evaluate the Efficacy and Safety of IVIEW-1201 in Acute Bacterial Conjunctivitis
Official title: A Phase II, Multi-Center, Randomized, Parallel Controlled Study to Evaluate the Clinical Efficacy and Safety of IVIEW 1201 Compared to Ofloxacin Eye Drops in the Treatment of Acute Bacterial Conjunctivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Bacterial Conjunctivitis
Lead sponsor: IVIEW Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2023-04-18
Enrollment: 129
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: Inclusion Criteria:

1. 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.
2. Aged above 15 ( inclusive), male or female.
3. A diagnosis of acute bacterial conjunctivitis based on clinical observations:

   1. a score of ≥1 for bulbar conjunctival congestion and ≥1 for conjunctival secretion/exudation in at least one eye (same eye);
   2. increased purulent, mucopurulent or mucopurulent secretions are observed in the conjunctival sac of the affected eye in all patients.
4. Willing to cooperate in the completion of all procedures and visits required for the trial.

Exclusion Criteria:

1. 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).
2. 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;
3. Symptoms or signs of bacterial conjunctivitis for more than 72 hours prior to screening;
4. Suspected fungal, viral or acanthamoeba infections based on clinical observations;
5. Those with severe keratitis or corneal opacity affecting the study results;
6. Active inflammation of the cornea, iris, or anterior chamber;
7. Corrected visual acuity of less than 0.2 in either eye;
8. History of eye surgery within 3 months prior to screening;
9. Those who have a history of acute or chronic dacryocystitis;
10. Those who need to wear corneal contact lenses during the trial;
11. Those who have used antibiotic eye drops or glucocorticoid eye drops within 14 days, and oral or intravenous antibiotics within 72 hours prior to screening;
12. Systemic use of steroidal drugs within 14 days prior to screening. Local use of eye steroidal drugs or nonsteroidal anti-inflammatory drugs (NSAIDs) within 7 days before enrollment (nasally or bronchially inhaled steroidal drugs are not allowed during the study);
13. Those with co-infections requiring treatment with other anti-infective drugs in the study;
14. Those who are using other drugs that may interfere with the efficacy or safety evaluation of the drug;
15. Participation in other interventional clinical trials within 30 days prior to the study;
16. Pregnant or lactating women, women with positive pregnancy tests and those planning to become pregnant (including male subjects); subjects who do not take effective contraceptive measures within 1 month before enrollment, or subjects (including male subjects) who are unwilling to take effective contraceptive measures within the next 6 months.
17. Other conditions or illnesses judged by the clinical investigator to be unsuitable for enrollment.

Primary outcomes:
measure: 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).
Secondary outcomes:
measure: Clearance Rate
timeFrame: Day 3, Day 6, Day 8±1, Day 14±1
Other outcomes:
Locations:
city: Jinan
country: China
facility: Eye Hospital of Shandong First Medical University
state: SHAN DONG
Study officials:
References: