Trial to Evaluate the Efficacy and Safety of IVIEW-1201 in Acute Bacterial Conjunctivitis

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

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

Study Overview

• Status: Completed
• Conditions: Acute Bacterial Conjunctivitis
• Intervention / Treatment: Drug: IVIEW-1201; Drug: Ofloxacin Eye Drops

• Study Type: Interventional
• Enrollment (Actual): 129
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Qi Zhu, MD; Phone Number: 617-431-7479; Email: qzhu@iviewinc.com

Study Locations

• China
  • SHAN DONG
    • Jinan, SHAN DONG, China, 250021
      • Eye Hospital of Shandong First Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IVIEW-1201	Drug: IVIEW-1201; Four times per day for day 1-2 and three times per day for day 3-7
Active Comparator: Ofloxacin Eye Drops	Drug: Ofloxacin Eye Drops; Four times per day for day 1-2 and three times per day for day 3-7

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical cure rate	The proportion of subjects with a score of 0 (on a 3-point scale; 0=Absent, 1=Mild, 2=Moderate, 3=Severe.) for bulbar conjunctival congestion and 0 (on a 3-point scale; 0=Absent, 1=Mild, 2=Moderate, 3=Severe.) for conjunctival secretion/exudation at Visit 4 (Day 8±1), Visit 5 (Day 14±1).	Day 8±1, Day 14±1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clearance rate	The clearance rate of each major pathogenic bacteria at Visit 2, 3, 4 and 5: Stratified analysis shall be conducted according to the type of pathogenic bacteria and the visit time point, and the clearance rate of each kind of bacteria by the investigational drug at different times shall be calculated. Bacterial clearance is defined as positive bacterial culture at baseline and negative bacterial culture at the last visit. Bacterial clearance rate = (number of subjects cleared + number of subjects assumed to be cleared) / total number of subjects enrolled × 100%.	Day 3, Day 6, Day 8±1, Day 14±1

Collaborators and Investigators

• Sponsor: IVIEW Therapeutics Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2023
• Primary Completion (Actual): September 13, 2023
• Study Completion (Actual): October 12, 2023

Study Registration Dates

• First Submitted: March 29, 2023
• First Submitted That Met QC Criteria: April 13, 2023
• First Posted (Actual): April 18, 2023

Study Record Updates

• Last Update Posted (Actual): October 18, 2023
• Last Update Submitted That Met QC Criteria: October 16, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Eye Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Conjunctival Diseases; Eye Infections, Bacterial; Eye Infections; Conjunctivitis; Conjunctivitis, Bacterial; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Pharmaceutical Solutions; Cytochrome P-450 CYP1A2 Inhibitors; Anti-Infective Agents, Urinary; Ophthalmic Solutions; Ofloxacin
• Other Study ID Numbers: IVIEW-1201-BAC-II

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No