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

Primary Purpose

Acute Bacterial Conjunctivitis

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
IVIEW-1201
Ofloxacin Eye Drops
Sponsored by
IVIEW Therapeutics Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Bacterial Conjunctivitis

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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; Suspected fungal, viral or acanthamoeba infections based on clinical observations; Those with severe keratitis or corneal opacity affecting the study results; Active inflammation of the cornea, iris, or anterior chamber; Corrected visual acuity of less than 0.2 in either eye; History of eye surgery within 3 months prior to screening; Those who have a history of acute or chronic dacryocystitis; Those who need to wear corneal contact lenses during the trial; 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; 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); Those with co-infections requiring treatment with other anti-infective drugs in the study; Those who are using other drugs that may interfere with the efficacy or safety evaluation of the drug; Participation in other interventional clinical trials within 30 days prior to the study; 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. Other conditions or illnesses judged by the clinical investigator to be unsuitable for enrollment.

Sites / Locations

  • Eye Hospital of Shandong First Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IVIEW-1201

Ofloxacin Eye Drops

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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%.

Full Information

First Posted
March 29, 2023
Last Updated
October 16, 2023
Sponsor
IVIEW Therapeutics Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05816070
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
January 5, 2023 (Actual)
Primary Completion Date
September 13, 2023 (Actual)
Study Completion Date
October 12, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IVIEW Therapeutics Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Bacterial Conjunctivitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
129 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IVIEW-1201
Arm Type
Experimental
Arm Title
Ofloxacin Eye Drops
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
IVIEW-1201
Intervention Description
Four times per day for day 1-2 and three times per day for day 3-7
Intervention Type
Drug
Intervention Name(s)
Ofloxacin Eye Drops
Intervention Description
Four times per day for day 1-2 and three times per day for day 3-7
Primary Outcome Measure Information:
Title
Clinical cure rate
Description
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).
Time Frame
Day 8±1, Day 14±1
Secondary Outcome Measure Information:
Title
Clearance rate
Description
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%.
Time Frame
Day 3, Day 6, Day 8±1, Day 14±1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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; Suspected fungal, viral or acanthamoeba infections based on clinical observations; Those with severe keratitis or corneal opacity affecting the study results; Active inflammation of the cornea, iris, or anterior chamber; Corrected visual acuity of less than 0.2 in either eye; History of eye surgery within 3 months prior to screening; Those who have a history of acute or chronic dacryocystitis; Those who need to wear corneal contact lenses during the trial; 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; 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); Those with co-infections requiring treatment with other anti-infective drugs in the study; Those who are using other drugs that may interfere with the efficacy or safety evaluation of the drug; Participation in other interventional clinical trials within 30 days prior to the study; 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. Other conditions or illnesses judged by the clinical investigator to be unsuitable for enrollment.
Facility Information:
Facility Name
Eye Hospital of Shandong First Medical University
City
Jinan
State/Province
SHAN DONG
ZIP/Postal Code
250021
Country
China

12. IPD Sharing Statement

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

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