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

IVIEW Therapeutics Inc.1 site in 1 country129 target enrollmentJanuary 5, 2023

ConditionsAcute Bacterial Conjunctivitis

InterventionsOfloxacin Eye Drops IVIEW-1201

DrugsIVIEW-1201 Ofloxacin Eye Drops

Overview

Phase: Phase 2
Intervention: Ofloxacin Eye Drops
Conditions: Acute Bacterial Conjunctivitis
Sponsor: IVIEW Therapeutics Inc.
Enrollment: 129
Locations: 1
Primary Endpoint: Clinical Cure Rate
Status: Completed
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

January 5, 2023

End Date

October 12, 2024

Last Updated

5 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

IVIEW Therapeutics Inc.

Responsible Party

Sponsor

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;

Arms & Interventions

Ofloxacin Eye Drops

Intervention: Ofloxacin Eye Drops

IVIEW-1201

Intervention: IVIEW-1201

Outcomes

Primary Outcomes

Clinical Cure Rate

Time Frame: 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).

The proportion of subjects with a score of 0 (0=Absent, 1=Mild, 2=Moderate, 3=Severe.) for bulbar conjunctival congestion and 0 (0=Absent, 1=Mild, 2=Moderate, 3=Severe.) for conjunctival secretion/exudation at Visit 4 (Day 8±1), Visit 5 (Day 14±1).