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

NCT05816070 | Completed Phase 2 Results FDA Drug

• 1 other identifier: IVIEW-1201-BAC-II
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

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

Conditions

Acute Bacterial Conjunctivitis

Outcome Measures

Primary Outcomes (1)

• Clinical Cure Rate

  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).

  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 (1)

• Clearance Rate

  Day 3, Day 6, Day 8±1, Day 14±1

Study Arms (2)

IVIEW-1201

EXPERIMENTAL

Drug: IVIEW-1201

Ofloxacin Eye Drops

ACTIVE COMPARATOR

Drug: Ofloxacin Eye Drops

Interventions

IVIEW-1201 DRUG

Four times per day for day 1-2 and three times per day for day 3-7

IVIEW-1201

Ofloxacin Eye Drops DRUG

Four times per day for day 1-2 and three times per day for day 3-7

Ofloxacin Eye Drops

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• IVIEW Therapeutics Inc.: lead

Study Sites (1)

Eye Hospital of Shandong First Medical University

Jinan, Shandong, 250021, China

Location

Results Point of Contact

• Title: Bo Liang, PhD
• Organization: IVIEW Therapeutics Inc.

info@iviewinc.com

609 773 8580

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2023
• First Posted: April 18, 2023
• Study Start: January 5, 2023
• Primary Completion: November 13, 2023
• Study Completion: October 12, 2024
• Last Updated: December 2, 2025
• Results First Posted: June 15, 2025

Record last verified: 2025-11

Locations

CN (1)