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Completed

NCT Number: NCT05816070

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

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Key information

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Eye Hospital of Shandong First Medical University

Jinan, Shandong, 250021, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IVIEW-1201

Drug

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

Ofloxacin Eye Drops

Drug

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. Clearance Rate

    Time frame: Day 3, Day 6, Day 8±1, Day 14±1

    Bacterial clearance is defined as positive bacterial culture at baseline and negative bacterial culture at the last visit.

Sponsors and collaborators

Lead sponsor

IVIEW Therapeutics Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Apr 18, 2023
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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