Acute Bacterial ConjunctivitisPhase 2NCT05816070

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

A Phase 2 study testing IVIEW-1201 and Ofloxacin Eye Drops in people with Acute Bacterial Conjunctivitis, run by IVIEW Therapeutics Inc. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 15 years and older
Conditions the study is for: Acute Bacterial Conjunctivitis
What is being tested?: IVIEW-1201 and Ofloxacin Eye Drops
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 129 participants
Where: 1 siteChina
Study dates: 5 Jan 2023to 12 Oct 2024
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 15 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

Show all 17Show fewer

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.

Trial locations and contacts

1 site in 1 country.

China1 site

Eye Hospital of Shandong First Medical University
Jinan, Shandong, 250021

Other trials in China

About this study

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

Conditions: Acute Bacterial Conjunctivitis
Being tested: IVIEW-1201, Ofloxacin Eye Drops

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IVIEW-1201Drug
Four times per day for day 1-2 and three times per day for day 3-7
Ofloxacin Eye DropsDrug
Four times per day for day 1-2 and three times per day for day 3-7

Study groups in NCT05816070
Study group	Role	What they receive
IVIEW-1201	Experimental	Not described Receives: Drug: IVIEW-1201
Ofloxacin Eye Drops	Active comparator	Not described Receives: Drug: Ofloxacin Eye Drops

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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
Bacterial clearance is defined as positive bacterial culture at baseline and negative bacterial culture at the last visit.
Measured: Day 3, Day 6, Day 8±1, Day 14±1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Jan 202312 Oct 2024

First posted18 Apr 2023
Study start5 Jan 2023
Primary completion13 Nov 2023
Study completion12 Oct 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Acute Bacterial ConjunctivitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 129 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05816070
Sponsor's protocol ID: IVIEW-1201-BAC-II
Status last verified: Nov 2025
First submitted: 29 Mar 2023
Last updated: 2 Dec 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05816070
Acronym / sponsor ID: IVIEW-1201-BAC-II
Conditions: Acute Bacterial Conjunctivitis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 129 participants (actual)
Lead sponsor: IVIEW Therapeutics Inc.Industry (pharma, biotech, devices)
Study start: 5 Jan 2023 (actual)
Primary completion: 13 Nov 2023 (actual)
Study completion: 12 Oct 2024 (actual)
First posted: 18 Apr 2023 (actual)
Results: Posted 15 Jun 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
IVIEW-1201	Experimental	Drug: IVIEW-1201
Ofloxacin Eye Drops	Active comparator	Drug: Ofloxacin Eye Drops

Who may qualify

Ages: 15 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (6 listed)

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:
Willing to cooperate in the completion of all procedures and visits required for the trial.

Key exclusion criteria (17 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
IVIEW-1201Four times per day for day 1-2 and three times per day for day 3-7	Drug	IVIEW-1201
Ofloxacin Eye DropsFour times per day for day 1-2 and three times per day for day 3-7	Drug	Ofloxacin Eye Drops

Primary outcome

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).

1 secondary outcome

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

Results and safety

Results posted to the registry on 15 Jun 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
IVIEW-1201	65	63
Ofloxacin Eye Drops	64	62

Primary outcome: 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).. Count of participants. Unit: Participants

Measure	IVIEW-1201 n = 64	Ofloxacin Eye Drops n = 64
Clinically Cured	37	31
Not Clinically Cured	27	33

IVIEW-1201 vs Ofloxacin Eye Drops: p = 0.0137, Chi-squared

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Through participants completion of the study, an average of 2 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
IVIEW-1201	1 of 64 (1.6%)	11 of 64 (17.2%)	0 of 64
Ofloxacin Eye Drops	0 of 64 (0%)	0 of 64 (0%)	0 of 64

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing IVIEW-1201 and Ofloxacin Eye Drops in people with Acute Bacterial Conjunctivitis, run by IVIEW Therapeutics Inc. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05816070.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.