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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IVIEW-1201 | Experimental |
| |
| Ofloxacin Eye Drops | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IVIEW-1201 | Drug | Four times per day for day 1-2 and three times per day for day 3-7 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Clearance Rate | Bacterial clearance is defined as positive bacterial culture at baseline and negative bacterial culture at the last visit. | Day 3, Day 6, Day 8±1, Day 14±1 |
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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:
Willing to cooperate in the completion of all procedures and visits required for the trial.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye Hospital of Shandong First Medical University | Jinan | Shandong | 250021 | China |
All sites recruited participants simultaneously. They might have the same/ very close enrollment dates. So the final enrollments (129 participants) exceeded the proposed number (120 participatns in protocol) because a couple of participants were enrolled at similar time when approaching to the end of enrollment.
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| ID | Title | Description |
|---|---|---|
| FG000 | IVIEW-1201 | IVIEW-1201: Four times per day for day 1-2 and three times per day for day 3-7 |
| FG001 | Ofloxacin Eye Drops | Ofloxacin Eye Drops: Four times per day for day 1-2 and three times per day for day 3-7 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | IVIEW-1201 | Administed once at the study site, and then at least 3 hours apart until bedtime, with a maximum of 4 doses on D1; 4 times on D2 at least 3 hours apart; 3 times a day at least 3 hours apart from D3 to D7. The duration of treatment is 7 days. |
| BG001 | Ofloxacin Eye Drops |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Count of Participants | Participants | 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). |
|
Through participants completion of the study, an average of 2 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IVIEW-1201 | Administed once at the study site, and then at least 3 hours apart until bedtime, with a maximum of 4 doses on D1; 4 times on D2 at least 3 hours apart; 3 times a day at least 3 hours apart from D3 to D7. The duration of treatment is 7 days. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia infection | Infections and infestations | Non-systematic Assessment | The subject was diagnosed with pneumonia [a Grade 3 AE leading to hospitalization (outcome: resolved), but not related to the investigational drug] and did not withdraw from the trial due to the SAE. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye Pain | Eye disorders | Non-systematic Assessment | In the study, all the AEs with an incidence ≥ 5% were eye pain and occurred in the treatment group |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bo Liang, PhD | IVIEW Therapeutics Inc. | 609 773 8580 | info@iviewinc.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 10, 2022 | May 13, 2025 | Prot_SAP_000.pdf |
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| Ofloxacin Eye Drops |
| Drug |
Four times per day for day 1-2 and three times per day for day 3-7 |
|
Administed once at the study site, and then at least 3 hours apart until bedtime, with a maximum of 4 doses on D1; 4 times on D2 at least 3 hours apart; 3 times a day at least 3 hours apart from D3 to D7. The duration of treatment is 7 days. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
| Ofloxacin Eye Drops |
Administed once at the study site, and then at least 3 hours apart until bedtime, with a maximum of 4 doses on D1; 4 times on D2 at least 3 hours apart; 3 times a day at least 3 hours apart from D3 to D7. The duration of treatment is 7 days. |
|
|
|
| Secondary | Clearance Rate | Bacterial clearance is defined as positive bacterial culture at baseline and negative bacterial culture at the last visit. | Posted | Count of Participants | Participants | Day 3, Day 6, Day 8±1, Day 14±1 |
|
|
|
| 0 |
| 64 |
| 1 |
| 64 |
| 11 |
| 64 |
| EG001 | Ofloxacin Eye Drops | Administed once at the study site, and then at least 3 hours apart until bedtime, with a maximum of 4 doses on D1; 4 times on D2 at least 3 hours apart; 3 times a day at least 3 hours apart from D3 to D7. The duration of treatment is 7 days. | 0 | 64 | 0 | 64 | 0 | 64 |
|
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The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results.
| Day 6 |
|
| Day 8±1 |
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| Day 14±1 |
|