Acute Bacterial Conjunctivitis
Conditions
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
Interventions
DRUGIVIEW-1201
Four times per day for day 1-2 and three times per day for day 3-7
DRUGOfloxacin Eye Drops
Four times per day for day 1-2 and three times per day for day 3-7
Sponsors
IVIEW Therapeutics Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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. 2. Aged above 15 ( inclusive), male or female. 3. A diagnosis of acute bacterial conjunctivitis based on clinical observations: 1. a score of ≥1 for bulbar conjunctival congestion and ≥1 for conjunctival secretion/exudation in at least one eye (same eye); 2. increased purulent, mucopurulent or mucopurulent secretions are observed in the conjunctival sac of the affected eye in all patients. 4. Willing to cooperate in the completion of all procedures and visits required for the trial.
Exclusion criteria
1. 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). 2. 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; 3. Symptoms or signs of bacterial conjunctivitis for more than 72 hours prior to screening; 4. Suspected fungal, viral or acanthamoeba infections based on clinical observations; 5. Those with severe keratitis or corneal opacity affecting the study results; 6. Active inflammation of the cornea, iris, or anterior chamber; 7. Corrected visual acuity of less than 0.2 in either eye; 8. History of eye surgery within 3 months prior to screening; 9. Those who have a history of acute or chronic dacryocystitis; 10. Those who need to wear corneal contact lenses during the trial; 11. 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; 12. 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); 13. Those with co-infections requiring treatment with other anti-infective drugs in the study; 14. Those who are using other drugs that may interfere with the efficacy or safety evaluation of the drug; 15. Participation in other interventional clinical trials within 30 days prior to the study; 16. 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. 17. Other conditions or illnesses judged by the clinical investigator to be unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Cure Rate | 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
| Measure | Time frame | Description |
|---|---|---|
| Clearance Rate | 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. |
Countries
China
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 65 |
| 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. | 64 |
| Total | 129 |
Baseline characteristics
| Characteristic | IVIEW-1201 | Ofloxacin Eye Drops | Total |
|---|---|---|---|
| Age, Continuous | 57.60 Years STANDARD_DEVIATION 14.58 | 56.06 Years STANDARD_DEVIATION 13.83 | 56.84 Years STANDARD_DEVIATION 14.18 |
| Height | 163.43 cm STANDARD_DEVIATION 7.52 | 165.13 cm STANDARD_DEVIATION 8.1 | 164.27 cm STANDARD_DEVIATION 7.83 |
| Race/Ethnicity, Customized Ethnicity Han | 61 Participants | 62 Participants | 123 Participants |
| Race/Ethnicity, Customized Ethnicity Others | 4 Participants | 2 Participants | 6 Participants |
| Sex: Female, Male Female | 41 Participants | 36 Participants | 77 Participants |
| Sex: Female, Male Male | 24 Participants | 28 Participants | 52 Participants |
| Weight | 64.69 kg STANDARD_DEVIATION 11.07 | 64.68 kg STANDARD_DEVIATION 11.1 | 64.68 kg STANDARD_DEVIATION 11.04 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 64 | 0 / 64 |
| other Total, other adverse events | 11 / 64 | 0 / 64 |
| serious Total, serious adverse events | 1 / 64 | 0 / 64 |
Outcome results
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).
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).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IVIEW-1201 | Clinical Cure Rate | Clinically Cured | 37 Participants |
| IVIEW-1201 | Clinical Cure Rate | Not Clinically Cured | 27 Participants |
| Ofloxacin Eye Drops | Clinical Cure Rate | Clinically Cured | 31 Participants |
| Ofloxacin Eye Drops | Clinical Cure Rate | Not Clinically Cured | 33 Participants |
p-value: 0.0137Chi-squared
Secondary
Clearance Rate
Bacterial clearance is defined as positive bacterial culture at baseline and negative bacterial culture at the last visit.
Time frame: Day 3, Day 6, Day 8±1, Day 14±1
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| IVIEW-1201 | Clearance Rate | Day 14±1 | Cleared | 30 Participants |
| IVIEW-1201 | Clearance Rate | Day 6 | Not Cleared | 21 Participants |
| IVIEW-1201 | Clearance Rate | Day 3 | Not Cleared | 19 Participants |
| IVIEW-1201 | Clearance Rate | Day 8±1 | Cleared | 25 Participants |
| IVIEW-1201 | Clearance Rate | Day 3 | Cleared | 23 Participants |
| IVIEW-1201 | Clearance Rate | Day 6 | Cleared | 21 Participants |
| IVIEW-1201 | Clearance Rate | Day 14±1 | Not Cleared | 12 Participants |
| IVIEW-1201 | Clearance Rate | Day 8±1 | Not Cleared | 17 Participants |
| Ofloxacin Eye Drops | Clearance Rate | Day 14±1 | Not Cleared | 8 Participants |
| Ofloxacin Eye Drops | Clearance Rate | Day 8±1 | Not Cleared | 5 Participants |
| Ofloxacin Eye Drops | Clearance Rate | Day 3 | Cleared | 33 Participants |
| Ofloxacin Eye Drops | Clearance Rate | Day 3 | Not Cleared | 9 Participants |
| Ofloxacin Eye Drops | Clearance Rate | Day 6 | Cleared | 33 Participants |
| Ofloxacin Eye Drops | Clearance Rate | Day 6 | Not Cleared | 9 Participants |
| Ofloxacin Eye Drops | Clearance Rate | Day 8±1 | Cleared | 37 Participants |
| Ofloxacin Eye Drops | Clearance Rate | Day 14±1 | Cleared | 34 Participants |