Trial Outcomes & Findings for Trial to Evaluate the Efficacy and Safety of IVIEW-1201 in Acute Bacterial Conjunctivitis (NCT NCT05816070)

Last Updated: 2025-12-02

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

129 participants

Primary outcome timeframe

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).

Results posted on

2025-12-02

Participant Flow

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.

Participant milestones

Participant milestones
Measure	IVIEW-1201 IVIEW-1201: Four times per day for day 1-2 and three times per day for day 3-7	Ofloxacin Eye Drops Ofloxacin Eye Drops: Four times per day for day 1-2 and three times per day for day 3-7
Overall Study STARTED	65	64
Overall Study COMPLETED	63	62
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IVIEW-1201 n=65 Participants 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.	Ofloxacin Eye Drops n=64 Participants 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.	Total n=129 Participants Total of all reporting groups
Age, Continuous	57.60 Years STANDARD_DEVIATION 14.58 • n=121 Participants	56.06 Years STANDARD_DEVIATION 13.83 • n=122 Participants	56.84 Years STANDARD_DEVIATION 14.18 • n=243 Participants
Sex: Female, Male Female	41 Participants n=121 Participants	36 Participants n=122 Participants	77 Participants n=243 Participants
Sex: Female, Male Male	24 Participants n=121 Participants	28 Participants n=122 Participants	52 Participants n=243 Participants
Race/Ethnicity, Customized Ethnicity · Han	61 Participants n=121 Participants	62 Participants n=122 Participants	123 Participants n=243 Participants
Race/Ethnicity, Customized Ethnicity · Others	4 Participants n=121 Participants	2 Participants n=122 Participants	6 Participants n=243 Participants
Height	163.43 cm STANDARD_DEVIATION 7.52 • n=121 Participants	165.13 cm STANDARD_DEVIATION 8.10 • n=122 Participants	164.27 cm STANDARD_DEVIATION 7.83 • n=243 Participants
Weight	64.69 kg STANDARD_DEVIATION 11.07 • n=121 Participants	64.68 kg STANDARD_DEVIATION 11.10 • n=122 Participants	64.68 kg STANDARD_DEVIATION 11.04 • n=243 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	IVIEW-1201 n=64 Participants 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.	Ofloxacin Eye Drops n=64 Participants 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.
Clinical Cure Rate Clinically Cured	37 Participants	31 Participants
Clinical Cure Rate Not Clinically Cured	27 Participants	33 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	IVIEW-1201 n=42 Participants 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.	Ofloxacin Eye Drops n=42 Participants 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.
Clearance Rate Day 3 · Cleared	23 Participants	33 Participants
Clearance Rate Day 3 · Not Cleared	19 Participants	9 Participants
Clearance Rate Day 6 · Cleared	21 Participants	33 Participants
Clearance Rate Day 6 · Not Cleared	21 Participants	9 Participants
Clearance Rate Day 8±1 · Cleared	25 Participants	37 Participants
Clearance Rate Day 8±1 · Not Cleared	17 Participants	5 Participants
Clearance Rate Day 14±1 · Cleared	30 Participants	34 Participants
Clearance Rate Day 14±1 · Not Cleared	12 Participants	8 Participants

Adverse Events

IVIEW-1201

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Ofloxacin Eye Drops

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	IVIEW-1201 n=64 participants at risk 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.	Ofloxacin Eye Drops n=64 participants at risk 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.
Infections and infestations Pneumonia infection	1.6% 1/64 • Number of events 1 • Through participants completion of the study, an average of 2 weeks.	0.00% 0/64 • Through participants completion of the study, an average of 2 weeks.

Other adverse events

Other adverse events
Measure	IVIEW-1201 n=64 participants at risk 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.	Ofloxacin Eye Drops n=64 participants at risk 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.
Eye disorders Eye Pain	17.2% 11/64 • Number of events 11 • Through participants completion of the study, an average of 2 weeks.	0.00% 0/64 • Through participants completion of the study, an average of 2 weeks.

Additional Information

Bo Liang, PhD

IVIEW Therapeutics Inc.

Phone: 609 773 8580

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER