Trials Sponsors Conditions Drugs Pricing

Conditions

Acute Bacterial Conjunctivitis

Outcome Measures

Primary Outcomes (1)

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).

Secondary Outcomes (1)

Clearance Rate
Day 3, Day 6, Day 8±1, Day 14±1

Study Arms (2)

IVIEW-1201

EXPERIMENTAL

Drug: IVIEW-1201

Ofloxacin Eye Drops

ACTIVE COMPARATOR

Drug: Ofloxacin Eye Drops

Interventions

IVIEW-1201Drug

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

IVIEW-1201

Ofloxacin Eye DropsDrug

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

Ofloxacin Eye Drops

Eligibility Criteria

Age15 Years+

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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.

Sponsors & Collaborators

IVIEW Therapeutics Inc.
Industrylead

Study Sites (1)

Eye Hospital of Shandong First Medical University

Jinan, Shandong, 250021, China

Results Point of Contact

Title: Bo Liang, PhD
Organization: IVIEW Therapeutics Inc.

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Enrollment

129 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 29, 2023

First Posted

April 18, 2023

Study Start

January 5, 2023

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

IVIEW-1201

Ofloxacin Eye Drops

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Results Point of Contact

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

IVIEW-1201

Ofloxacin Eye Drops

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Results Point of Contact

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations