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Antiviral

INV-102 0.7% Three Times per Day (TID) for Pink Eye

Phase 2

Recruiting

Research Sponsored by Invirsa, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Do you have moderate to sever redness in your eye?

Are you experiencing some discharge in your infected eye?

Timeline

Screening 1 day

Treatment Varies

Follow Up 7 days

Awards & highlights

Study Summary

"This trial will test new eyedrops called INV-102 on people with Acute Infectious Keratoconjunctivitis. Participants will use the eyedrops for one week and then come back for a

Who is the study for?

Adults over 18 with moderate redness and at least mild discharge in one eye, diagnosed with Acute Infectious Keratoconjunctivitis (AIK), commonly known as pink eye. Participants should not have other conditions that would exclude them from the study.Check my eligibility

What is being tested?

The trial is testing INV-102 eyedrops against a placebo (vehicle) to see if they're effective for treating AIK. It's a phase 2 study where participants are randomly chosen to receive either the test medication or placebo for one week.See study design

What are the potential side effects?

Possible side effects of INV-102 may include irritation at the application site, increased tearing, itching, or redness. Since it's an ophthalmic solution, systemic side effects are less likely but can't be ruled out.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Timeline

Screening ~ 1 day4 visits

Treatment ~ Varies

Follow Up ~ 7 days1 visit

Screening ~ 1 day

Treatment ~ Varies

Follow Up ~7 days

This trial's timeline: 1 day for screening, Varies for treatment, and 7 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To Evaluate the Change in Combined Clinical Score

Secondary outcome measures

To Evaluate the Percent of participants requiring rescue

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: INV-102 0.7% Three Times per Day (TID)Experimental Treatment1 Intervention

INV-102 ophthalmic solution administered for about 1 week

Group II: Vehicle TIDPlacebo Group1 Intervention

INV-102 ophthalmic solution administered for about 1 week

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

INV-102

2022

Completed Phase 2

~90

0 / 3Eligibility criteria met

Find a Location

Logistics

Travel, including flights, are covered

Your expenses for travel tickets for this trial will be reimbursed.

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

Invirsa, Inc.Lead Sponsor

2 Previous Clinical Trials

194 Total Patients Enrolled

Biomedical Advanced Research and Development AuthorityFED

82 Previous Clinical Trials

909,655 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

At how many distinct sites is this clinical trial currently accessible?

"Currently, there are 9 active patient recruitments for this research endeavor. Some of the participating sites include Shettle Eye Research in Largo, Global Research Management in Glendale, and Quantum Clinical Trials in Miami Beach, among an additional 9 locations."

Answered by AI

Is this medical study currently accepting participants for enrollment?

"Indeed, data available on clinicaltrials.gov indicates that this investigation is currently open for participant recruitment. The study was initially posted on June 9th, 2023 and last revised on March 6th, 2024. A total of 102 individuals are sought after to take part in the research across nine distinct sites."

Answered by AI

What is the safety profile of INV-102 0.7% Three Times per Day (TID) in individuals?

"The safety evaluation of INV-102 0.7% Three Times per Day (TID) has been rated a 2 by our team at Power, as this trial falls under Phase 2. While there is existing safety data, efficacy evidence is yet to be established."

Answered by AI

What is the upper limit of patient enrollment for this research investigation?

"The successful execution of this research necessitates the recruitment of 102 eligible participants meeting the study's criteria. The trial will be overseen by Invirsa, Inc., with operations conducted at diverse locations such as Shettle Eye Research in Largo, Florida and Global Research Management in Glendale, California."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of INV-102 Ophthalmic Solution in Adults With Acute Infectious Keratoconjunctivitis

2023. "Study of INV-102 Ophthalmic Solution in Adults With Acute Infectious Keratoconjunctivitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05636228.