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INV-102 for Dry Eye Syndrome

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to day 29

Awards & highlights

Study Summary

This trial will test how well INV-102 eye drops work when used regularly for 4 weeks in people with moderate to severe dry eye disease.

Who is the study for?

This trial is for adults with moderate to severe dry eye disease. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and not have conditions that could interfere with the study's results.Check my eligibility

What is being tested?

The trial is testing INV-102 eyedrops against a placebo (vehicle) to see if they're effective in treating dry eye disease over a period of four weeks with repeated dosing.See study design

What are the potential side effects?

Potential side effects are not listed, but common ones for ophthalmic solutions may include temporary vision changes, discomfort or irritation in the eyes, redness, and possible allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to day 29

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to day 29

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to day 29 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Change from Baseline in corneal fluorescein staining total score on the National Eye Institute (NEI)/Industry scale

Secondary outcome measures

Percentage of eyes with complete clearing of central corneal fluorescein staining

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: INV-102Experimental Treatment1 Intervention

INV-102 0.7% ophthalmic solution administered for 4 weeks (twice daily [BID] for 2 weeks, then once daily [QD] for an additional 2 weeks)

Group II: VehiclePlacebo Group1 Intervention

Vehicle ophthalmic solution administered for 4 weeks (BID for 2 weeks, then QD for an additional 2 weeks)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

INV-102

2022

Completed Phase 2

~90

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Invirsa, Inc.Lead Sponsor

2 Previous Clinical Trials

186 Total Patients Enrolled

Robert Shalwitz, MDStudy ChairInvirsa, Inc.

1 Previous Clinical Trials

84 Total Patients Enrolled

Frequently Asked Questions

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

Are there any available vacancies for participants in this clinical trial?

"Indeed, information available on clinicaltrials.gov confirms the ongoing recruitment of participants for this research. The trial was first listed on March 27, 2024, with the most recent update made on April 12, 2024. A total of 110 individuals are sought to enroll from a single designated site."

Answered by AI

What is the current number of participants being enrolled in this research project?

"Indeed, as per clinicaltrials.gov, this ongoing trial is actively seeking participants. It was initially posted on March 27th, 2024 and last modified on April 12th, 2024. The recruitment target stands at 110 individuals from a single designated site."

Answered by AI

Are individuals older than 40 years of age eligible to participate in this study?

"To be eligible for this research project, individuals aged between 18 and 74 are sought after. It is worth mentioning that there are separate studies available for those under 18 years old (totaling 10) as well as individuals over the age of 65 (123 in total)."

Answered by AI

Which specific criteria must individuals meet in order to be considered eligible for participation in this clinical trial?

"Enrollment for this clinical investigation necessitates a diagnosis of dry eye syndrome and an age range from 18 to 74 years. The research aims to recruit 110 eligible individuals."

Answered by AI

Has the drug INV-102 been officially sanctioned by the FDA?

"As a Phase 2 trial, the safety of INV-102 has been rated as 2 by our team at Power. This indicates that while there is some existing safety data, efficacy data is still lacking."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of INV-102 Ophthalmic Solution in Adults With Moderate to Severe Dry Eye Disease

2024. "Study of INV-102 Ophthalmic Solution in Adults With Moderate to Severe Dry Eye Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06370039.

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