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INV-102 0.7% Three times daily (TID) for Dry Eye Syndrome

Phase 1 & 2

Waitlist Available

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 through study completion (day 22)

Awards & highlights

Study Summary

This trial tests INV-102 eyedrops for safety & effectiveness in treating moderate dry eye disease over 2 weeks. Part 1 assesses safety & Part 2 assesses efficacy.

Eligible Conditions

Dry Eye Syndrome

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion (day 22)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion (day 22)

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion (day 22) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Part 1: Characterize the safety profile of INV-102

Part 2: Evaluate the efficacy of INV-102 in an expanded cohort

Secondary outcome measures

Part 2: Evaluate the efficacy of INV-102 using signs and symptoms in a combined outcome score

Trial Design

6Treatment groups

Experimental Treatment

Placebo Group

Group I: INV-102 TBD% BIDExperimental Treatment1 Intervention

Part 2, Cohort 5: INV-102 ophthalmic solution administered for 2 weeks using a dose based on the results from Part 1, Cohorts 1 to 4

Group II: INV-102 0.7% Three times daily (TID)Experimental Treatment1 Intervention

Part 1, Cohort 4: INV-102 ophthalmic solution 0.7% administered three times daily for 2 weeks

Group III: INV-102 0.7% BIDExperimental Treatment1 Intervention

Part 1, Cohort 3: INV-102 ophthalmic solution 0.7% administered twice daily for 2 weeks

Group IV: INV-102 0.25% BIDExperimental Treatment1 Intervention

Part 1, Cohort 2: INV-102 ophthalmic solution 0.25% administered twice daily for 2 weeks

Group V: INV-102 0.1% Twice daily (BID)Experimental Treatment1 Intervention

Part 1, Cohort 1: INV-102 ophthalmic solution 0.1% administered twice daily for 2 weeks

Group VI: VehiclePlacebo Group1 Intervention

Part 1 (Cohorts 1-4) and Part 2 (Cohort 5): Vehicle ophthalmic solution administered two or three times daily (dependent on the cohort and the frequency of dosing of INV-102) for 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

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Who is running the clinical trial?

Invirsa, Inc.Lead Sponsor

2 Previous Clinical Trials

212 Total Patients Enrolled

Biomedical Advanced Research and Development AuthorityFED

81 Previous Clinical Trials

909,357 Total Patients Enrolled

Robert Shalwitz, MDStudy ChairInvirsa, Inc.

1 Previous Clinical Trials

110 Total Patients Enrolled

Frequently Asked Questions

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

How many individuals are currently included in this clinical trial's patient cohort?

"Affirmative. According to clinicaltrials.gov, this medical trail is open for participants as of August 30th 2022 and was recently updated on October 14th 2022. 72 patients are being sought out by one healthcare facility for the study's duration."

Answered by AI

Is there an opportunity to enroll in this experiment at the present time?

"Data from clinicaltrials.gov indicates that this research study is actively seeking participants, with the trial having been posted on August 30th 2022 and updated as of October 14th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "Study of INV-102 Ophthalmic Solution in Adults With Moderate Symptomatic Dry Eye Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05586152.