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INV-102 0.1% Twice daily (BID) 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

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

85 Previous Clinical Trials

540,492 Total Patients Enrolled

Robert Shalwitz, MDStudy ChairInvirsa, Inc.

1 Previous Clinical Trials

110 Total Patients Enrolled

~30 spots leftby Jul 2025

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