INV-102 0.1% BID for Dry Eye Syndrome

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Dry Eye SyndromeINV-102 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

Phase 1/2, first-in-human, 2-part study to assess topically administered eyedrops of INV-102 during 2-week repeat dosing in subjects with moderate symptomatic dry eye disease. Part 1 will be a Dose Escalation phase across 4 cohorts of subjects to assess safety and tolerability of INV-102, and Part 2 will be an Optional Dose Expansion phase in a fifth cohort of subjects, pending the outcome of Part 1, to assess efficacy of INV-102 in the treatment of moderate symptomatic dry eye disease.

Eligible Conditions
  • Dry Eye Syndrome

Treatment Effectiveness

Study Objectives

2 Primary · 1 Secondary · Reporting Duration: Through study completion (Day 22)

Day 15
Part 2: Evaluate the efficacy of INV-102 in an expanded cohort
Part 2: Evaluate the efficacy of INV-102 using signs and symptoms in a combined outcome score
Day 22
Part 1: Characterize the safety profile of INV-102

Trial Safety

Trial Design

6 Treatment Groups

INV-102 0.1% BID
1 of 6
INV-102 0.7% TID
1 of 6
INV-102 TBD% BID
1 of 6
INV-102 0.7% BID
1 of 6
INV-102 0.25% BID
1 of 6
Vehicle
1 of 6

Experimental Treatment

Non-Treatment Group

72 Total Participants · 6 Treatment Groups

Primary Treatment: INV-102 0.1% BID · Has Placebo Group · Phase 1 & 2

INV-102 0.1% BID
Drug
Experimental Group · 1 Intervention: INV-102 · Intervention Types: Drug
INV-102 0.7% TID
Drug
Experimental Group · 1 Intervention: INV-102 · Intervention Types: Drug
INV-102 TBD% BID
Drug
Experimental Group · 1 Intervention: INV-102 · Intervention Types: Drug
INV-102 0.7% BID
Drug
Experimental Group · 1 Intervention: INV-102 · Intervention Types: Drug
INV-102 0.25% BID
Drug
Experimental Group · 1 Intervention: INV-102 · Intervention Types: Drug
Vehicle
Drug
PlaceboComparator Group · 1 Intervention: Vehicle · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion (day 22)

Who is running the clinical trial?

Biomedical Advanced Research and Development AuthorityFED
61 Previous Clinical Trials
100,763 Total Patients Enrolled
Invirsa, Inc.Lead Sponsor
1 Previous Clinical Trials
102 Total Patients Enrolled
Robert Shalwitz, MDStudy ChairInvirsa, Inc.

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a minimum age of 18 years.