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Study of INV-102 Ophthalmic Solution in Adults With Moderate Symptomatic Dry Eye Disease
Sponsor: Invirsa, Inc.
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.
Official title: Phase 1/2, Multicenter, Randomized, Double-Masked, Vehicle-Controlled, Multiple Ascending Dose (Part 1) and Optional Dose Expansion (Part 2) Study of INV-102 Ophthalmic Solution in Adult Subjects With Moderate Symptomatic Dry Eye Disease
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
84
Start Date
2022-08-30
Completion Date
2023-05-02
Last Updated
2026-09-18
Healthy Volunteers
No
Conditions
Interventions
INV-102
INV-102 Ophthalmic Solution
Vehicle
Vehicle Ophthalmic Solution
Locations (1)
iuvo BioScience
Rush, New York, United States