At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating INV-102 and Vehicle for Dry Eye Disease. Completed, enrolled 84 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
INV-102 Ophthalmic Solution
Vehicle Ophthalmic Solution