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COMPLETED
NCT05586152
PHASE1/PHASE2

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

Sponsor: Invirsa, Inc.

View on ClinicalTrials.gov

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

DRUG

INV-102

INV-102 Ophthalmic Solution

DRUG

Vehicle

Vehicle Ophthalmic Solution

Locations (1)

iuvo BioScience

Rush, New York, United States