NCT05586152

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Invirsa, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dry Eye Disease

Interventions

Type	Name	Description
DRUG	INV-102	INV-102 Ophthalmic Solution
DRUG	Vehicle	Vehicle Ophthalmic Solution

Timeline

• Start date: 2022-08-30
• Primary completion: 2023-05-02
• Completion: 2023-05-02
• First posted: 2022-10-19
• Last updated: 2024-04-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study