NCT06400459

IVW-1001 Phase 1/2 in Subjects With Dry Eye Disease

Phase 1/2a, Proof-of-Concept, Multicenter, Parallel, Vehicle-Controlled, Double-Masked, Randomized Study Evaluating the Safety, Tolerability, and Efficacy of IVW-1001 Ophthalmic Eyelid Wipe in Subjects With Dry Eye Disease

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: IVIEW Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Double-masked, dose-response, trial of IVW-1001 in subjects with dry eye disease.

Detailed description

This is a randomized (1:1:1), multicenter, parallel, vehicle-controlled, double-masked study to evaluate the safety, tolerability, and efficacy of IVW-1001 Ophthalmic Eyelid Wipes in subjects with DED. Treatments will be IVW-1001 Ophthalmic Eyelid Wipe 0.2% (high dose), IVW 1001 0.1% (low dose), or IVW-1001 Ophthalmic Eyelid Wipe Placebo (vehicle). Subjects will participate in a 7-day, run-in period followed by a 28-daydosing period.

Conditions

• Dry Eye Disease

Interventions

Type	Name	Description
DRUG	IVW-1001 Ophthalmic Eyelid Wipe 0.1%	IVW-1001 Ophthalmic Eyelid Wipe 0.1%
DRUG	IVW-1001 Ophthalmic Eyelid Wipe 0.2%	IVW-1001 Ophthalmic Eyelid Wipe 0.2%
DRUG	IVW-1001 Placebo	IVW-1001 Placebo

Timeline

• Start date: 2024-06-25
• Primary completion: 2024-10-15
• Completion: 2024-10-15
• First posted: 2024-05-06
• Last updated: 2026-02-12
• Results posted: 2026-02-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study