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

Phase 1

Completed

• Conditions: Dry Eye Disease
• Interventions: Drug: IVW-1001 Ophthalmic Eyelid Wipe 0.1%; Drug: IVW-1001 Ophthalmic Eyelid Wipe 0.2%; Drug: IVW-1001 Placebo

• Registration Number: NCT06400459
• Lead Sponsor: IVIEW Therapeutics Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2024-05-01
• Study First Submitted QC: 2024-05-01
• Study First Posted: 2024-05-06
• Study Start: 2024-06-25
• Status Verified: 2024-10
• Primary Completion: 2024-10-15
• Study Completion: 2024-10-15
• Last Update Submitted: 2024-10-16
• Last Update Posted: 2024-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Subjects of any gender at least 18 years of age at the Screening Visit
2. Able to voluntarily provide written informed consent to participate in the study
3. Able and willing to comply with all study procedures and restrictions, follow study instructions, and complete required study visits
4. Diagnosis of Dry Eye Disease (DED)

Exclusion Criteria

1. Corneal fluorescein staining score of 4 using the NEI grading system
2. Intraocular pressure ≥23 mmHg
3. History of glaucoma or ocular hypertension in either eye requiring past or current medical or surgical intervention
4. Subjects with ocular inflammatory conditions (eg, conjunctivitis, keratitis, severe anterior blepharitis, etc.) not related to DED

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IVW-1001 0.1%	IVW-1001 Ophthalmic Eyelid Wipe 0.1%	IVW-1001 Ophthalmic Eyelid Wipe 0.1%
IVW-1001 0.2%	IVW-1001 Ophthalmic Eyelid Wipe 0.2%	IVW-1001 Ophthalmic Eyelid Wipe 0.1%
IVW-1001 Placebo	IVW-1001 Placebo	Vehicle

Primary Outcome Measures

Name	Time	Method
Schirmer's	29 Days	Mean change from baseline in study eye in unanesthetized Schirmer

Secondary Outcome Measures

Name	Time	Method
Visual acuity	29 Days	Mean change from baseline in best corrected visual acuity

Trial Locations

Locations (1)

Houston Eye Associates; 🇺🇸 Houston, Texas, United States