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

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

Study Overview

• Status: Completed
• Conditions: Dry Eye Disease
• Intervention / Treatment: Drug: IVW-1001 Ophthalmic Eyelid Wipe 0.1%; Drug: IVW-1001 Ophthalmic Eyelid Wipe 0.2%; Drug: IVW-1001 Placebo

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 Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77025
      • Houston Eye Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IVW-1001 0.1%; IVW-1001 Ophthalmic Eyelid Wipe 0.1%	Drug: IVW-1001 Ophthalmic Eyelid Wipe 0.1%; IVW-1001 Ophthalmic Eyelid Wipe 0.1%
Experimental: IVW-1001 0.2%; IVW-1001 Ophthalmic Eyelid Wipe 0.1%	Drug: IVW-1001 Ophthalmic Eyelid Wipe 0.2%; IVW-1001 Ophthalmic Eyelid Wipe 0.2%
Placebo Comparator: IVW-1001 Placebo; Vehicle	Drug: IVW-1001 Placebo; IVW-1001 Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Schirmer's	Mean change from baseline in study eye in unanesthetized measure of tear product using Schirmer strip (measured in mm of wetness)	29 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Acuity	Mean change from baseline in best corrected visual acuity	29 Days
Total Corneal Fluorescein Staining Score in the Study Eye	Change from baseline in score on a scale (0 - none - to 20 - severe)	Week 4
Symptom Assessment in Dry Eye (SANDE): Frequency of Symptoms Score	Change from Baseline in the SANDE visual analog scale (0 - none to 100 - severe)	Week 4
Symptom Assessment in Dry Eye (SANDE): Severity of Symptoms Score	Change from baseline in the SANDE visual analog scale (0 - none to 100 - severe)	4 weeks
Symptom Assessment in Dry Eye (SANDE): Global Score	Change from baseline in the SANDE visual analog scale (0 - none to 100 - severe)	4 weeks

Collaborators and Investigators

• Sponsor: IVIEW Therapeutics Inc.
• Investigators: Study Director: Bo Liang, PhD, IVIEW Therapeutics Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2024
• Primary Completion (Actual): October 15, 2024
• Study Completion (Actual): October 15, 2024

Study Registration Dates

• First Submitted: May 1, 2024
• First Submitted That Met QC Criteria: May 1, 2024
• First Posted (Actual): May 6, 2024

Study Record Updates

• Last Update Posted (Actual): February 12, 2026
• Last Update Submitted That Met QC Criteria: January 25, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes
• Other Study ID Numbers: IVW-1001-CS-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No