Phase 2b Controlled Study

Phase 2b, Proof-of-Concept, Single-center, Double-Masked, Randomized Study Comparing the Safety, Tolerability, and Efficacy of Three Different Ophthalmic Eyelid Wipe Dosing Techniques Using IVW-1001 in Subjects With Dry Eye Disease

Double-masked two period controlled trial of three eyelid wipe dosing techniques

Study Overview

• Status: Completed
• Conditions: Dry Eye Disease
• Intervention / Treatment: Drug: IVW-1001 Ophthalmic Eyelid Wipe

Detailed Description

This is a randomized, single center, single -masked study to evaluate the safety, tolerability, and efficacy of IVW-1001 Ophthalmic Eyelid Wipe dosing techniques in subjects with DED. Treatments will be IVW 1001 Ophthalmic Eyelid Wipe 0.2% (low dose) and 0.4% (high dose). Subjects will participate in a 50-day, double -masked three dosing technique comparisons period using IVW-1001 Ophthalmic Eyelid Wipe 0.2% followed by a 14-day between period washout.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Newport Beach, California, United States, 92663
      • Eye Research Foundation

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Self-reported diagnosis of DED in one or both eyes
• BCVA +0.70 logarithm of minimum angle of refraction (Snellen equivalent 20/100) or better in each eye at the Screening Visit
• For women of childbearing potential, confirmed negative pregnancy test at the Screening Visit, not nursing a child, and willing to comply with one of the acceptable methods of birth control described in the protocol
• History (by subject recollection) of artificial tear use within 30 days prior to the Screening Visit
• Unanesthetized Schirmer's test score 5-19 mm inclusive in at least 1 eye (same eye) at the Screening Visit and the Baseline Visit

Exclusion Criteria:

• Corneal fluorescein staining score of 4 in either eye in any zone using the National Eye Institute grading system at either the Screening Visit or the Baseline Visit
• IOP ≥23 mmHg in either eye at either the Screening Visit or the Baseline Visit
• History of glaucoma or ocular hypertension in either eye requiring past or current medical or surgical intervention

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IVW-1001 Ophthalmic Wipe - Method 1; With eyes completely closed, the subject should wipe upper eyelid in a nasal to temporal direction with the IVW-1001 Ophthalmic Eyelid Wipe while applying moderate pressure to the eyelid skin slightly away from the eyelash line.	Drug: IVW-1001 Ophthalmic Eyelid Wipe; Dry eye treatment
Experimental: IVW-1001 Ophthalmic Wipe - Method 2; With eyes completely closed, the subject should wipe the upper eyelid in a nasal to temporal direction with the IVW-1001 Ophthalmic Eyelid Wipe while applying moderate pressure directly at the lash margin covering the eyelash line.	Drug: IVW-1001 Ophthalmic Eyelid Wipe; Dry eye treatment
Experimental: IVW-1001 Ophthalmic Wipe - Method 3; With eyes completely closed, the subject should lay the IVW-1001 Ophthalmic Eyelid Wipe on the upper eyelid for 5 seconds, especially over the lash margin covering the eyelash line, then wiping the upper eyelid in a nasal to temporal direction. while applying moderate pressure directly at the lash margin covering the eyelash line .	Drug: IVW-1001 Ophthalmic Eyelid Wipe; Dry eye treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tear production	Mean change from baseline in Unanesthetized Schirmer score	Day 8 for each treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual acuity	Mean change from baseline in Best Corrected Visual Acuity	Day 8 for each treatment

Collaborators and Investigators

• Sponsor: IVIEW Therapeutics Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2025
• Primary Completion (Actual): October 8, 2025
• Study Completion (Actual): October 8, 2025

Study Registration Dates

• First Submitted: August 18, 2025
• First Submitted That Met QC Criteria: August 18, 2025
• First Posted (Actual): August 24, 2025

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: dry eye disease
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes
• Other Study ID Numbers: IVW-1001-CS-202

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
• product manufactured in and exported from the U.S.: No