Suspended

IVW-1001 Eyelid Wipe Techniques for Dry Eye Disease

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What is being tested

IVW-1001 Ophthalmic Eyelid Wipe

Drug
Who is being recruted

Eye Diseases

+ Lacrimal Apparatus Diseases

+ Dry Eye Syndromes

From 18 to 99 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: August 2025
See protocol details

Summary

Principal SponsorIVIEW Therapeutics Inc.
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Study start date: August 20, 2025

Actual date on which the first participant was enrolled.

This clinical trial is designed to test a new treatment for people suffering from Dry Eye Disease (DED), a condition that causes discomfort and irritation due to insufficient moisture on the eye's surface. The study aims to assess how safe and effective different doses of the IVW-1001 Ophthalmic Eyelid Wipe are. This research is significant because finding an effective treatment can improve eye comfort and quality of life for those affected by DED. Participants in the study will be divided into groups to receive either a low dose or a high dose of the medication, helping researchers understand if one dose is more beneficial than the other. Participants will use the eyelid wipes as part of their daily routine for a period of 50 days, followed by a 14-day break where they will not use the wipes. This structure allows the researchers to observe any changes in symptoms and determine how well the treatment works. The study is designed to ensure neither the participants nor the researchers know which dose each participant is receiving, which helps to reduce bias in the results. The goal is to gather clear, unbiased information about the safety and effectiveness of the eyelid wipe treatment for Dry Eye Disease.

Official TitlePhase 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 
NCT07140380
Principal SponsorIVIEW Therapeutics Inc.
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 99 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Eye DiseasesLacrimal Apparatus DiseasesDry Eye Syndromes

Criteria

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

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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.

Group II

Experimental
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.

Group III

Experimental
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 .

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Eye Research Foundation

Newport Beach, United StatesSee the location
SuspendedOne Study Center