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

Dry Eye Disease

From 18 to 99 Years
+8 Eligibility Criteria

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: September 15, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: August 20, 2025Actual 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 
Principal SponsorIVIEW Therapeutics Inc.
Last updated: September 15, 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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants receive different treatments one after the other, switching from one to another during the study. This helps researchers understand how individuals respond to multiple treatments.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Participants do not know which treatment they are receiving, but researchers do. This helps prevent bias from participants' expectations while still allowing researchers to monitor the study closely.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 99 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Dry Eye Disease
Criteria
5 inclusion criteria required to participate
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

Show More Criteria

3 exclusion criteria prevent from participating
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

Mean change from baseline in Unanesthetized Schirmer score
Secondary Objectives

Mean change from baseline in Best Corrected Visual Acuity

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 FoundationNewport Beach, United StatesSee the location
SuspendedOne Study Center