Phase 2b Controlled Study of Dosing Techniques

Not Applicable

Recruiting

• Conditions: Dry Eye Disease
• Interventions: Drug: IVW-1001 Ophthalmic Eyelid Wipe

• Registration Number: NCT07140380
• Lead Sponsor: IVIEW Therapeutics Inc.

Brief Summary

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

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 Timeline

• Status Verified: 2025-08
• Study Start: 2025-08-11
• Study First Submitted: 2025-08-18
• Study First Submitted QC: 2025-08-18
• Last Update Submitted: 2025-08-18
• Study First Posted: 2025-08-24
• Last Update Posted: 2025-08-24
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Method 1	IVW-1001 Ophthalmic Eyelid Wipe	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.
Method 2	IVW-1001 Ophthalmic Eyelid Wipe	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.
Method 3	IVW-1001 Ophthalmic Eyelid Wipe	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 .

Primary Outcome Measures

Name	Time	Method
Tear production	Day 8 for each treatment	Mean change from baseline in Unanesthetized Schirmer score

Secondary Outcome Measures

Name	Time	Method
Visual acuity	Day 8 for each treatment	Mean change from baseline in Best Corrected Visual Acuity

Trial Locations

Locations (1)

Eye Research Foundation; 🇺🇸 Newport Beach, California, United States