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
| Registry | NCT07140380 |
|---|---|
| Status | Completed |
| Phase | Phase 2 |
| Study type | Interventional; randomized, crossover, masking: single, treatment |
| Enrollment | 30 (Actual) |
| Sponsor | IVIEW Therapeutics Inc. (Industry) |
| Conditions | Dry Eye Disease |
| Interventions | IVW-1001 Ophthalmic Eyelid Wipe (Drug) |
| Dates | start 2025-08-20, primary completion 2025-10-08, completion 2025-10-08, first posted 2025-08-24, last updated 2026-03-27 |
| Locations | 1 site in United States |
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All trials for Dry Eye Disease All trials of IVW-1001 Ophthalmic Eyelid Wipe
Double-masked two period controlled trial of three eyelid wipe dosing techniques
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| IVW-1001 Ophthalmic Wipe - Method 1 | Experimental | Drug: 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. |
| IVW-1001 Ophthalmic Wipe - Method 2 | Experimental | Drug: 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. |
| IVW-1001 Ophthalmic Wipe - Method 3 | Experimental | Drug: 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 . |
Sex: All, ages: 18 Years to 99 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| Eye Research Foundation | Newport Beach, California | United States |