Phase 2b Controlled Study

iVIEW Therapeutics

Status and phase: Active, not recruiting; Phase 2

Conditions: Dry Eye Disease

Treatments: Drug: IVW-1001 Ophthalmic Eyelid Wipe

Study type: Interventional

Funder types: Industry

Identifiers

NCT07140380

IVW-1001-CS-202

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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30 participants in 3 patient groups

IVW-1001 Ophthalmic Wipe - Method 1

Experimental group

Description:

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.

Treatment:

Drug: IVW-1001 Ophthalmic Eyelid Wipe

IVW-1001 Ophthalmic Wipe - Method 2

Experimental group

Description:

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.

Treatment:

Drug: IVW-1001 Ophthalmic Eyelid Wipe

IVW-1001 Ophthalmic Wipe - Method 3

Experimental group

Description:

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 .

Treatment:

Drug: IVW-1001 Ophthalmic Eyelid Wipe