Phase 2b Controlled Study of Dosing Techniques - Part B

iVIEW Therapeutics

Status and phase: Active, not recruiting; Phase 2

Conditions: Dry Eye

Treatments: Drug: IVW-1001 Ophthalmic Eyelid Wipe 0.4%; Drug: IVW-1001 Ophthalmic Eyelid Wipe 0.2%

Study type: Interventional

Funder types: Industry

Identifiers

NCT07161011

IVW-1001-CS-202B

Details and patient eligibility

About

Double-masked, dose-response of two concentrations of IVW-1001

Full description

Using the best dosing technique from Study NCT07140380, subjects will be randomized to one of two concentrations.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion:

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: Parallel Assignment

Masking: Quadruple Blind

---

30 participants in 2 patient groups

IVW-1001 0.2%

Experimental group

Description:

Ophthalmic Eyelid wipe

Treatment:

Drug: IVW-1001 Ophthalmic Eyelid Wipe 0.2%

IVW-1001 0.4%

Experimental group

Description:

Ophthalmic Eyelid Wipe

Treatment:

Drug: IVW-1001 Ophthalmic Eyelid Wipe 0.4%