IVW-1001 Phase 1/2 in Subjects With Dry Eye Disease

iVIEW Therapeutics

Status and phase: Completed; Phase 2; Phase 1

Conditions: Dry Eye Disease

Treatments: Drug: IVW-1001 Ophthalmic Eyelid Wipe 0.1%; Drug: IVW-1001 Ophthalmic Eyelid Wipe 0.2%; Drug: IVW-1001 Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06400459

IVW-1001-CS-101

Details and patient eligibility

About

Double-masked, dose-response, trial of IVW-1001 in subjects with dry eye disease.

Full description

This is a randomized (1:1:1), multicenter, parallel, vehicle-controlled, double-masked study to evaluate the safety, tolerability, and efficacy of IVW-1001 Ophthalmic Eyelid Wipes in subjects with DED. Treatments will be IVW-1001 Ophthalmic Eyelid Wipe 0.2% (high dose), IVW 1001 0.1% (low dose), or IVW-1001 Ophthalmic Eyelid Wipe Placebo (vehicle). Subjects will participate in a 7-day, run-in period followed by a 28-daydosing period.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subjects of any gender at least 18 years of age at the Screening Visit
2. Able to voluntarily provide written informed consent to participate in the study
3. Able and willing to comply with all study procedures and restrictions, follow study instructions, and complete required study visits
4. Diagnosis of Dry Eye Disease (DED)

Exclusion criteria

1. Corneal fluorescein staining score of 4 using the NEI grading system
2. Intraocular pressure ≥23 mmHg
3. History of glaucoma or ocular hypertension in either eye requiring past or current medical or surgical intervention
4. Subjects with ocular inflammatory conditions (eg, conjunctivitis, keratitis, severe anterior blepharitis, etc.) not related to DED

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 3 patient groups, including a placebo group

IVW-1001 0.1%

Experimental group

Description:

IVW-1001 Ophthalmic Eyelid Wipe 0.1%

Treatment:

Drug: IVW-1001 Ophthalmic Eyelid Wipe 0.1%

IVW-1001 0.2%

Experimental group

Description:

IVW-1001 Ophthalmic Eyelid Wipe 0.1%

Treatment:

Drug: IVW-1001 Ophthalmic Eyelid Wipe 0.2%

IVW-1001 Placebo

Placebo Comparator group

Description:

Vehicle

Treatment:

Drug: IVW-1001 Placebo