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

IVIEW Therapeutics Inc.150 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

150

Conditions

Dry Eye Disease

Interventions

IVW-1001 Ophthalmic Eyelid Wipe 0.1%DRUG

IVW-1001 Ophthalmic Eyelid Wipe 0.1%

IVW-1001 Ophthalmic Eyelid Wipe 0.2%DRUG

IVW-1001 Ophthalmic Eyelid Wipe 0.2%

IVW-1001 PlaceboDRUG

IVW-1001 Placebo

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Houston Eye Associates

Houston, Texas, United States

Outcomes

Primary Outcomes

Schirmer's

Mean change from baseline in study eye in unanesthetized measure of tear product using Schirmer strip (measured in mm of wetness)

Time frame: 29 Days

Secondary Outcomes

Visual Acuity

Mean change from baseline in best corrected visual acuity

Time frame: 29 Days

Total Corneal Fluorescein Staining Score in the Study Eye

Change from baseline in score on a scale (0 - none - to 20 - severe)

Time frame: Week 4

Symptom Assessment in Dry Eye (SANDE): Frequency of Symptoms Score

Change from Baseline in the SANDE visual analog scale (0 - none to 100 - severe)

Time frame: Week 4

Symptom Assessment in Dry Eye (SANDE): Severity of Symptoms Score

Change from baseline in the SANDE visual analog scale (0 - none to 100 - severe)

Time frame: 4 weeks

Symptom Assessment in Dry Eye (SANDE): Global Score

Change from baseline in the SANDE visual analog scale (0 - none to 100 - severe)

Time frame: 4 weeks

Data from ClinicalTrials.gov

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