Phase 2b Controlled Study

IVIEW Therapeutics Inc.30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Dry Eye Disease

Interventions

IVW-1001 Ophthalmic Eyelid WipeDRUG

Dry eye treatment

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Locations (1)

Eye Research Foundation

Newport Beach, California, United States

Outcomes

Primary Outcomes

Tear production

Mean change from baseline in Unanesthetized Schirmer score

Time frame: Day 8 for each treatment

Secondary Outcomes

Visual acuity

Mean change from baseline in Best Corrected Visual Acuity

Time frame: Day 8 for each treatment

Data from ClinicalTrials.gov

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