Phase 2b Controlled Study of Dosing Techniques - Part B

NCT ID: NCT07161011

Last Updated: 2025-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-08

Study Completion Date

2025-12-31

Brief Summary

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

Detailed Description

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

Conditions

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Dry Eye

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double-masked, randomized, parallel
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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IVW-1001 0.2%

Ophthalmic Eyelid wipe

Group Type EXPERIMENTAL

IVW-1001 Ophthalmic Eyelid Wipe 0.2%

Intervention Type DRUG

Low dose

IVW-1001 0.4%

Ophthalmic Eyelid Wipe

Group Type EXPERIMENTAL

IVW-1001 Ophthalmic Eyelid Wipe 0.4%

Intervention Type DRUG

High dose

Interventions

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IVW-1001 Ophthalmic Eyelid Wipe 0.2%

Low dose

Intervention Type DRUG

IVW-1001 Ophthalmic Eyelid Wipe 0.4%

High dose

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IVIEW Therapeutics Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Eye Research Foundation

Newport Beach, California, United States

Site Status

Countries

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United States

Other Identifiers

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IVW-1001-CS-202B

Identifier Type: -

Identifier Source: org_study_id

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