Skip to main content
OpenTrials
Completed

NCT Number: NCT07161011

Phase 2b Controlled Study of Dosing Techniques - Part B

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Eye Research Foundation

Newport Beach, California, 92663, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IVW-1001 Ophthalmic Eyelid Wipe 0.2%

Drug

Low dose

IVW-1001 Ophthalmic Eyelid Wipe 0.4%

Drug

High dose

Primary outcomes

  1. Unanesthetized Schirmer test

    Time frame: 7 days

    Tear production

Sponsors and collaborators

Lead sponsor

IVIEW Therapeutics Inc.

Industry

Registry information

Official study title

Phase 2b, Proof-of-Concept, Single-center, Double-Masked, Randomized Study Comparing the Safety, Tolerability, and Efficacy of Three Different Ophthalmic Eyelid Wipe Dosing Techniques Using IVW-1001 in Subjects With Dry Eye Disease

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 8, 2025
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.