Phase 2b Controlled Study

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07140380

Enrollment

Registered

2025-08-24

Start date

2025-08-20

Completion date

2025-10-08

Last updated

2026-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye Disease

Keywords

dry eye disease

Brief summary

Double-masked two period controlled trial of three eyelid wipe dosing techniques

Detailed description

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.

Interventions

DRUGIVW-1001 Ophthalmic Eyelid Wipe

Dry eye treatment

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Masking description

All site personnel will be aware of the assigned IVW-1001 Ophthalmic Eyelid Wipe 0.2% concentration. However, subjects will be randomized to the sequence of the assigned dosing technique procedures which will be provided to individual subjects by the unmasked dosing technique coordinator only

Intervention model description

Randomized cross-over to one of three dosing techniques with interperiod washout of 14 days.

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Tear production	Day 8 for each treatment	Mean change from baseline in Unanesthetized Schirmer score

Secondary

Measure	Time frame	Description
Visual acuity	Day 8 for each treatment	Mean change from baseline in Best Corrected Visual Acuity

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026