NCT07161011

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2025

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 8, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

September 8, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 3, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 3, 2025

Completed
Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

August 29, 2025

Last Update Submit

March 24, 2026

Conditions

Dry Eye

Keywords

Dry Eye

Outcome Measures

Primary Outcomes (1)

  • Unanesthetized Schirmer test

    Tear production

    7 days

Study Arms (2)

IVW-1001 0.2%

EXPERIMENTAL

Ophthalmic Eyelid wipe

Drug: IVW-1001 Ophthalmic Eyelid Wipe 0.2%

IVW-1001 0.4%

EXPERIMENTAL

Ophthalmic Eyelid Wipe

Drug: IVW-1001 Ophthalmic Eyelid Wipe 0.4%

Interventions

IVW-1001 Ophthalmic Eyelid Wipe 0.2%DRUG

Low dose

IVW-1001 0.2%
IVW-1001 Ophthalmic Eyelid Wipe 0.4%DRUG

High dose

IVW-1001 0.4%

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eye Research Foundation

Newport Beach, California, 92663, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Double-masked, randomized, parallel
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2025

First Posted

September 8, 2025

Study Start

September 8, 2025

Primary Completion

November 3, 2025

Study Completion

November 3, 2025

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)