IVW-1001 Phase 1/2 in Subjects With Dry Eye Disease

Phase 1/2a, Proof-of-Concept, Multicenter, Parallel, Vehicle-Controlled, Double-Masked, Randomized Study Evaluating the Safety, Tolerability, and Efficacy of IVW-1001 Ophthalmic Eyelid Wipe in Subjects With Dry Eye Disease

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06400459

Enrollment

150

Registered

2024-05-06

Start date

2024-06-25

Completion date

2024-10-15

Last updated

2026-02-12

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

Conditions

Dry Eye Disease

Brief summary

Double-masked, dose-response, trial of IVW-1001 in subjects with dry eye disease.

Detailed description

This is a randomized (1:1:1), multicenter, parallel, vehicle-controlled, double-masked study to evaluate the safety, tolerability, and efficacy of IVW-1001 Ophthalmic Eyelid Wipes in subjects with DED. Treatments will be IVW-1001 Ophthalmic Eyelid Wipe 0.2% (high dose), IVW 1001 0.1% (low dose), or IVW-1001 Ophthalmic Eyelid Wipe Placebo (vehicle). Subjects will participate in a 7-day, run-in period followed by a 28-daydosing period.

Interventions

DRUGIVW-1001 Ophthalmic Eyelid Wipe 0.1%

IVW-1001 Ophthalmic Eyelid Wipe 0.1%

DRUGIVW-1001 Ophthalmic Eyelid Wipe 0.2%

IVW-1001 Ophthalmic Eyelid Wipe 0.2%

DRUGIVW-1001 Placebo

IVW-1001 Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Double-masked

Intervention model description

Double-masked

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Subjects of any gender at least 18 years of age at the Screening Visit 2. Able to voluntarily provide written informed consent to participate in the study 3. Able and willing to comply with all study procedures and restrictions, follow study instructions, and complete required study visits 4. Diagnosis of Dry Eye Disease (DED)

Exclusion criteria

1. Corneal fluorescein staining score of 4 using the NEI grading system 2. Intraocular pressure ≥23 mmHg 3. History of glaucoma or ocular hypertension in either eye requiring past or current medical or surgical intervention 4. Subjects with ocular inflammatory conditions (eg, conjunctivitis, keratitis, severe anterior blepharitis, etc.) not related to DED

Design outcomes

Primary

Measure	Time frame	Description
Schirmer's	29 Days	Mean change from baseline in study eye in unanesthetized measure of tear product using Schirmer strip (measured in mm of wetness)

Secondary

Measure	Time frame	Description
Visual Acuity	29 Days	Mean change from baseline in best corrected visual acuity
Total Corneal Fluorescein Staining Score in the Study Eye	Week 4	Change from baseline in score on a scale (0 - none - to 20 - severe)
Symptom Assessment in Dry Eye (SANDE): Frequency of Symptoms Score	Week 4	Change from Baseline in the SANDE visual analog scale (0 - none to 100 - severe)
Symptom Assessment in Dry Eye (SANDE): Severity of Symptoms Score	4 weeks	Change from baseline in the SANDE visual analog scale (0 - none to 100 - severe)
Symptom Assessment in Dry Eye (SANDE): Global Score	4 weeks	Change from baseline in the SANDE visual analog scale (0 - none to 100 - severe)

Countries

United States

Contacts

STUDY_DIRECTORBo Liang, PhD

IVIEW Therapeutics Inc.

Baseline characteristics

Characteristic	—
Age, Continuous	63.5 years STANDARD_DEVIATION 12.07
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	2 Participants
Race (NIH/OMB) Black or African American	42 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	101 Participants
Region of Enrollment United States	150 Participants
Sex: Female, Male Female	113 Participants
Sex: Female, Male Male	10 Participants
Symptom Assessment in Dry Eye (SANDE): Frequency of Symptoms Score (0, none, to 100, severe)	61.1 Score on a scale STANDARD_DEVIATION 23.3
Symptom Assessment in Dry Eye (SANDE): Global Score	57.5 Score on a scale STANDARD_DEVIATION 22.1
Symptom Assessment in Dry Eye (SANDE): Severity of Symptoms Score	54.0 Score on a scale STANDARD_DEVIATION 20.2
Total Corneal Fluorescein Staining Score in the Study Eye (0, none to 20, severe)	6.5 Score on a scale STANDARD_DEVIATION 1.37
Unanesthetized Schirmer test (Study Eye)	6.5 mm STANDARD_DEVIATION 1.93

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 53	0 / 48	0 / 49
other Total, other adverse events	3 / 53	5 / 48	4 / 49
serious Total, serious adverse events	0 / 53	0 / 48	0 / 49

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026