Phase 2 Completed N=150 Randomized Quadruple-blind Treatment

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

Dry Eye Disease

Source: ClinicalTrials.gov NCT06400459 ↗

Enrolled (actual)

150

Serious AEs

0.0%

Results posted

Feb 2026

Primary outcomePrimary: Schirmer's — 1.3; 2.1; 0.9 mm

Summary

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Schirmer's	1.3; 2.1; 0.9	—
SECONDARY Visual Acuity	-0.007; -0.013; -0.014	—
SECONDARY Total Corneal Fluorescein Staining Score in the Study Eye	-1.65; -1.80; -1.10	—
SECONDARY Symptom Assessment in Dry Eye (SANDE): Frequency of Symptoms Score	-5.77; -23.57; -9.88	—
SECONDARY Symptom Assessment in Dry Eye (SANDE): Severity of Symptoms Score	-8.73; -22.80; -12.55	—
SECONDARY Symptom Assessment in Dry Eye (SANDE): Global Score	-7.11; -23.36; -11.16	—

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06400459). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.