Phase 2
N=150
IVW-1001 Phase 1/2 in Subjects With Dry Eye Disease
Dry Eye Disease
Bottom Line
View on ClinicalTrials.gov: NCT06400459 ↗Enrolled (actual)
150
Serious AEs
0.0%
Results posted
Feb 2026
Primary outcome: Primary: Schirmer's — 1.3; 2.1; 0.9 mm
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- IVW-1001 Ophthalmic Eyelid Wipe 0.1% (Drug); IVW-1001 Ophthalmic Eyelid Wipe 0.2% (Drug); IVW-1001 Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- IVIEW Therapeutics Inc.
- Primary completion
- Oct 2024
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 | — |
Summary
Double-masked, dose-response, trial of IVW-1001 in subjects with dry eye disease.
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
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.