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

NCT06400459 | Completed Phase 1 Results FDA Drug

• 1 other identifier: IVW-1001-CS-101
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dry Eye Disease

Outcome Measures

Primary Outcomes (1)

• Schirmer's

  Mean change from baseline in study eye in unanesthetized measure of tear product using Schirmer strip (measured in mm of wetness)

  29 Days

Secondary Outcomes (5)

• Visual Acuity

  29 Days

• Total Corneal Fluorescein Staining Score in the Study Eye

  Week 4

• Symptom Assessment in Dry Eye (SANDE): Frequency of Symptoms Score

  Week 4

• Symptom Assessment in Dry Eye (SANDE): Severity of Symptoms Score

  4 weeks

• Symptom Assessment in Dry Eye (SANDE): Global Score

  4 weeks

Study Arms (3)

IVW-1001 0.1%

EXPERIMENTAL

IVW-1001 Ophthalmic Eyelid Wipe 0.1%

Drug: IVW-1001 Ophthalmic Eyelid Wipe 0.1%

IVW-1001 0.2%

EXPERIMENTAL

IVW-1001 Ophthalmic Eyelid Wipe 0.1%

Drug: IVW-1001 Ophthalmic Eyelid Wipe 0.2%

IVW-1001 Placebo

PLACEBO COMPARATOR

Vehicle

Drug: IVW-1001 Placebo

Interventions

IVW-1001 Ophthalmic Eyelid Wipe 0.2% DRUG

IVW-1001 Ophthalmic Eyelid Wipe 0.2%

IVW-1001 0.2%

IVW-1001 Placebo DRUG

IVW-1001 Placebo

IVW-1001 Placebo

IVW-1001 Ophthalmic Eyelid Wipe 0.1% DRUG

IVW-1001 Ophthalmic Eyelid Wipe 0.1%

IVW-1001 0.1%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• IVIEW Therapeutics Inc.: lead

Study Sites (1)

Houston Eye Associates

Houston, Texas, 77025, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Bo Liang, PhD
• Organization: iView Therapeutics

info@iviewinc.com

609 773 8580

Study Officials

• Bo Liang, PhD

  IVIEW Therapeutics Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-masked
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double-masked

Study Record Dates

• First Submitted: May 1, 2024
• First Posted: May 6, 2024
• Study Start: June 25, 2024
• Primary Completion: October 15, 2024
• Study Completion: October 15, 2024
• Last Updated: February 12, 2026
• Results First Posted: February 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)