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

Dry Eye Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06400459
• Other study ID #: IVW-1001-CS-101
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: July 1, 2024
• Est. completion date: July 1, 2025

Study information

• Verified date: May 2024
• Source: IVIEW Therapeutics Inc.
• Contact: Qi Zhu, MD
• Phone: (609) 773-8577
• Email: qzhu[@]iviewinc.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: July 1, 2025
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Drug:
• IVW-1001 Ophthalmic Eyelid Wipe 0.1%
IVW-1001 Ophthalmic Eyelid Wipe 0.1%
• IVW-1001 Ophthalmic Eyelid Wipe 0.2%
IVW-1001 Ophthalmic Eyelid Wipe 0.2%
• IVW-1001 Placebo
IVW-1001 Placebo

Locations

Country	Name	City	State
United States	Houston Eye Associates	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
IVIEW Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Schirmer's	Mean change from baseline in study eye in unanesthetized Schirmer	29 Days
Secondary	Visual acuity	Mean change from baseline in best corrected visual acuity	29 Days