Phase 2b Controlled Study of Dosing Techniques - Part B

Not Applicable

Active, not recruiting

• Conditions: Dry Eye
• Interventions: Drug: IVW-1001 Ophthalmic Eyelid Wipe 0.2%; Drug: IVW-1001 Ophthalmic Eyelid Wipe 0.4%

• Registration Number: NCT07161011
• Lead Sponsor: IVIEW Therapeutics Inc.

Brief Summary

Double-masked, dose-response of two concentrations of IVW-1001

Detailed Description

Using the best dosing technique from Study NCT07140380, subjects will be randomized to one of two concentrations.

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-29
• Study First Submitted QC: 2025-08-29
• Study Start: 2025-09-08
• Study First Posted: 2025-09-08
• Last Update Submitted: 2025-09-18
• Last Update Posted: 2025-09-23
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

• Corneal fluorescein staining score of 4 in either eye in any zone using the National Eye Institute grading system at either the Screening Visit or the Baseline Visit
• IOP ≥23 mmHg in either eye at either the Screening Visit or the Baseline Visit
• History of glaucoma or ocular hypertension in either eye requiring past or current medical or surgical intervention

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IVW-1001 0.2%	IVW-1001 Ophthalmic Eyelid Wipe 0.2%	Ophthalmic Eyelid wipe
IVW-1001 0.4%	IVW-1001 Ophthalmic Eyelid Wipe 0.4%	Ophthalmic Eyelid Wipe

Primary Outcome Measures

Name	Time	Method
Unanesthetized Schirmer test	7 days	Tear production

Trial Locations

Locations (1)

Eye Research Foundation; 🇺🇸 Newport Beach, California, United States