Phase 2b Controlled Study

NCT07140380 | Completed Phase 2 FDA Drug

• 1 other identifier: IVW-1001-CS-202
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Double-masked two period controlled trial of three eyelid wipe dosing techniques

Conditions

Dry Eye Disease

Keywords

dry eye disease

Outcome Measures

Primary Outcomes (1)

• Tear production

  Mean change from baseline in Unanesthetized Schirmer score

  Day 8 for each treatment

Secondary Outcomes (1)

• Visual acuity

  Day 8 for each treatment

Study Arms (3)

IVW-1001 Ophthalmic Wipe - Method 1

EXPERIMENTAL

With eyes completely closed, the subject should wipe upper eyelid in a nasal to temporal direction with the IVW-1001 Ophthalmic Eyelid Wipe while applying moderate pressure to the eyelid skin slightly away from the eyelash line.

Drug: IVW-1001 Ophthalmic Eyelid Wipe

IVW-1001 Ophthalmic Wipe - Method 2

EXPERIMENTAL

With eyes completely closed, the subject should wipe the upper eyelid in a nasal to temporal direction with the IVW-1001 Ophthalmic Eyelid Wipe while applying moderate pressure directly at the lash margin covering the eyelash line.

Drug: IVW-1001 Ophthalmic Eyelid Wipe

IVW-1001 Ophthalmic Wipe - Method 3

EXPERIMENTAL

With eyes completely closed, the subject should lay the IVW-1001 Ophthalmic Eyelid Wipe on the upper eyelid for 5 seconds, especially over the lash margin covering the eyelash line, then wiping the upper eyelid in a nasal to temporal direction. while applying moderate pressure directly at the lash margin covering the eyelash line .

Drug: IVW-1001 Ophthalmic Eyelid Wipe

Interventions

IVW-1001 Ophthalmic Eyelid Wipe DRUG

Dry eye treatment

IVW-1001 Ophthalmic Wipe - Method 1; IVW-1001 Ophthalmic Wipe - Method 2; IVW-1001 Ophthalmic Wipe - Method 3

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Self-reported diagnosis of DED in one or both eyes
• BCVA +0.70 logarithm of minimum angle of refraction (Snellen equivalent 20/100) or better in each eye at the Screening Visit
• For women of childbearing potential, confirmed negative pregnancy test at the Screening Visit, not nursing a child, and willing to comply with one of the acceptable methods of birth control described in the protocol
• History (by subject recollection) of artificial tear use within 30 days prior to the Screening Visit
• Unanesthetized Schirmer's test score 5-19 mm inclusive in at least 1 eye (same eye) at the Screening Visit and the Baseline Visit

You may not qualify if:

• 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

Sponsors & Collaborators

• IVIEW Therapeutics Inc.: lead

Study Sites (1)

Eye Research Foundation

Newport Beach, California, 92663, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All site personnel will be aware of the assigned IVW-1001 Ophthalmic Eyelid Wipe 0.2% concentration. However, subjects will be randomized to the sequence of the assigned dosing technique procedures which will be provided to individual subjects by the unmasked dosing technique coordinator only
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized cross-over to one of three dosing techniques with interperiod washout of 14 days.

Study Record Dates

• First Submitted: August 18, 2025
• First Posted: August 24, 2025
• Study Start: August 20, 2025
• Primary Completion: October 8, 2025
• Study Completion: October 8, 2025
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)