Status:
ACTIVE_NOT_RECRUITING
Phase 2b Controlled Study
Lead Sponsor:
IVIEW Therapeutics Inc.
Conditions:
Dry Eye Disease
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
Brief Summary
Double-masked two period controlled trial of three eyelid wipe dosing techniques
Detailed Description
This is a randomized, single center, single -masked study to evaluate the safety, tolerability, and efficacy of IVW-1001 Ophthalmic Eyelid Wipe dosing techniques in subjects with DED. Treatments will ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07140380
Start Date
August 20 2025
End Date
December 31 2025
Last Update
September 15 2025
Active Locations (1)
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1
Eye Research Foundation
Newport Beach, California, United States, 92663