Phase 2b Controlled Study of Dosing Techniques - Part B (NCT07161011) | Clinical Trial Compass
CompletedPhase 2
Phase 2b Controlled Study of Dosing Techniques - Part B
United States15 participantsStarted 2025-09-08
Plain-language summary
Double-masked, dose-response of two concentrations of IVW-1001
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 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