Dry Eye
Conditions
Keywords
Dry Eye
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.
Interventions
Low dose
DRUGIVW-1001 Ophthalmic Eyelid Wipe 0.4%
High dose
Sponsors
IVIEW Therapeutics Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Double-masked, randomized, parallel
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Unanesthetized Schirmer test | 7 days | Tear production |
Countries
United States
Outcome results
None listed