drugset / Trial / NCT05586152
Study of INV-102 Ophthalmic Solution in Adults With Moderate Symptomatic Dry Eye Disease
Phase 1/2
Completed
84 enrolled
Invirsa, Inc.
Biomedical Advanced Research and Development Authority · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Phase 1/2, first-in-human, 2-part study to assess topically administered eyedrops of INV-102 during 2-week repeat dosing in subjects with moderate symptomatic dry eye disease. Part 1 will be a Dose Escalation phase across 4 cohorts of subjects to assess safety and tolerability of INV-102, and Part 2 will be an Optional Dose Expansion phase in a fifth cohort of subjects, pending the outcome of Part 1, to assess efficacy of INV-102 in the treatment of moderate symptomatic dry eye disease.
Timeline
- Start
- 2022-08-30
- Primary completion
- 2023-05-02
- Completion
- 2023-05-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | INV-102 | Unknown | 0.1 % | Topical |
| Subject | INV-102 | Unknown | 0.25 % | Topical |
| Subject | INV-102 | Unknown | 0.7 % | Topical |