Study of INV-102 Ophthalmic Solution in Adults With Moderate Symptomatic Dry Eye Disease

• Status: Recruiting
• Trial end date: 2023-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Invirsa, Inc.
• Collaborator: Biomedical Advanced Research and Development Authority

Criteria

Key Inclusion Criteria:

• Healthy male or female subject ≥18 years of age

• Presence of moderate DED in at least one eye

Key Exclusion Criteria:

• Presently using prescription eyedrops, except those used for DED, which must be discontinued 2 weeks prior

• Use of OTC eyedrops except for lubricant eyedrops or artificial tears, within 1 week prior to initiation of study drug dosing

• External eye disease except primary DED

• Systemic disease associated with DED

• History or evidence of ocular infection within the previous 30 days

• History or evidence of ocular herpes simplex or ocular herpes zoster

• Blepharitis or meibomian gland disease requiring the use of either topical or systemic antibiotics within 2 months