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

Phase 1/2, Multicenter, Randomized, Double-Masked, Vehicle-Controlled, Multiple Ascending Dose (Part 1) and Optional Dose Expansion (Part 2) Study of INV-102 Ophthalmic Solution in Adult Subjects With Moderate Symptomatic Dry Eye Disease

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.

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