Phase 2 N=84 Randomized Quadruple-blind Treatment

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

Dry Eye Disease

Bottom Line

View on ClinicalTrials.gov: NCT05586152 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2026

Primary outcome: Primary: Part 1: Number of Subjects With At Least One (1) Treatment-Emergent Adverse Event — 2; 1; 0; 2 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: INV-102 (Drug); Vehicle (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Invirsa, Inc.
Primary completion: May 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Part 1: Number of Subjects With At Least One (1) Treatment-Emergent Adverse Event	2; 1; 0; 2; 1	—
PRIMARY Part 2: Change From Baseline to Day 15 in the Eye Dryness Score From the Dry Eye Disease (DED) Symptom Visual Analog Scale (VAS)	-15.50; -21.20	—
SECONDARY Part 2: Change From Baseline to Day 15 in the Eye Dryness Composite Score	-10.458; -13.267	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05586152). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.