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.

Study Overview

• Status: Completed
• Conditions: Dry Eye Disease
• Intervention / Treatment: Drug: INV-102; Drug: Vehicle

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • Rush, New York, United States, 14543
      • iuvo BioScience

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: INV-102 0.25% BID; Part 1, Cohort 2: INV-102 ophthalmic solution 0.25% administered twice daily for 2 weeks	Drug: INV-102; INV-102 Ophthalmic Solution
Experimental: INV-102 0.7% BID; Part 1, Cohort 3: INV-102 ophthalmic solution 0.7% administered twice daily for 2 weeks	Drug: INV-102; INV-102 Ophthalmic Solution
Placebo Comparator: Vehicle; Part 1 (Cohorts 1-4) and Part 2 (Cohort 5): Vehicle ophthalmic solution administered two or three times daily (dependent on the cohort and the frequency of dosing of INV-102) for 2 weeks	Drug: Vehicle; Vehicle Ophthalmic Solution
Experimental: INV-102 TBD% BID; Part 2, Cohort 5: INV-102 ophthalmic solution administered for 2 weeks using a dose based on the results from Part 1, Cohorts 1 to 4	Drug: INV-102; INV-102 Ophthalmic Solution
Experimental: INV-102 0.1% Twice daily (BID); Part 1, Cohort 1: INV-102 ophthalmic solution 0.1% administered twice daily for 2 weeks	Drug: INV-102; INV-102 Ophthalmic Solution
Experimental: INV-102 0.7% Three times daily (TID); Part 1, Cohort 4: INV-102 ophthalmic solution 0.7% administered three times daily for 2 weeks	Drug: INV-102; INV-102 Ophthalmic Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1: Number of Subjects With At Least One (1) Treatment-Emergent Adverse Event	The primary endpoint in Part 1 of this First-in-Human (FIH) study was treatment-emergent adverse events (TEAEs) assessed across multiple dosing concentrations and dosing regimens.	From first dose through study completion (Day 22)
Part 2: Change From Baseline to Day 15 in the Eye Dryness Score From the Dry Eye Disease (DED) Symptom Visual Analog Scale (VAS)	The primary endpoint in Part 2 of the study was change from Baseline to Day 15 in the Eye Dryness Score in the study eye from the DED symptom VAS. The dry eye disease symptom visual analog scale consisted of various DED symptom parameters and was completed by subjects for each eye individually. Subjects were asked to rate their discomfort from 0 (no discomfort) to 100 (maximal discomfort) for each of the DED symptoms by placing a single vertical mark on a horizontal line based on the extent of their symptoms.	Day 15

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 2: Change From Baseline to Day 15 in the Eye Dryness Composite Score	The secondary endpoint in Part 2 of the study was change from Baseline to Day 15 in the Eye Dryness Composite Score in the study eye. The eye dryness composite score (points) combines the change from Baseline in eye dryness score from the DED symptom VAS and the change from Baseline in corneal fluorescein staining score. VAS eye dryness scores were rated by subjects on a scale of 0 (no discomfort) to 100 (maximal discomfort). Corneal fluorescein staining assessments were performed using the National Eye Institute/Industry grading scale to score each of 5 corneal zones on a 0 (no ocular surface disease) to 3 (severe ocular surface disease) scale (with a total score of 0 to 15). The calculated eye dryness composite score can range from -100 points to 100 points (positive values indicate worsening of dry eye disease signs and symptoms; negative values indicate improvement).	Day 15

Collaborators and Investigators

• Sponsor: Invirsa, Inc.
• Collaborators: Biomedical Advanced Research and Development Authority
• Investigators: Study Chair: Robert Shalwitz, MD, Invirsa, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2022
• Primary Completion (Actual): May 2, 2023
• Study Completion (Actual): May 2, 2023

Study Registration Dates

• First Submitted: September 19, 2022
• First Submitted That Met QC Criteria: October 14, 2022
• First Posted (Actual): October 19, 2022

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Dry Eye; Keratoconjunctivitis sicca
• Additional Relevant MeSH Terms: Eye Diseases; Corneal Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: INV-102-CS-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No