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

NCT05586152 | Completed Phase 1 Results FDA Drug

• 1 other identifier: INV-102-CS-001
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dry Eye Disease

Keywords

Dry Eye; Keratoconjunctivitis sicca

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Part 2: Change From Baseline to Day 15 in the Eye Dryness Composite Score

  Day 15

Study Arms (6)

INV-102 0.1% Twice daily (BID)

EXPERIMENTAL

Part 1, Cohort 1: INV-102 ophthalmic solution 0.1% administered twice daily for 2 weeks

Drug: INV-102

INV-102 0.25% BID

EXPERIMENTAL

Part 1, Cohort 2: INV-102 ophthalmic solution 0.25% administered twice daily for 2 weeks

Drug: INV-102

INV-102 0.7% BID

EXPERIMENTAL

Part 1, Cohort 3: INV-102 ophthalmic solution 0.7% administered twice daily for 2 weeks

Drug: INV-102

INV-102 0.7% Three times daily (TID)

EXPERIMENTAL

Part 1, Cohort 4: INV-102 ophthalmic solution 0.7% administered three times daily for 2 weeks

Drug: INV-102

INV-102 TBD% BID

EXPERIMENTAL

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

Vehicle

PLACEBO COMPARATOR

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

Interventions

INV-102 DRUG

INV-102 Ophthalmic Solution

INV-102 0.1% Twice daily (BID); INV-102 0.25% BID; INV-102 0.7% BID; INV-102 0.7% Three times daily (TID); INV-102 TBD% BID

Vehicle DRUG

Vehicle Ophthalmic Solution

Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male or female subject ≥18 years of age
• Presence of moderate DED in at least one eye

You may not qualify if:

• 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

Sponsors & Collaborators

• Invirsa, Inc.: lead
• Biomedical Advanced Research and Development Authority: collaborator

Study Sites (1)

iuvo BioScience

Rush, New York, 14543, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes; Keratoconjunctivitis Sicca

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases

Results Point of Contact

• Title: Clinical Trials Information
• Organization: Invirsa, Inc.

info@invirsa.com

614-344-1765

Study Officials

• Robert Shalwitz, MD

  Invirsa, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2022
• First Posted: October 19, 2022
• Study Start: August 30, 2022
• Primary Completion: May 2, 2023
• Study Completion: May 2, 2023
• Last Updated: April 27, 2026
• Results First Posted: April 27, 2026

Record last verified: 2026-04

Locations

US (1)