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

NCT06370039 | Completed Phase 2 FDA Drug

• 1 other identifier: INV-102-CS-003
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

Brief Summary

Phase 2 study to assess the efficacy of topically administered eyedrops of INV-102 during 4-week repeat dosing in subjects with moderate to severe dry eye disease.

Conditions

Dry Eye Disease

Keywords

Dry Eye; Keratoconjunctivitis sicca

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in corneal fluorescein staining total score on the National Eye Institute (NEI)/Industry scale

  Corneal fluorescein staining assessment will be performed using the NEI grading system to score each of 5 corneal zones (central, superior, lateral, medial, inferior) on a 0 to 3 scale (with a total score of 0 to 15). Higher scores indicate more corneal damage.

  Baseline to Day 29

Secondary Outcomes (1)

• Percentage of eyes with complete clearing of central corneal fluorescein staining

  Baseline to Day 29

Study Arms (2)

INV-102

EXPERIMENTAL

INV-102 0.7% ophthalmic solution administered for 4 weeks (twice daily \[BID\] for 2 weeks, then once daily \[QD\] for an additional 2 weeks)

Drug: INV-102

Vehicle

PLACEBO COMPARATOR

Vehicle ophthalmic solution administered for 4 weeks (BID for 2 weeks, then QD for an additional 2 weeks)

Drug: Vehicle

Interventions

INV-102 DRUG

INV-102 Ophthalmic Solution

INV-102

Vehicle DRUG

Vehicle Ophthalmic Solution

Vehicle

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects ≥18 and \<75 years of age
• Presence of moderate to severe dry eye disease (DED) in at least one eye

You may not qualify if:

• Presently using prescription eyedrops, except those used for dry eye disease, which must be discontinued 4 weeks prior
• Use of over-the-counter (OTC) eyedrops except for lubricant eyedrops or artificial tears, within 1 week prior to initiation of study drug dosing
• History or evidence of ocular infection within the previous 30 days
• Blepharitis or meibomian gland disease requiring the use of either topical or systemic antibiotics within 2 months
• Allergic conjunctivitis requiring treatment within 30 days
• Unable to discontinue contact lens wear for 2 weeks prior and for the duration of the study

Sponsors & Collaborators

• Invirsa, Inc.: lead

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

Study Officials

• Robert Shalwitz, MD

  Invirsa, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: April 12, 2024
• First Posted: April 17, 2024
• Study Start: March 27, 2024
• Primary Completion: July 3, 2024
• Study Completion: July 3, 2024
• Last Updated: July 2, 2025

Record last verified: 2025-06

Locations

US (1)