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Completed

NCT Number: NCT06370039

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

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.

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Key information

Conditions

Dry Eye Disease Conjunctival Diseases Conjunctivitis Corneal Diseases Dry Eye Syndromes Eye Diseases Keratitis Keratoconjunctivitis Keratoconjunctivitis Sicca Lacrimal Apparatus Diseases

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

iuvo BioScience

Rush, New York, 14543, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

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

Key Exclusion Criteria:

  • 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

Treatment and study plan

INV-102

Drug

INV-102 Ophthalmic Solution

Vehicle

Drug

Vehicle Ophthalmic Solution

Primary outcomes

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

    Time frame: Baseline to Day 29

    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.

Secondary outcomes

  1. Percentage of eyes with complete clearing of central corneal fluorescein staining

    Time frame: Baseline to Day 29

Sponsors and collaborators

Lead sponsor

Invirsa, Inc.

Industry

Registry information

Official study title

Phase 2, Multicenter, Randomized, Double-Masked, Vehicle-Controlled Study of INV-102 Ophthalmic Solution in Adult Subjects With Moderate to Severe Dry Eye Disease

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 17, 2024
Registry last updated
Jul 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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