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

NCT06370039 — Phase 2, Completed, 109 participants, Invirsa, Inc.

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT06370039
Status	Completed
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	109 (Actual)
Sponsor	Invirsa, Inc. (Industry); collaborators: Biomedical Advanced Research and Development Authority
Conditions	Dry Eye Disease
Interventions	INV-102, Vehicle (Drug)
Dates	start 2024-03-27, primary completion 2024-07-03, completion 2024-07-03, first posted 2024-04-17, last updated 2026-09-18
Locations	1 site in United States

-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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
INV-102	Experimental	Drug: INV-102	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)
Vehicle	Placebo comparator	Drug: Vehicle	Vehicle ophthalmic solution administered for 4 weeks (BID for 2 weeks, then QD for an additional 2 weeks)

INV-102 (Drug): INV-102 Ophthalmic Solution
Vehicle (Drug): Vehicle Ophthalmic Solution

+Outcome measures

Primary outcomes

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

Percentage of eyes with complete clearing of central corneal fluorescein staining [Baseline to Day 29]

+Eligibility

Sex: All, ages: 18 Years to 74 Years

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

+Locations (1)

Facility	City	Country	Status
iuvo BioScience	Rush, New York	United States

+Investigators

Robert Shalwitz, MD, Study chair, Invirsa, Inc.