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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06370039

Enrollment

109

Registered

2024-04-17

Start date

2024-03-27

Completion date

2024-07-03

Last updated

2025-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye Disease

Keywords

Dry Eye, Keratoconjunctivitis sicca

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.

Interventions

DRUGINV-102

INV-102 Ophthalmic Solution

DRUGVehicle

Vehicle Ophthalmic Solution

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 74 Years

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
Percentage of eyes with complete clearing of central corneal fluorescein staining	Baseline to Day 29

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026