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

Invirsa, Inc.84 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Dry Eye Disease

Interventions

INV-102DRUG

INV-102 Ophthalmic Solution

VehicleDRUG

Vehicle Ophthalmic Solution

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * Healthy male or female subject ≥18 years of age * Presence of moderate DED in at least one eye Key Exclusion Criteria: * 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

Locations (1)

iuvo BioScience

Rush, New York, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Day 15

Secondary Outcomes

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

The secondary endpoint in Part 2 of the study was change from Baseline to Day 15 in the Eye Dryness Composite Score in the study eye. The eye dryness composite score (points) combines the change from Baseline in eye dryness score from the DED symptom VAS and the change from Baseline in corneal fluorescein staining score. VAS eye dryness scores were rated by subjects on a scale of 0 (no discomfort) to 100 (maximal discomfort). Corneal fluorescein staining assessments were performed using the National Eye Institute/Industry grading scale to score each of 5 corneal zones on a 0 (no ocular surface disease) to 3 (severe ocular surface disease) scale (with a total score of 0 to 15). The calculated eye dryness composite score can range from -100 points to 100 points (positive values indicate worsening of dry eye disease signs and symptoms; negative values indicate improvement).

Time frame: Day 15

Data from ClinicalTrials.gov

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