Исследование офтальмологического раствора INV-102 у взрослых с умеренным симптоматическим синдромом сухого глаза

Part 1, Cohort 1: INV-102 ophthalmic solution 0.1% administered twice daily for 2 weeks

INV-102 Ophthalmic Solution

Part 1, Cohort 2: INV-102 ophthalmic solution 0.25% administered twice daily for 2 weeks

INV-102 Ophthalmic Solution

Part 1, Cohort 3: INV-102 ophthalmic solution 0.7% administered twice daily for 2 weeks

INV-102 Ophthalmic Solution

Part 1, Cohort 4: INV-102 ophthalmic solution 0.7% administered three times daily for 2 weeks

INV-102 Ophthalmic Solution

Part 2, Cohort 5: INV-102 ophthalmic solution administered for 2 weeks using a dose based on the results from Part 1, Cohorts 1 to 4

INV-102 Ophthalmic Solution

Part 1 (Cohorts 1-4) and Part 2 (Cohort 5): Vehicle ophthalmic solution administered two or three times daily (dependent on the cohort and the frequency of dosing of INV-102) for 2 weeks

Vehicle Ophthalmic Solution

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.

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.

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).