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

Browse trials for

• Dry Eye Syndromes 1,292
• Keratoconjunctivitis Sicca 795

Keywords

• Dry Eye
• Keratoconjunctivitis sicca

Dry Eye Syndromes

1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.

This study's enrollment of 84 is above the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.

Lead sponsor

Invirsa, Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.

Eligibility criteria

Study arms

• Experimental
  INV-102 0.1% Twice daily (BID)

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

  Drug: INV-102

• Experimental
  INV-102 0.25% BID

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

  Drug: INV-102

• Experimental
  INV-102 0.7% BID

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

  Drug: INV-102

• Experimental
  INV-102 0.7% Three times daily (TID)

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

  Drug: INV-102

• Experimental
  INV-102 TBD% BID

  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

  Drug: INV-102

• Placebo comparator
  Vehicle

  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

  Drug: Vehicle

Interventions

• DrugINV-102

  INV-102 Ophthalmic Solution

• DrugVehicle

  Vehicle Ophthalmic Solution

Primary outcomes

1. 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)

2. 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

1. 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

Baseline characteristics

Study documents

• Study protocol · Feb 14, 2023
• Statistical analysis plan · Jun 13, 2023

Documents are hosted by the registry — open the source record to download them.