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| Name | Class |
|---|---|
| Biomedical Advanced Research and Development Authority | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INV-102 0.1% Twice daily (BID) | Experimental | Part 1, Cohort 1: INV-102 ophthalmic solution 0.1% administered twice daily for 2 weeks |
|
| INV-102 0.25% BID | Experimental | Part 1, Cohort 2: INV-102 ophthalmic solution 0.25% administered twice daily for 2 weeks |
|
| INV-102 0.7% BID | Experimental | Part 1, Cohort 3: INV-102 ophthalmic solution 0.7% administered twice daily for 2 weeks |
|
| INV-102 0.7% Three times daily (TID) | Experimental | Part 1, Cohort 4: INV-102 ophthalmic solution 0.7% administered three times daily for 2 weeks |
|
| INV-102 TBD% BID | Experimental | 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 |
|
| Vehicle | Placebo Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INV-102 | Drug | INV-102 Ophthalmic Solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Shalwitz, MD | Invirsa, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| iuvo BioScience | Rush | New York | 14543 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1 0.1% INV-102 BID | Part 1, Cohort 1: 0.1% INV-102 ophthalmic solution administered twice daily for 2 weeks INV-102: INV-102 Ophthalmic Solution |
| FG001 | Part 1 0.25% INV-102 BID | Part 1, Cohort 2: 0.25% INV-102 ophthalmic solution administered twice daily for 2 weeks INV-102: INV-102 Ophthalmic Solution |
| FG002 | Part 1 0.7% INV-102 BID | Part 1, Cohort 3: 0.7% INV-102 ophthalmic solution administered twice daily for 2 weeks INV-102: INV-102 Ophthalmic Solution |
| FG003 | Part 1 0.7% INV-102 TID | Part 1, Cohort 4: 0.7% INV-102 ophthalmic solution administered three times daily for 2 weeks INV-102: INV-102 Ophthalmic Solution |
| FG004 | Part 1 Vehicle | Part 1 (Cohorts 1-4): 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: Vehicle Ophthalmic Solution |
| FG005 | Part 2 0.7% INV-102 BID | Part 2, Cohort 5: 0.7% INV-102 ophthalmic solution administered twice daily for 2 weeks (dose was based on the results from Part 1, Cohorts 1 to 4) INV-102: INV-102 Ophthalmic Solution |
| FG006 | Part 2 Vehicle | Part 2 (Cohort 5): Vehicle ophthalmic solution administered twice daily for 2 weeks Vehicle: Vehicle Ophthalmic Solution |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1 0.1% INV-102 BID | Part 1, Cohort 1: 0.1% INV-102 ophthalmic solution administered twice daily for 2 weeks INV-102: INV-102 Ophthalmic Solution |
| BG001 | Part 1 0.25% INV-102 BID |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Part 1 only. Safety population (all randomized subjects who received at least 1 drop of study drug.) | Posted | Count of Participants | Participants | No | From first dose through study completion (Day 22) |
|
From first dose through study completion (Day 22)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part 1 0.1% INV-102 BID | Part 1, Cohort 1: 0.1% INV-102 ophthalmic solution administered twice daily for 2 weeks INV-102: INV-102 Ophthalmic Solution |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye pain | Eye disorders | MedDRA 25.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Information | Invirsa, Inc. | 614-344-1765 | info@invirsa.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 14, 2023 | Apr 3, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 13, 2023 | Apr 3, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D007638 | Keratoconjunctivitis Sicca |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D007637 | Keratoconjunctivitis |
| D003231 | Conjunctivitis |
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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 | Drug | Vehicle Ophthalmic Solution |
|
| Day 15 |
Part 1, Cohort 2: 0.25% INV-102 ophthalmic solution administered twice daily for 2 weeks
INV-102: INV-102 Ophthalmic Solution
| BG002 | Part 1 0.7% INV-102 BID | Part 1, Cohort 3: 0.7% INV-102 ophthalmic solution administered twice daily for 2 weeks INV-102: INV-102 Ophthalmic Solution |
| BG003 | Part 1 0.7% INV-102 TID | Part 1, Cohort 4: 0.7% INV-102 ophthalmic solution administered three times daily for 2 weeks INV-102: INV-102 Ophthalmic Solution |
| BG004 | Part 1 Vehicle | Part 1 (Cohorts 1-4): 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: Vehicle Ophthalmic Solution |
| BG005 | Part 2 0.7% INV-102 BID | Part 2, Cohort 5: 0.7% INV-102 ophthalmic solution administered twice daily for 2 weeks (dose was based on the results from Part 1, Cohorts 1 to 4) INV-102: INV-102 Ophthalmic Solution |
| BG006 | Part 2 Vehicle | Part 2 (Cohort 5): Vehicle ophthalmic solution administered twice daily for 2 weeks Vehicle: Vehicle Ophthalmic Solution |
| BG007 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Part 1, Cohort 2: 0.25% INV-102 ophthalmic solution administered twice daily for 2 weeks
INV-102: INV-102 Ophthalmic Solution
| OG002 | Part 1 0.7% INV-102 BID | Part 1, Cohort 3: 0.7% INV-102 ophthalmic solution administered twice daily for 2 weeks INV-102: INV-102 Ophthalmic Solution |
| OG003 | Part 1 0.7% INV-102 TID | Part 1, Cohort 4: 0.7% INV-102 ophthalmic solution administered three times daily for 2 weeks INV-102: INV-102 Ophthalmic Solution |
| OG004 | Part 1 Vehicle | Part 1 (Cohorts 1-4): 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: Vehicle Ophthalmic Solution |
|
|
| Primary | 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. | Part 2 only (Part 1 primary endpoint was safety). Modified intent-to-treat (mITT) population (all randomized subjects who received at least 1 drop of study drug in the Study Eye and completed at least 1 post-dosing assessment in the Study Eye). Study Eye: eye with more severe corneal fluorescein staining (CFS). If both eyes had same CFS score, eye with the more severe eye dryness score from the DED symptom VAS. If both eyes had same eye dryness score, the right eye was the Study Eye. | Posted | Mean | Standard Deviation | score on a scale | Day 15 |
|
|
|
| Secondary | 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). | Part 2 only (Part 1 primary endpoint was safety). Modified intent-to-treat (mITT) population (all randomized subjects who received at least 1 drop of study drug in the Study Eye and completed at least 1 post-dosing assessment in the Study Eye). Study Eye: eye with more severe corneal fluorescein staining (CFS). If both eyes had same CFS score, eye with the more severe eye dryness score from the DED symptom VAS. If both eyes had same eye dryness score, the right eye was the Study Eye. | Posted | Mean | Standard Deviation | points | Day 15 |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 2 |
| 6 |
| EG001 | Part 1 0.25% INV-102 BID | Part 1, Cohort 2: 0.25% INV-102 ophthalmic solution administered twice daily for 2 weeks INV-102: INV-102 Ophthalmic Solution | 0 | 6 | 0 | 6 | 1 | 6 |
| EG002 | Part 1 0.7% INV-102 BID | Part 1, Cohort 3: 0.7% INV-102 ophthalmic solution administered twice daily for 2 weeks INV-102: INV-102 Ophthalmic Solution | 0 | 6 | 0 | 6 | 0 | 6 |
| EG003 | Part 1 0.7% INV-102 TID | Part 1, Cohort 4: 0.7% INV-102 ophthalmic solution administered three times daily for 2 weeks INV-102: INV-102 Ophthalmic Solution | 0 | 6 | 0 | 6 | 2 | 6 |
| EG004 | Part 1 Vehicle | Part 1 (Cohorts 1-4): 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: Vehicle Ophthalmic Solution | 0 | 12 | 0 | 12 | 1 | 12 |
| EG005 | Part 2 0.7% INV-102 BID | Part 2, Cohort 5: 0.7% INV-102 ophthalmic solution administered twice daily for 2 weeks (dose was based on the results from Part 1, Cohorts 1 to 4) INV-102: INV-102 Ophthalmic Solution | 0 | 32 | 0 | 32 | 0 | 32 |
| EG006 | Part 2 Vehicle | Part 2 (Cohort 5): Vehicle ophthalmic solution administered twice daily for 2 weeks Vehicle: Vehicle Ophthalmic Solution | 0 | 16 | 0 | 16 | 2 | 16 |
| Vision blurred | Eye disorders | MedDRA 25.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Conjunctival staining | Investigations | MedDRA 25.0 | Systematic Assessment |
|
| Vital dye staining cornea present | Investigations | MedDRA 25.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
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| Blepharitis | Eye disorders | MedDRA 25.0 | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA 25.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
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| D003229 |
| Conjunctival Diseases |
| D007634 | Keratitis |
| D003316 | Corneal Diseases |