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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INV-102 | Experimental | INV-102 0.7% ophthalmic solution administered for 4 weeks (twice daily [BID] for 2 weeks, then once daily [QD] for an additional 2 weeks) |
|
| Vehicle | Placebo Comparator | Vehicle ophthalmic solution administered for 4 weeks (BID for 2 weeks, then QD for an additional 2 weeks) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INV-102 | Drug | INV-102 Ophthalmic Solution |
| |
| Vehicle |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in corneal fluorescein staining total score on the National Eye Institute (NEI)/Industry scale | 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. | Baseline to Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of eyes with complete clearing of central corneal fluorescein staining | Baseline to Day 29 |
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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 | 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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| Drug |
Vehicle Ophthalmic Solution |
|
| D003229 |
| Conjunctival Diseases |
| D007634 | Keratitis |
| D003316 | Corneal Diseases |