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| Name | Class |
|---|---|
| Biomedical Advanced Research and Development Authority | FED |
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Phase 2, randomized study to assess topically administered eyedrops of INV-102 compared to vehicle during 1-week dosing in participants with Acute Infectious Keratoconjunctivitis (AIK). Participants will return for a follow up visit 1 week after end of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INV-102 0.7% Three Times per Day (TID) | Experimental | INV-102 ophthalmic solution administered for about 1 week |
|
| Vehicle TID | Placebo Comparator | INV-102 ophthalmic solution administered for about 1 week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INV-102 | Drug | INV-102 Ophthalmic Solution |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To Evaluate the Change in Combined Clinical Score | To evaluate the efficacy of INV-102 compared to vehicle control in reducing Combined Clinical Score (bulbar hyperemia plus conjunctival discharge) in patients with AIK. Conjunctival hyperemia will be rated by using the modified version of Cornea and Contact Lens Research Unit grading scale for bulbar redness, which ranges from 0 (none) to 4 points (very severe). Conjunctival discharge will be assessed using the chart below from Schwab and Friedlander (2002) to score conjunctival discharge from 0 (absent/normal) to 3 (severe). | Through End of Treatment (Day 8) |
| Measure | Description | Time Frame |
|---|---|---|
| To Evaluate the Percent of participants requiring rescue | To evaluate the percent of patients requiring rescue therapy from Day 3 in the INV-102 arm compared to vehicle control | Day 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Global Research Management | Glendale | California | 91204 | United States | ||
| Foothill Eye Institute |
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| Vehicle |
| Drug |
Vehicle Ophthalmic Solution |
|
| Pasadena |
| California |
| 91107 |
| United States |
| Shettle Eye Research | Largo | Florida | 33773 | United States |
| D & H National Research Centers, INC | Miami | Florida | 33155 | United States |
| My Community Research Center, Inc. | Miami | Florida | 33155 | United States |
| Quantum Clinical Trials | Miami Beach | Florida | 33140 | United States |
| Kannarr Eye Center | Pittsburg | Kansas | 66762 | United States |
| Oculos Clinical Research | Garner | North Carolina | 27529 | United States |
| Athens Eye Care | Athens | Ohio | 45701 | United States |
| Revolution Research/ Lake Travis Eye and Laser Center | Lakeway | Texas | 78738 | United States |
| King Chulalongkorn Memorial Hospital | Bangkok | 10330 | Thailand |
| Mahidol university | Bangkok | 10400 | Thailand |
| ID | Term |
|---|---|
| D003231 | Conjunctivitis |
| ID | Term |
|---|---|
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
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