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The objectives of this trial are to assess the safety, tolerability and efficacy of A197 ophthalmic solution in comparison to a vehicle control in the treatment of subjects with Dry Eye Disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A197 Ophthalmic Solution, High Dose | Experimental |
| |
| A197 Ophthalmic Solution, Low Dose | Experimental |
| |
| A197 Vehicle Control | Placebo Comparator |
| |
| Active Comparator | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A197 Ophthalmic Solution | Drug | A197 Ophthalmic Solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in total corneal fluorescein staining (CFS) | Corneal Fluorescein Staining (tCFS) is graded based on a modified National Eye Institute (NEI) scale. The NEI scale divides the cornea in 5 regions: central, inferior, superior, nasal, temporal. The score for each region ranges from 0-4 using 0.5 unit increments; 0 corresponds to no staining, 4 corresponds to maximum staining. The total score is the sum of the 5 regions ranging from 0-20. | 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in eye dryness via the Visual Analogue Scale (VAS) | Eye dryness is rated on a visual analogue scale (VAS) ranging from 0-100; 0 corresponds to no symptoms and 100 to severe symptoms. | 12 Weeks |
| Change from baseline in lissamine green conjunctival staining (LGCS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David S Tierney, MD | Aramis Biosciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aramis Site 113 | Birmingham | Alabama | 35233 | United States | ||
| Aramis Site 121 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36729473 | Derived | Mangwani-Mordani S, Goodman CF, Galor A. Novel Treatments for Chronic Ocular Surface Pain. Cornea. 2023 Mar 1;42(3):261-271. doi: 10.1097/ICO.0000000000003193. Epub 2022 Dec 19. |
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| A197 Vehicle Control | Drug | A197 Vehicle Control |
|
| Active Comparator | Drug | Active Comparator |
|
Lissamine green conjunctival staining (LGCS) is graded based on the NEI Scale. The NEI scale divides the conjunctiva in 6 regions with the score for each region ranging from 0-3; 0 corresponds to no staining, 3 corresponds to maximum staining. The total score is the sum of the 6 regions ranging from 0-18. |
| 12 Weeks |
| Change from baseline in bulbar conjunctival hyperemia (CCLRU) | Bulbar conjunctival hyperemia is graded based on the Cornea and Contact Lens Research Unit (CCLRU) grading scale where 0 corresponds to none, 4 corresponds to severe. | 12 Weeks |
| Garden Grove |
| California |
| 92843 |
| United States |
| Aramis Site 120 | Glendale | California | 95817 | United States |
| Aramis Site 106 | Long Beach | California | 90805 | United States |
| Aramis Site 124 | Los Angeles | California | 90013 | United States |
| Aramis Site 107 | Murrieta | California | 92562 | United States |
| Aramis Site 102 | Newport Beach | California | 92663 | United States |
| Aramis Site 116 | Petaluma | California | 94954 | United States |
| Aramis Site 109 | Rancho Cordova | California | 95670 | United States |
| Aramis Site 101 | Delray Beach | Florida | 33484 | United States |
| Aramis Site 112 | Jacksonville | Florida | 32204 | United States |
| Aramis Site 117 | Largo | Florida | 33773 | United States |
| Aramis Site 118 | Edgewood | Kentucky | 41017 | United States |
| Aramis Site 114 | Kansas City | Missouri | 64111 | United States |
| Aramis Site 111 | St Louis | Missouri | 63128 | United States |
| Aramis Site 108 | Las Vegas | Nevada | 89119 | United States |
| Aramis Site 110 | Garner | North Carolina | 27529 | United States |
| Aramis Site 122 | Shelby | North Carolina | 28150 | United States |
| Aramis Site 119 | Mason | Ohio | 45040 | United States |
| Aramis Site 123 | Cranberry Township | Pennsylvania | 16066 | United States |
| Aramis Site 115 | Goodlettsville | Tennessee | 37072 | United States |
| Aramis Site 103 | Memphis | Tennessee | 38119 | United States |
| Aramis Site 104 | Lakeway | Texas | 78738 | United States |
| Aramis Site 105 | San Antonio | Texas | 78215 | United States |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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