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In this prospective, Phase 2, randomized, double-masked, vehicle controlled study, approximately 60 eligible subjects will be randomized 1:1 to receive either TL-925 or placebo as topical ophthalmic eye drops administered bilaterally.
The study comprises of a screening and treatment period using the conjunctival allergen challenge model to evaluate TL-925 for the treatment of allergic conjunctivitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TL-925 Arm | Active Comparator | Subjects will be dosed in clinic. |
|
| Placebo Arm | Placebo Comparator | Subjects wil be dosed in clinic. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TL-925 | Drug | TL-925 is an eye drop. |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Itching | Ocular itching score will be reported by the subject at 3 timepoints after CAC at Visits 4d , 5d, and 6c. | 3, 5 and 7 minutes after CAC |
| Conjunctival Redness | Conjunctival redness score will be evaluated by the investigator at 3 timepoints after CAC at Visits 4d, 5d, and 6c. | 7, 15 and 20 minutes after CAC |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yulia Khalina | Contact | 908-656-2799 | ykhalina@teliospharma.com | |
| John Mei | Contact | 650-542-0136 | jmei@teliospharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advancing Vision Research | Recruiting | Smyrna | Tennessee | 37167 | United States |
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| ID | Term |
|---|---|
| D003233 | Conjunctivitis, Allergic |
| ID | Term |
|---|---|
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D006969 | Hypersensitivity, Immediate |
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| Drug |
The composition of the placebo is identical to the active formulation except for the exclusion of the active ingredient. |
|
| D006967 |
| Hypersensitivity |
| D007154 | Immune System Diseases |