Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
In this prospective, Phase 2, randomized, double-masked, vehicle controlled study, approximately 70 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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TL-925 Arm | Active Comparator | Subjects will be dosed in clinic and at home. |
|
| Placebo Arm | Placebo Comparator | Subjects will be dosed in clinic and at home. |
|
| 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 4, 5 and 6. Assessments were reported using a 0-4 numerical scale (0 = none and 4 = incapacitating itch with an irresistible urge to rub). | 3, 5 and 7 minutes after CAC |
| Conjunctival Redness | Conjunctival redness score evaluated by the investigator at 3 timepoints after CAC at Visits 4, 5 and 6. Assessments were completed using a 0-4 numerical scale (0 = none and 4 = extremely severe). | 7, 15 and 20 minutes after CAC |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Andover Eye Associates | Andover | Massachusetts | 01810 | United States |
Not provided
| ID | Term |
|---|---|
| D003233 | Conjunctivitis, Allergic |
| ID | Term |
|---|---|
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D006969 | Hypersensitivity, Immediate |
Not provided
Not provided
Not provided
Not provided
Not provided
The sponsor, investigators, and study staff will be masked throughout the study. The study site will have the capacity to unmask in case of emergency.
Following completion of the study, the randomization code will be unmasked once all data has been entered into the study database for every subject, and the database has been locked.
| 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 |