A Study of TL-925 for the Treatment of Allergic Conjunctivitis
NCT ID: NCT06153342
Last Updated: 2023-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
70 participants
INTERVENTIONAL
2023-11-30
2024-01-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
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.
Study Groups
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TL-925 Arm
Subjects will be dosed in clinic on days of dosing.
TL-925
TL-925 is an eye drop.
Placebo Arm
Subjects will be dosed in clinic on days of dosing.
Placebo
The composition of the placebo is identical to the active formulation except for the exclusion of the active ingredient.
Interventions
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TL-925
TL-925 is an eye drop.
Placebo
The composition of the placebo is identical to the active formulation except for the exclusion of the active ingredient.
Eligibility Criteria
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Inclusion Criteria
* Female subjects of childbearing potential and their male partners must both use a highly effective contraception method during the study.
* Documented history of ocular allergies and a positive skin test reaction to a seasonal (grass, ragweed, tree pollen) or perennial (cat dander, dog dander, dust mites, cockroach) allergen as confirmed by an allergic skin test conducted at Visit 1 or within the past 60 months.
* Calculated best-corrected visual activity of 0.7 LogMAR or better
* Positive bilateral CAC reaction
Exclusion Criteria
* Any ocular surgical intervention within the last 3 months OR refractive surgery within the last 6 months
* Any ongoing ocular infection (bacterial, viral or fungal)
18 Years
ALL
No
Sponsors
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Telios Pharma, Inc.
INDUSTRY
Responsible Party
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Locations
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Andover Eye Associates
Andover, Massachusetts, United States
Countries
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Central Contacts
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Other Identifiers
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TL-925-302
Identifier Type: -
Identifier Source: org_study_id