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Evaluation of TL-925 for the Treatment of Seasonal Allergic Conjunctivitis

A Single Center, Randomized, Double-masked, Vehicle Controlled Phase 2 Study Evaluating the Safety and Efficacy of TL-925 Ophthalmic Emulsion 0.1% Compared to Vehicle for the Treatment of Seasonal Allergic Conjunctivitis in the Conjunctival Allergen Challenge (Ora-CAC®) Model

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07220408
Enrollment
60
Registered
2025-10-23
Start date
2025-10-23
Completion date
2026-02-28
Last updated
2025-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Conjunctivitis

Brief summary

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.

Interventions

DRUGTL-925

TL-925 is an eye drop.

DRUGPlacebo

The composition of the placebo is identical to the active formulation except for the exclusion of the active ingredient.

Sponsors

Telios Pharma, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Individuals aged 18 years or older * 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 * Positive bilateral CAC reaction

Exclusion criteria

* Any systemic or ocular disease currently producing ocular redness and/or ocular discomfort, or that may interfere with the conduct of the study. * 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)

Design outcomes

Primary

MeasureTime frameDescription
Ocular Itching3, 5 and 7 minutes after CACOcular itching score will be reported by the subject at 3 timepoints after CAC at Visits 4d , 5d, and 6c.
Conjunctival Redness7, 15 and 20 minutes after CACConjunctival redness score will be evaluated by the investigator at 3 timepoints after CAC at Visits 4d, 5d, and 6c.

Countries

United States

Contacts

Primary ContactYulia Khalina
ykhalina@teliospharma.com908-656-2799
Backup ContactJohn Mei
jmei@teliospharma.com650-542-0136

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026