Recruiting

Phase 2

TL-925A Study of TL-925 for the Treatment of Allergic Conjunctivitis

Sponsor:

Telios Pharma, Inc.

Code:

NCT06153342

Conditions

Allergic Conjunctivitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

TL-925

Placebo

Study Details

Brief summary:

In this prospective Phase 2, single-center, randomized, double-masked, placebo-controlled study, approximately 70 subjects with allergic conjunctivitis 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.

Conditions

Allergic Conjunctivitis

Study ID

NCT06153342

Start date

Nov, 2023

Status verified date

Nov, 2023

Completion date

Jan, 2024

Anticipated

Primary completion date

Jan, 2024

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 of 0.7 LogMAR or better
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)

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: TL-925 Arm

Subjects will be dosed in clinic on days of dosing.

placebo comparator: Placebo Arm

Subjects will be dosed in clinic on days of dosing.

Interventions

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.

Primary outcome measure

Ocular itching [ Time Frame: 3, 5 and 7 minutes after CAC ]
Conjunctival redness [ Time Frame: 7, 15 and 20 minutes after CAC ]

Central Contacts and Locations

Central contacts

John Mei

(650) 542-0136 jmei@teliospharma.com

Locations

Andover Eye Associates

Recruiting

Andover, Massachusetts, United States, 01810

More Information

Sponsor

Telios Pharma, Inc.

Last update posted

Dec 1, 2023

Last verified

Nov, 2023

Keywords

TL-925
Phase II

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Telios Pharma, Inc. on 2023-12-01.