Recruiting
Phase 2

TL-925

Sponsor:

Telios Pharma, Inc.

Code:

NCT06686472

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, randomized, double-masked, vehicle controlled study, approximately 66 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.

Conditions

Allergic Conjunctivitis

Study ID

NCT06686472

Start date

Oct 3, 2024

Status verified date

Nov, 2024

Completion date

Dec 10, 2024

Anticipated

Primary completion date

Dec 10, 2024

Anticipated

Eligibility Criteria

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

66 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.

placebo comparator: Placebo Arm

Subjects will be dosed in clinic.

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) 542-0136jmei@teliospharma.com

Yulia Khalina

ykhalina@teliospharma.com

Locations

Telios Investigative Site

Recruiting

Memphis, Tennessee, United States, 38119

More Information

Sponsor

Telios Pharma, Inc.

Last update posted

Nov 13, 2024

Last verified

Nov, 2024

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 2024-11-13.