Evaluation of TL-925 for the Treatment of Allergic Conjunctivitis

Phase 2

Recruiting

• Conditions: Allergic Conjunctivitis
• Interventions: Drug: TL-925; Drug: Placebo

• Registration Number: NCT06686472
• Lead Sponsor: Telios Pharma, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-10-03
• Status Verified: 2024-11
• Study First Submitted: 2024-11-11
• Study First Submitted QC: 2024-11-11
• Last Update Submitted: 2024-11-11
• Study First Posted: 2024-11-13
• Last Update Posted: 2024-11-13
• Primary Completion: 2024-12-10
• Study Completion: 2024-12-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 66

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TL-925 Arm	TL-925	Subjects will be dosed in clinic.
Placebo Arm	Placebo	Subjects will be dosed in clinic.

Primary Outcome Measures

Name	Time	Method
Ocular Itching	3, 5 and 7 minutes after CAC	Ocular itching score will be reported by the subject at 3 timepoints after CAC at Visits 4b , 5, and 6b. Assessments are reported using a 0-4 numerical scale (0 = none and 4 = incapacitating itch with an irresistible urge to rub).
Conjunctival Redness	7, 15 and 20 minutes after CAC	Conjunctival redness score will be evaluated by the investigator at 3 timepoints after CAC at Visits 4b, 5, and 6b. Assessments are completed using a 0-4 numerical scale (0 = none and 4 = extremely severe).

Trial Locations

Locations (1)

Telios Investigative Site; 🇺🇸 Memphis, Tennessee, United States