A Study Of TL-925 For The Treatment of AC

Phase 2

Completed

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

• Registration Number: NCT06293820
• Lead Sponsor: Telios Pharma, Inc.

Brief Summary

In this prospective, Phase 2, randomized, double-masked, vehicle controlled study, approximately 70 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 First Submitted: 2024-02-27
• Study First Submitted QC: 2024-02-27
• Study First Posted: 2024-03-05
• Study Start: 2024-04-11
• Primary Completion: 2024-05-21
• Study Completion: 2024-05-21
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-02
• Last Update Posted: 2024-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 and at home.
Placebo Arm	Placebo	Subjects will be dosed in clinic and at home.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Andover Eye Associates; 🇺🇸 Andover, Massachusetts, United States