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

NCT07220408 | Recruiting Phase 2 FDA Drug

• 1 other identifier: TL-925-314
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Conjunctivitis

Outcome Measures

Primary Outcomes (2)

• Ocular Itching

  Ocular itching score will be reported by the subject at 3 timepoints after CAC at Visits 4d , 5d, and 6c.

  3, 5 and 7 minutes after CAC

• Conjunctival Redness

  Conjunctival redness score will be evaluated by the investigator at 3 timepoints after CAC at Visits 4d, 5d, and 6c.

  7, 15 and 20 minutes after CAC

Study Arms (2)

TL-925 Arm

ACTIVE COMPARATOR

Subjects will be dosed in clinic.

Drug: TL-925

Placebo Arm

PLACEBO COMPARATOR

Subjects wil be dosed in clinic.

Drug: Placebo

Interventions

TL-925 DRUG

TL-925 is an eye drop.

TL-925 Arm

Placebo DRUG

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

Placebo Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Telios Pharma, Inc.: lead

Study Sites (1)

Advancing Vision Research

Smyrna, Tennessee, 37167, United States

RECRUITING

MeSH Terms

Conditions

Conjunctivitis, Allergic

Condition Hierarchy (Ancestors)

Conjunctivitis; Conjunctival Diseases; Eye Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Yulia Khalina

CONTACT

908-656-2799; ykhalina@teliospharma.com

John Mei

CONTACT

650-542-0136; jmei@teliospharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2025
• First Posted: October 23, 2025
• Study Start: October 23, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: November 25, 2025

Record last verified: 2025-11

Locations

US (1)