A Study Of TL-925 For The Treatment of AC

NCT06293820 | Completed Phase 2 FDA Drug

• 1 other identifier: TL-925-304
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

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 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).

  3, 5 and 7 minutes after CAC

• Conjunctival Redness

  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).

  7, 15 and 20 minutes after CAC

Study Arms (2)

TL-925 Arm

ACTIVE COMPARATOR

Subjects will be dosed in clinic and at home.

Drug: TL-925

Placebo Arm

PLACEBO COMPARATOR

Subjects will be dosed in clinic and at home.

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 of 0.7 LogMAR or better
• 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)

Andover Eye Associates

Andover, Massachusetts, 01810, United States

Location

MeSH Terms

Conditions

Conjunctivitis, Allergic

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The sponsor, investigators, and study staff will be masked throughout the study. The study site will have the capacity to unmask in case of emergency. Following completion of the study, the randomization code will be unmasked once all data has been entered into the study database for every subject, and the database has been locked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: March 5, 2024
• Study Start: April 11, 2024
• Primary Completion: May 21, 2024
• Study Completion: May 21, 2024
• Last Updated: July 3, 2024

Record last verified: 2024-07

Locations

US (1)