A Study Of TL-925 For The Treatment of AC

Allergic Conjunctivitis Clinical Trial

Official title:

A Single Center, Randomized, Double-masked, Vehicle-controlled Phase 2b Study Evaluating the Safety and Efficacy of TL-925 Ophthalmic Emulsion 0.1% Compared to Vehicle for the Treatment of Allergic Conjunctivitis in the Conjunctival Allergen Challenge (Ora CAC®) Model

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06293820
• Other study ID #: TL-925-304
• Status: Recruiting
• Phase: Phase 2
• Start date: March 2024
• Est. completion date: May 2024

Study information

• Verified date: March 2024
• Source: Telios Pharma, Inc.
• Contact: John Mei
• Phone: (650) 542-0136
• Email: jmei[@]teliospharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Allergic Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Allergic

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Andover Eye Associates	Andover	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Telios Pharma, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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