RECRUITING

A Study of TL-925 for the Treatment of Allergic Conjunctivitis

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

In this prospective Phase 2, single-center, randomized, double-masked, placebo-controlled study, approximately 70 subjects with allergic conjunctivitis 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.

Official Title

A Single Center, Randomized, Double-masked, Vehicle-controlled Phase 2 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

Quick Facts

Study Start:2023-11
Study Completion:2024-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06153342

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Individuals aged 18 years or older
  2. * Female subjects of childbearing potential and their male partners must both use a highly effective contraception method during the study.
  3. * 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.
  4. * Calculated best-corrected visual activity of 0.7 LogMAR or better
  5. * Positive bilateral CAC reaction
  1. * Any systemic or ocular disease currently producing ocular redness and/or ocular discomfort, or that may interfere with the conduct of the study.
  2. * Any ocular surgical intervention within the last 3 months OR refractive surgery within the last 6 months
  3. * Any ongoing ocular infection (bacterial, viral or fungal)

Contacts and Locations

Study Contact

John Mei
CONTACT
(650) 542-0136
jmei@teliospharma.com

Study Locations (Sites)

Andover Eye Associates
Andover, Massachusetts, 01810
United States

Collaborators and Investigators

Sponsor: Telios Pharma, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11
Study Completion Date2024-01

Study Record Updates

Study Start Date2023-11
Study Completion Date2024-01

Terms related to this study

Keywords Provided by Researchers

  • TL-925
  • Phase II

Additional Relevant MeSH Terms

  • Allergic Conjunctivitis