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

ConditionAllergic Conjunctivitis

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorTelios Pharma, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

TL-925
Drug
TL-925 is an eye drop.
Placebo
Drug
The composition of the placebo is identical to the active formulation except for the exclusion of the active ingredient.

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: TL-925 ArmActive comparator 1 intervention

Group B: Placebo ArmPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Ocular Itching

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

Time frame

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.

Time frame

7, 15 and 20 minutes after CAC

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Telios Pharma, Inc.

Lead sponsor

Source ClinicalTrials.gov

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