Evaluation of TL-925 for the Treatment of Allergic Conjunctivitis

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study summary

In this prospective, Phase 2, randomized, double-masked, vehicle controlled study, approximately 66 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

Primary outcome measure(s)

• Ocular Itching — 3, 5 and 7 minutes after CAC
  Ocular itching score will be reported by the subject at 3 timepoints after CAC at Visits 4b , 5, and 6b. Assessments are reported using a 0-4 numerical scale (0 = none and 4 = incapacitating itch with an irresistible urge to rub).
• Conjunctival Redness — 7, 15 and 20 minutes after CAC
  Conjunctival redness score will be evaluated by the investigator at 3 timepoints after CAC at Visits 4b, 5, and 6b. Assessments are completed using a 0-4 numerical scale (0 = none and 4 = extremely severe).

Trial sites (1)

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