An Exploratory Efficacy and Safety Study of DFL24498 Topical Ophthalmic Solution Compared With Vehicle in Participants With Dry Eye Disease

Recruiting Phase 2 Interventional Study
Dry Eye Disease (DED)
Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
417 (estimated)
Sponsor
Dompé Farmaceutici S.p.A · Industry
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About This Trial
This is a Phase 2, randomized, multicenter, double masked, vehicle controlled, parallel group study to evaluate the efficacy and safety of DFL24498 topical ophthalmic solution versus vehicle in participants with dry eye disease. Approximately 417 participants aged 18 years or older who meet all eligibility criteria will be enrolled at study sites in the US. The study duration will be up to 16 week…
Trial Locations
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Eligibility Criteria
Key Inclusion Criteria: * A diagnosis of DED at least 6 months before enrollment (current use or recommended use of artificial tears for the treatment of dry eye). * The global score of the SANDE questionnaire ≥ 30 * DED in at least one eye which is characterized by the following clinical features:…
Contacts

Dompé farmaceutici S.p.A. Via Santa Lucia, 6, 20122 Milan (MI)

+39 02 583 831

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