Status and phase
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About
A double-masked, randomized, multi-center, placebo-controlled, parallel-group study in adult patients with Dry Eye Disease (DED). Patients will be randomly assigned to receive either SJP-0035 0.001% or placebo
Full description
There are currently no approved products available anywhere worldwide for the treatment of Dry Eye Disease (DED) that directly affect the corneal epithelium. This study will evaluate the safety and efficacy of SJP-0035 0.001%, compared with a placebo, on corneal healing. Patients meeting the requirements of the inclusion/exclusion criteria will administer 1 drop of the study drug/placebo 4 times per day for 4 weeks.
Enrollment
Sex
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Volunteers
Inclusion criteria
Exclusion criteria
Other protocol-defined inclusion/exclusion criteria could apply.
Primary purpose
Allocation
Interventional model
Masking
329 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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