A Clinical Study Evaluating Licaminlimab for Dry Eye Disease
ConditionDry Eye Disease (DED)
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorOculis
About this trial
The primary objective of this study is to evaluate the efficacy and safety of the topical ophthalmic administration of licaminlimab as compared to vehicle in participants with Dry Eye Disease and a specific genotype.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Physician diagnosis of Dry Eye Disease in the past 6 months
Use of over-the-counter tears
Must agree to genotype testing
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Artificial Tear Run-in
Other interventionArtificial tear eye drop run-in three times daily (TID) for approximately 14 days.
licaminlimab
DrugLicaminlimab eye drops three times daily (TID) for 29 days.
Vehicle of licaminlimab
Other interventionInert ophthalmic solution vehicle of licaminlimab, three times daily (TID) for 29 days.
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: licaminlimabExperimental treatment 2 interventions
Group B: VehiclePlacebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
Change from baseline in global ocular discomfort severity score at Day 29 in participants with DED and specific TNFR1 genotype
Time frame
From Day 1 to Day 29Secondary outcomes
1
Change from baseline in global ocular discomfort severity score at Day 29 in all participants with DED (independent of genotype).
Time frame
Day 1 to Day 29 Source ClinicalTrials.gov