University Eye Specialists | Clinical Research Department
Status and phase
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About
The purpose of this two-stage clinical trial is to assess the safety and hypotensive efficacy of AR-17043 and PG043 ophthalmic solutions in subjects with open-angle glaucoma (OAG) or ocular hypertension (OHT).
Full description
During Stage 1, approximately 100 adult subjects with OAG or OHT will be randomized to 5 arms: 3 different concentrations of AR-17043, placebo comparator, or netarsudil 0.02% (Rhopressa®) for a treatment duration of 7 days.
During Stage 2, approximately 350 adult subjects with OAG or OHT will be randomized to 5 arms: low and high concentrations of PG043 (AR-17043/latanoprost 0.005%), AR-17043 high concentration, latanoprost, or netarsudil 0.02%/latanoprost 0.005% (Rocklatan®) for a treatment duration of 28 days.
Enrollment
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Inclusion and exclusion criteria
Stage 1 Key Inclusion Criteria;
Stage 2 Key Inclusion Criteria:
Stage 1 and Stage 2 Key Exclusion Criteria:
Primary purpose
Allocation
Interventional model
Masking
450 participants in 10 patient groups, including a placebo group
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Central trial contact
Alcon Call Center
Data sourced from clinicaltrials.gov
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