Open Angle Glaucoma, Ocular Hypertension
Conditions
Keywords
Glaucoma, IOP
Brief summary
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).
Detailed 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.
Interventions
DRUGAR-17043 Ophthalmic Solution
Investigational monotherapy supplied in three concentration levels: low, medium, high
DRUGPG043 Ophthalmic Solution
Investigational fixed dose combination supplied in two concentration levels: low and high
Marketed monotherapy
Marketed monotherapy
Marketed fixed dose combination
DRUGAR-17043 Vehicle
Placebo comparator
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Stage 1 Key Inclusion Criteria; * Diagnosis of OAG or OHT in both eyes. * High unmedicated IOP measurements in the study eye as specified in the protocol. * Corrected visual acuity equal to or better than +1.0 logMAR (Snellen equivalent equal to or better than 20/200) in the study eye. * Other protocol-specified inclusion criteria may apply. Stage 2 Key Inclusion Criteria: * Diagnosis of OAG or OHT in both eyes. * High unmedicated IOP measurements in the study eye as specified in the protocol. * Corrected visual acuity equal to or better than +0.7 logMAR (Snellen equivalent equal to or better than 20/100) in the study eye. * Other protocol-specified inclusion criteria may apply. Stage 1 and Stage 2 Key
Exclusion criteria
* Current use of more than 2 ocular hypotensive medications within 30 days (either eye). * Intraocular pressure greater than 36 millimeters mercury (mmHg) at Screening. * Glaucoma other than OAG. * Previous glaucoma surgery. * Any abnormality preventing reliable measurements. * Unable to demonstrate proper eyedrop instillation. * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean diurnal IOP at Day 8 (Stage 1) | Day 8 (8:00, 10:00, 12:00, 16:00) | Intraocular pressure (IOP) will be measured with a Goldmann tonometer. Diurnal IOP will be calculated as the average of the four measurements. |
| Mean diurnal IOP at Day 29 (Stage 2) | Day 29 (8:00, 10:00, 16:00) | Intraocular pressure (IOP) will be measured with a Goldmann tonometer. Diurnal IOP will be calculated as the average of the three measurements. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean percent change from diurnally adjusted baseline IOP at each post-treatment timepoint (Stage 1) | Baseline (8:00, 10:00, 12:00, 16:00), Day 1 (8:00, 10:00, 12:00), Day 8 (8:00, 10:00, 12:00, 16:00) | Intraocular pressure (IOP) will be measured with a Goldmann tonometer at each post-treatment timepoint and compared to the time-relevant (corresponding) baseline measurement. Baseline is defined as the last visit prior to initiation of treatment. |
| Mean change from baseline mean diurnal IOP at each post-treatment timepoint (Stage 1) | Baseline (8:00, 10:00, 12:00, 16:00), Day 1 (8:00, 10:00, 12:00), Day 8 (8:00, 10:00, 12:00, 16:00) | Intraocular pressure (IOP) will be measured with a Goldmann tonometer. The baseline mean diurnal IOP will be calculated as the average of the four baseline measurements. Baseline is defined as the last visit prior to initiation of treatment. |
| Mean percent change from baseline mean diurnal IOP at each post-treatment timepoint (Stage 1) | Baseline (8:00, 10:00, 12:00, 16:00); Day 1 (8:00, 10:00, 12:00), Day 8 (8:00, 10:00, 12:00, 16:00) | Intraocular pressure (IOP) will be measured with a Goldmann tonometer. The baseline mean diurnal IOP will be calculated as the average of the four baseline measurements. Baseline is defined as the last visit prior to initiation of treatment. |
| Mean IOP at each post-treatment timepoint (Stage 2) | Day 8 (8:00, 10:00, 16:00); Day 15 (8:00, 10:00, 16:00); Day 29 (8:00, 10:00, 16:00) | Intraocular pressure (IOP) will be measured with a Goldmann tonometer at each post-treatment timepoint. |
| Mean IOP at each post-treatment timepoint (Stage 1) | Day 1 (8:00, 10:00, 12:00), Day 8 (8:00, 10:00, 12:00, 16:00) | Intraocular pressure (IOP) will be measured with a Goldmann tonometer at each post-treatment timepoint. |
| Mean percent change from diurnally adjusted baseline IOP at each post-treatment timepoint (Stage 2) | Baseline (8:00, 10:00, 16:00); Day 8 (8:00, 10:00, 16:00); Day 15 (8:00, 10:00, 16:00); Day 29 (8:00, 10:00, 16:00) | Intraocular pressure (IOP) will be measured with a Goldmann tonometer at each post-treatment timepoint and compared to the time-relevant (corresponding) baseline measurement. Baseline is defined as the last visit prior to initiation of treatment. |
| Mean change from baseline mean diurnal IOP at each post-treatment timepoint (Stage 2) | Baseline (8:00, 10:00, 16:00); Day 8 (8:00, 10:00, 16:00); Day 15 (8:00, 10:00, 16:00); Day 29 (8:00, 10:00, 16:00) | Intraocular pressure (IOP) will be measured with a Goldmann tonometer. The baseline mean diurnal IOP will be calculated as the average of the three baseline measurements. Baseline is defined as the last visit prior to initiation of treatment. |
| Mean percent change from baseline mean diurnal IOP at each post-treatment timepoint (Stage 2) | Baseline (8:00, 10:00, 16:00); Day 8 (8:00, 10:00, 16:00); Day 15 (8:00, 10:00, 16:00); Day 29 (8:00, 10:00, 16:00) | Intraocular pressure (IOP) will be measured with a Goldmann tonometer. The baseline mean diurnal IOP will be calculated as the average of the three baseline measurements. Baseline is defined as the last visit prior to initiation of treatment. |
| Mean change from the diurnally adjusted baseline IOP at each post-treatment timepoint (Stage 2) | Baseline (8:00, 10:00, 16:00); Day 8 (8:00, 10:00, 16:00); Day 15 (8:00, 10:00, 16:00); Day 29 (8:00, 10:00, 16:00) | Intraocular pressure (IOP) will be measured with a Goldmann tonometer at each post-treatment timepoint and compared to the time-relevant (corresponding) baseline measurement. Baseline is defined as the last visit prior to initiation of treatment. |
| Mean change from the diurnally adjusted baseline IOP at each post-treatment timepoint (Stage 1) | Baseline (8:00, 10:00, 12:00, 16:00), Day 1 (8:00, 10:00, 12:00), Day 8 (8:00, 10:00, 12:00, 16:00) | Intraocular pressure (IOP) will be measured with a Goldmann tonometer at each post-treatment timepoint and compared to the time-relevant (corresponding) baseline measurement. Baseline is defined as the last visit prior to initiation of treatment. |
Countries
United States
Outcome results
None listed