Next Generation Rocklatan

Alcon

Status and phase: Not yet enrolling; Phase 2

Conditions: Open Angle Glaucoma; Ocular Hypertension

Treatments: Drug: AR-17043 Ophthalmic Solution; Drug: Netarsudil 0.02%/Latanoprost 0.005% Ophthalmic Solution; Drug: PG043 Ophthalmic Solution; Drug: Latanoprost 0.005% Ophthalmic Solution; Drug: Netarsudil 0.02% Ophthalmic Solution; Drug: AR-17043 Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT06441643

GLR305-E001

Details and patient eligibility

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: 450 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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450 participants in 10 patient groups, including a placebo group

AR-17043 low concentration (Stage 1)

Experimental group

Description:

AR-17043 Ophthalmic Solution, one drop in each eye in the morning on Day 1, followed by one drop in each eye in the evening on Days 2-7.

Treatment:

Drug: AR-17043 Ophthalmic Solution

AR-17043 medium concentration (Stage 1)

Experimental group

Description:

AR-17043 Ophthalmic Solution, one drop in each eye in the morning on Day 1, followed by one drop in each eye in the evening on Days 2-7.

Treatment:

Drug: AR-17043 Ophthalmic Solution

AR-17043 high concentration (Stage 1)

Experimental group

Description:

AR-17043 Ophthalmic Solution, one drop in each eye in the morning on Day 1, followed by one drop in each eye in the evening on Days 2-7.

Treatment:

Drug: AR-17043 Ophthalmic Solution

AR-17043 vehicle (Stage 1)

Placebo Comparator group

Description:

AR-17043 Vehicle, one drop in each eye in the morning on Day 1, followed by one drop in each eye in the evening on Days 2-7.

Treatment:

Drug: AR-17043 Vehicle

Rhopressa (Stage 1)

Active Comparator group

Description:

Netarsudil 0.02% Ophthalmic Solution, one drop in each eye in the morning on Day 1, followed by one drop in each eye in the evening on Days 2-7.

Treatment:

Drug: Netarsudil 0.02% Ophthalmic Solution

PG043 low concentration (Stage 2)

Experimental group

Description:

PG043 Ophthalmic Solution, one drop in each eye in the evening on Days 1-28.

Treatment:

Drug: PG043 Ophthalmic Solution

PG043 high concentration (Stage 2)

Experimental group

Description:

PG043 Ophthalmic Solution, one drop in each eye in the evening on Days 1-28.

Treatment:

Drug: PG043 Ophthalmic Solution

AR-17043 high concentration (Stage 2)

Active Comparator group

Description:

AR-17043 Ophthalmic Solution, one drop in each eye in the evening on Days 1-28.

Treatment:

Drug: AR-17043 Ophthalmic Solution

Latanoprost (Stage 2)

Active Comparator group

Description:

Latanoprost 0.005% Ophthalmic Solution, one drop in each eye in the evening on Days 1-28.

Treatment:

Drug: Latanoprost 0.005% Ophthalmic Solution

Rocklatan (Stage 2)

Active Comparator group

Description:

Netarsudil 0.02%/Latanoprost 0.005% Ophthalmic Solution, one drop in each eye in the evening on Days 1-28.

Treatment:

Drug: Netarsudil 0.02%/Latanoprost 0.005% Ophthalmic Solution