NCT05283395

Rocklatan® Evaluation

A Multicenter, Open-Label Rocklatan® (Netarsudil/Latanoprost Ophthalmic Solution) 0.02%/0.005% Evaluation of IOP Lowering Efficacy and Safety as Replacement of Current Medical Therapy Regimen for the Reduction of Elevated Intraocular Pressure in Patients With Glaucoma or Ocular Hypertension

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 136 (actual)
• Sponsor: Aerie Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the IOP-lowering effect when subjects are switched from various latanoprost-based regimens to Rocklatan. Subjects will stop their IOP-lowering medical therapy regimen and dose with Rocklatan for the duration of the study (12 weeks).

Detailed description

Enrollment will be stratified according to subject's IOP-lowering medical therapy regimen as follows: * Latanoprost monotherapy (Latanoprost Mono) * Latanoprost plus 1 additional IOP-lowering agent (Latanoprost +1) * Latanoprost plus 2 additional IOP-lowering agents (Latanoprost +2) Aerie Pharmaceuticals was acquired by Alcon Research LLC on November 22, 2022.

Conditions

• Glaucoma

Interventions

Type	Name	Description
DRUG	Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution	Commercially available ophthalmic solution indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension

Timeline

• Start date: 2022-03-28
• Primary completion: 2023-03-22
• Completion: 2023-03-22
• First posted: 2022-03-17
• Last updated: 2024-04-03
• Results posted: 2024-04-03

Locations

21 sites across 1 country: United States

Regulatory

• FDA-regulated drug study