Phase 3 Trial of NCX 470 vs. Latanoprost in Subjects With Open-Angle Glaucoma or Ocular Hypertension (Mont Blanc)
Phase 3 Trial of NCX 470 vs. Latanoprost in Subjects With Open-Angle Glaucoma or Ocular Hypertension (Mont Blanc)
Brief Summary:
The objective of this clinical study is to evaluate the safety and efficacy of NCX 470 Ophthalmic Solution in lowering intraocular pressure (IOP) in patients with ocular hypertension or open-angle glaucoma. In the adaptive dose selection phase of the trial, subjects will be randomized in a 1:1:1 ratio to one of two doses of NCX 470 (0.065% or 0.1%) or to latanoprost 0.005%. Following the selection of one dose of NCX 470, subjects will be randomized in a 1:1 ratio to the chosen dose of NCX 470 or to latanoprost 0.005%.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 670 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: double-masked
Primary Purpose: Treatment
Official Title: Phase 3, Randomized, Adaptive Dose-Selection, Multi-regional, Double-Masked, Parallel-Group, 3-Month Trial Evaluating the Safety and Efficacy of NCX 470 vs. Latanoprost 0.005% in Subjects With Open-Angle Glaucoma or Ocular Hypertension (Mont Blanc)
Actual Study Start Date: June 1, 2020
Estimated Primary Completion Date: June 2022
Estimated Study Completion Date: June 2022
Arm:
- Experimental: NCX 470 0.065%
- Experimental: NCX 470 0.1%
- Active Comparator: Latanoprost 0.005%
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Estimated enrolment | 670 |
| Actual Study start date | 01 June 2020 |
| Estimated Study Completion Date | 01 June 2022 |