MRCT Evaluating NCX 470 vs. Latanoprost in Subjects With Open-Angle Glaucoma or Ocular Hypertension (Denali)
MRCT Evaluating NCX 470 vs. Latanoprost in Subjects With Open-Angle Glaucoma or Ocular Hypertension (Denali)
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 subjecs with ocular hypertension or open-angle glaucoma. Subjects will be randomized in a 1:1 ratio to NCX 470 0.1% or to latanoprost 0.005% to be administered to both eyes once daily in the evening for up to 12 months.
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: A Phase 3, Randomized, Multi-Regional, Double-Masked, Parallel-Group Trial Evaluating the Safety and Efficacy of NCX 470 0.1% vs. Latanoprost 0.005% in Subjects With Open-Angle Glaucoma or Ocular Hypertension (Denali)
Actual Study Start Date: November 9, 2020
Estimated Primary Completion Date: November 2022
Estimated Study Completion Date: January 2023
Arm:
- Experimental: NCX 470 0.1%
- Active Comparator: Latanoprost 0.005%
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Estimated enrolment | 670 |
| Actual Study start date | 09 November 2020 |
| Estimated Study Completion Date | 01 January 2023 |