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) (Denali)

  • End date
    Nov 11, 2024
  • participants needed
  • sponsor
    Nicox Ophthalmics, Inc.
Updated on 11 October 2022
corrected visual acuity
ophthalmic solution
intraocular pressure


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.

Condition Open Angle Glaucoma, Ocular Hypertension
Treatment Latanoprost 0.005%, NCX 470 0.1%
Clinical Study IdentifierNCT04630808
SponsorNicox Ophthalmics, Inc.
Last Modified on11 October 2022


Yes No Not Sure

Inclusion Criteria

Diagnosis of open-angle glaucoma or ocular hypertension in both eyes
Qualifying IOP at 3 time points through the day at 2 visits following washout of IOP-lowering medication, if applicable
Qualifying best-corrected visual acuity in each eye
Ability to provide informed consent and follow study instructions

Exclusion Criteria

Narrow anterior chamber angles or disqualifying corneal thickness in either eye
Clinically significant ocular disease in either eye
Previous complicated surgery or certain types of glaucoma surgery in either eye
Incisional ocular surgery or severe trauma in either eye within the past 6 months
Uncontrolled systemic disease
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