Phase 3 Trial of NCX 470 vs. Latanoprost in Subjects With Open-Angle Glaucoma or Ocular Hypertension

  • STATUS
    Recruiting
  • End date
    Jun 5, 2022
  • participants needed
    670
  • sponsor
    Nicox Ophthalmics, Inc.
Updated on 5 April 2021
hypertension
corrected visual acuity
glaucoma
ophthalmic solution
brimonidine tartrate ophthalmic solution
latanoprost
intraocular pressure

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%.

Details
Condition EYE DISORDER, Ocular Hypertension, Glaucoma, Pigmentary glaucoma, Eye Disorders/Infections, Dry Eye Disease, Eye Disorders/Infections (Pediatric), Eye Disease, Open Angle Glaucoma
Treatment Latanoprost 0.005%, NCX 470 0.065%, NCX 470 0.1%
Clinical Study IdentifierNCT04445519
SponsorNicox Ophthalmics, Inc.
Last Modified on5 April 2021

Eligibility

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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