CompletedPhase 3

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

United States691 participantsStarted 2020-06-01

Plain-language 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%.

Who can participate

Age range18 Years – 84 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Mean IOP Reduction From Time-Matched Baseline at the 8AM and 4PM Time-Points at Week 2, Week 6, and Month 3

Timeframe: Baseline, Week 2, Week 6, and Month 3

Trial details

NCT IDNCT04445519

SponsorNicox Ophthalmics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-09-16

Results submitted2024-09-19

View on ClinicalTrials.gov More Open Angle Glaucoma trials