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Completed

NCT Number: NCT04445519

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

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%.

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Key information

Conditions

Open Angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

18 year–84 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Eye Research Foundation

Newport Beach, California, 92663, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NCX 470 0.065% (initial phase of trial)

Drug

NCX 470 Ophthalmic Solution, 0.065% (initial phase of trial)

Latanoprost 0.005% (initial phase of trial)

Drug

Latanoprost Ophthalmic Solution, 0.005%

Other names: Latanoprost

NCX 470 0.1% (initial phase of trial)

Drug

NCX 470 Ophthalmic Solution, 0.1%

NCX 470 0.1% (remainder of trial)

Drug

NCX 470 Ophthalmic Solution, 0.1%

Latanoprost 0.005% (remainder of trial)

Drug

Latanoprost Ophthalmic Solution, 0.005%

Primary outcomes

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

    Time frame: Baseline, Week 2, Week 6, and Month 3

    The analysis performed as part of the Adaptive Dose Phase of the study was to evaluate the efficacy and safety of both concentrations of NCX 470 compared to Latanoprost. The primary endpoint for the interim analysis was mean diurnal IOP. Subsequent to the interim analysis at Week 2, the NCX 470 0.065% arm was discontinued and the primary analysis only included NCX 470 0.1% vs Latanoprost. The primary efficacy outcome results are reported for the NCX 470 0.1% and Latanoprost 0.005% treatment groups at Week 2, Week 6, and Month 3. As prespecified in the Statistical Analysis Plan, mean change from baseline in time-matched IOP was not calculated for the 0.065% group.

    The study eye was defined as the eye with the highest mean diurnal intraocular pressure (IOP) value at baseline (or right eye if both eyes had the same IOP value at baseline). The fellow eye was followed for safety.

Secondary outcomes

  1. Reduction From Baseline in Mean Diurnal IOP at Week 2, Week 6, and Month 3 in the Study Eye

    Time frame: Baseline, Week 2, Week 6, and Month 3

    Subjects in the NCX 470 0.065% treatment group were discontinued at Week 2 based upon the results of the planned, interim analysis.

    Subjects in the NCX 470 0.1% and Latanoprost 0.005% treatment groups continued for 3 months.

    Participants used medication in both eyes for 3 months with 1 eye designated as study eye at baseline. The study eye was defined as the eye with the highest mean diurnal intraocular pressure (IOP) value at baseline (or right eye if both eyes had the same IOP value at baseline).

  2. Number of Subjects With Treatment Emergent Adverse Events (TEAE) by Treatment Group in the Safety Population

    Time frame: 3 months

    Safety and tolerability based on number subjects with treatment emergent ocular adverse events.

  3. Rate of Discontinuation

    Time frame: 3 months

    Number of subjects discontinued from the study.

Sponsors and collaborators

Lead sponsor

Nicox Ophthalmics, Inc.

Industry

Registry information

Official study 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)

Acronym: Mont Blanc

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 24, 2020
Registry last updated
Jun 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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