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Completed

NCT Number: NCT03657797

Phase 2 Dose-Response Study Evaluating the Safety and Efficacy 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. Three different concentrations of NCX 470 ophthalmic solution (0.021%, 0.042%, and 0.065%) will be compared to latanoprost 0.005% ophthalmic solution.

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Key information

Conditions

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

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Texan Eye

Austin, Texas, 78731, 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 throughout the day at 2 visits following washout of IOP-lowering medication, if applicable
  • Qualifying best-corrected visual acuity (BCVA) using the Early Treatment of Diabetic Retinopathy Study (ETDRS) protocol in each eye
  • Ability to provide informed consent and follow study instructions

Exclusion criteria

  • Pigmentary or pseudoexfoliative glaucoma
  • 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

Drug

NCX 470 Ophthalmic Solution

Latanoprost 0.005%

Drug

Latanoprost 0.005% Ophthalmic Solution

Other names: Latanoprost

Primary outcomes

  1. Change From Baseline in Study Eye Mean Diurnal IOP at the Week 4

    Time frame: Baseline, Week 4

    Participants used medication in both eyes for 4 weeks with one eye was designated the study eye at baseline. The study eye was defined as the eye with the highest mean diurnal intraocular pressure (IOP) value at baseline (or the right eye if both eyes had the same IOP value at baseline). Mean diurnal IOP at week 4 is the average of the 8AM, 10AM and 4PM IOPs at week 4.

Secondary outcomes

  1. Change From Baseline in Study Eye Mean Diurnal IOP at Week 1, Week 2, and Exit Visit

    Time frame: Baseline, week 1, week 2, exit visit

    Participants used medication in both eyes from baseline to the evening prior to the week 4 visit. One eye was designated the study eye at baseline. The study eye was defined as the eye with the highest mean diurnal intraocular pressure (IOP) value at baseline (or the right eye if both eyes had the same IOP value at baseline). Mean diurnal IOP is the average of the 8AM, 10AM and 4PM values. Visits were conducted at week 1, week 2, week 4, and an exit visit (1 to 2 days following the week 4 visit)

  2. Percentage of Subjects With Treatment-emergent Ocular Adverse Events

    Time frame: 4 weeks for adverse events and through 30 days post-treatment for serious adverse events

    Safety and tolerability based on percentage of subjects with treatment-emergent ocular adverse events

Sponsors and collaborators

Lead sponsor

Nicox Ophthalmics, Inc.

Industry

Registry information

Official study title

A Phase 2, Randomized, Multicenter, Masked, Parrallel-Group, Dose-Response Study Evaluating the Safety and Efficacy of NCX 470 (3 Doses: 0.021%, 0.042%, and 0.065%) vs. Latanoprost 0.005% in Subjects With Open-Angle Glaucoma or Ocular Hypertension

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 5, 2018
Registry last updated
Jun 18, 2023

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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