Phase 2 Dose-Response Study Evaluating the Safety and Efficacy of NCX 470 vs Latanoprost in Subjects With Open-Angle Glaucoma or Ocular Hypertension

NCT03657797 | Completed Phase 2 Results FDA Drug

• 1 other identifier: NCX-470-17001
• Study Type: interventional
• Target: 656
• Locations: 1 country
• Sites: 1

Brief 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. Three different concentrations of NCX 470 ophthalmic solution (0.021%, 0.042%, and 0.065%) will be compared to latanoprost 0.005% ophthalmic solution.

Conditions

Glaucoma, Open-Angle; Hypertension, Ocular

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Study Eye Mean Diurnal IOP at the 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.

  Baseline, Week 4

Secondary Outcomes (2)

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

  Baseline, week 1, week 2, exit visit

• Percentage of Subjects With Treatment-emergent Ocular Adverse Events

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

Study Arms (4)

NCX 470 0.021%

EXPERIMENTAL

NCX 470 Ophthalmic Solution, 0.021% dosed once daily for 4 weeks

Drug: NCX 470

NCX 470 0.042%

EXPERIMENTAL

NCX 470 Ophthalmic Solution, 0.042% dosed once daily for 4 weeks

Drug: NCX 470

NCX 470 0.065%

EXPERIMENTAL

NCX 470 Ophthalmic Solution, 0.065% dosed once daily for 4 weeks

Drug: NCX 470

Latanoprost 0.005%

ACTIVE COMPARATOR

Latanoprost Ophthalmic Solution, 0.005% dosed once daily for 4 weeks

Drug: Latanoprost 0.005%

Interventions

NCX 470 DRUG

NCX 470 Ophthalmic Solution

NCX 470 0.021%; NCX 470 0.042%; NCX 470 0.065%

Latanoprost 0.005% DRUG

Latanoprost 0.005% Ophthalmic Solution

Also known as: Latanoprost

Latanoprost 0.005%

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nicox Ophthalmics, Inc.: lead

Study Sites (1)

Texan Eye

Austin, Texas, 78731, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Interventions

Latanoprost

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Results Point of Contact

• Title: Doug Hubatsch / Chief Scientific Officer
• Organization: Nicox Ophthalmics Inc.

hubatsch@nicox.com

832-360-3022

Study Officials

• Nicox Ophthalmics, Inc.

  Nicox Ophthalmics, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2018
• First Posted: September 5, 2018
• Study Start: August 1, 2018
• Primary Completion: August 23, 2019
• Study Completion: August 23, 2019
• Last Updated: June 18, 2023
• Results First Posted: December 8, 2022

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)