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

Primary Purpose

Glaucoma, Open-Angle, Hypertension, Ocular

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

NCX 470

Latanoprost 0.005%

About this trial

This is an interventional treatment trial for Glaucoma, Open-Angle

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Texan Eye

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Arm Label

NCX 470 0.021%

NCX 470 0.042%

NCX 470 0.065%

Latanoprost 0.005%

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change From Baseline in Study Eye Mean Diurnal IOP at Week 1, Week 2, and 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)

Percentage of Subjects With Treatment-emergent Ocular Adverse Events

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

Full Information

NCT ID

NCT03657797

First Posted

August 31, 2018

Last Updated

June 15, 2023

Sponsor

Nicox Ophthalmics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03657797

Brief Title

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

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Completed

Study Start Date

August 1, 2018 (Actual)

Primary Completion Date

August 23, 2019 (Actual)

Study Completion Date

August 23, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Nicox Ophthalmics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glaucoma, Open-Angle, Hypertension, Ocular

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

656 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NCX 470 0.021%

Arm Type

Experimental

Arm Description

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

Arm Title

NCX 470 0.042%

Arm Type

Experimental

Arm Description

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

Arm Title

NCX 470 0.065%

Arm Type

Experimental

Arm Description

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

Arm Title

Latanoprost 0.005%

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

NCX 470

Intervention Description

NCX 470 Ophthalmic Solution

Intervention Type

Drug

Intervention Name(s)

Latanoprost 0.005%

Other Intervention Name(s)

Latanoprost

Intervention Description

Latanoprost 0.005% Ophthalmic Solution

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Baseline, Week 4

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

Baseline, week 1, week 2, exit visit

Title

Percentage of Subjects With Treatment-emergent Ocular Adverse Events

Description

Safety and tolerability based on 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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nicox Ophthalmics, Inc.

Organizational Affiliation

Nicox Ophthalmics, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Texan Eye

City

Austin

State/Province

Texas

ZIP/Postal Code

78731

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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