Glaucoma, Open-AnglePhase 2NCT03657797

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

A Phase 2 study testing NCX 470 and Latanoprost 0.005% in people with Glaucoma, Open-Angle and Hypertension, Ocular, run by Nicox Ophthalmics, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Glaucoma, Open-Angle, Hypertension, Ocular
What is being tested?: NCX 470 and Latanoprost 0.005%
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 656 participants
Where: 1 siteUnited States
Study dates: 1 Aug 2018to 23 Aug 2019
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Texan Eye
Austin, Texas, 78731

Other trials in United States

About this study

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

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
Being tested: NCX 470, Latanoprost 0.005%
Medical subject headings: Glaucoma, Open-Angle, Ocular Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NCX 470Drug
NCX 470 Ophthalmic Solution
Latanoprost 0.005%Drug
Also called Latanoprost
Latanoprost 0.005% Ophthalmic Solution

Study groups in NCT03657797
Study group	Role	What they receive
NCX 470 0.021%	Experimental	NCX 470 Ophthalmic Solution, 0.021% dosed once daily for 4 weeks Receives: Drug: NCX 470
NCX 470 0.042%	Experimental	NCX 470 Ophthalmic Solution, 0.042% dosed once daily for 4 weeks Receives: Drug: NCX 470
NCX 470 0.065%	Experimental	NCX 470 Ophthalmic Solution, 0.065% dosed once daily for 4 weeks Receives: Drug: NCX 470
Latanoprost 0.005%	Active comparator	Latanoprost Ophthalmic Solution, 0.005% dosed once daily for 4 weeks Receives: Drug: Latanoprost 0.005%

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline, Week 4

Secondary outcomes (2)

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)
Measured: Baseline, week 1, week 2, exit visit
Percentage of Subjects With Treatment-emergent Ocular Adverse Events
Safety and tolerability based on percentage of subjects with treatment-emergent ocular adverse events
Measured: 4 weeks for adverse events and through 30 days post-treatment for serious adverse events

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 201823 Aug 2019

First posted5 Sep 2018
Study start1 Aug 2018
Primary completion23 Aug 2019
Study completion23 Aug 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Glaucoma, Open-AngleStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 656 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03657797
Sponsor's protocol ID: NCX-470-17001
Status last verified: Jun 2023
First submitted: 31 Aug 2018
Last updated: 18 Jun 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03657797
Acronym / sponsor ID: NCX-470-17001
Conditions: Glaucoma, Open-Angle, Hypertension, Ocular
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 656 participants (actual)
Lead sponsor: Nicox Ophthalmics, Inc.Industry (pharma, biotech, devices)
Study start: 1 Aug 2018 (actual)
Primary completion: 23 Aug 2019 (actual)
Study completion: 23 Aug 2019 (actual)
First posted: 5 Sep 2018 (actual)
Results: Posted 8 Dec 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
NCX 470 0.021%	Experimental	Drug: NCX 470NCX 470 Ophthalmic Solution, 0.021% dosed once daily for 4 weeks
NCX 470 0.042%	Experimental	Drug: NCX 470NCX 470 Ophthalmic Solution, 0.042% dosed once daily for 4 weeks
NCX 470 0.065%	Experimental	Drug: NCX 470NCX 470 Ophthalmic Solution, 0.065% dosed once daily for 4 weeks
Latanoprost 0.005%	Active comparator	Drug: Latanoprost 0.005%Latanoprost Ophthalmic Solution, 0.005% dosed once daily for 4 weeks

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NCX 470NCX 470 Ophthalmic Solution	Drug	NCX 470 0.021%, NCX 470 0.042%, NCX 470 0.065%
Latanoprost 0.005%Also: LatanoprostLatanoprost 0.005% Ophthalmic Solution	Drug	Latanoprost 0.005%

Primary outcome

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.

2 secondary outcomes

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
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

Results and safety

Results posted to the registry on 8 Dec 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
NCX 470 0.021%	111	111
NCX 470 0.042%	108	105
NCX 470 0.065%	107	102
Latanoprost 0.005%	107	107

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

Time frame: Baseline, Week 4. Mean (Standard Deviation). Unit: mmHg

Measure	NCX 470 0.021% n = 110	NCX 470 0.042% n = 105	NCX 470 0.065% n = 102	Latanoprost 0.005% n = 107
Value	-7.79 (2.606)	-8.28 (2.511)	-8.70 (3.150)	-7.41 (2.666)

NCX 470 0.021% vs Latanoprost 0.005%: Mean Difference (Final Values): -0.40 (95% CI -1.11 to 0.31), p = 0.2666, ANCOVA
NCX 470 0.042% vs Latanoprost 0.005%: Mean Difference (Final Values): -0.81 (95% CI -1.52 to -0.09), p = 0.0281, ANCOVA
NCX 470 0.065% vs Latanoprost 0.005%: Mean Difference (Final Values): -1.23 (95% CI -1.96 to -0.51), p = 0.0009, ANCOVA

Population analysed: All participants who were randomized and who had diurnal IOP values at week 4

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 29 days with collection of serious adverse events for up to 30 days post study exit. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
NCX 470 0.021%	1 of 111 (0.9%)	24 of 111 (21.6%)	0 of 111
NCX 470 0.042%	2 of 108 (1.9%)	42 of 108 (38.9%)	0 of 108
NCX 470 0.065%	1 of 107 (0.9%)	39 of 107 (36.4%)	0 of 107
Latanoprost 0.005%	0 of 107 (0%)	20 of 107 (18.7%)	0 of 107

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Nicox Ophthalmics, Inc. study director

Nicox Ophthalmics, Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing NCX 470 and Latanoprost 0.005% in people with Glaucoma, Open-Angle and Hypertension, Ocular, run by Nicox Ophthalmics, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Study Eye Mean Diurnal IOP at the Week 4 (time frame: Baseline, Week 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03657797.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.