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CompletedNCT03657797Updated Jun 18, 2023Results posted

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 interventional study of NCX 470 and Latanoprost 0.005% in Glaucoma, Open-Angle and Hypertension, Ocular, sponsored by Nicox Ophthalmics, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-06-18.

Sponsored by Nicox Ophthalmics, Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
656
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Glaucoma, Open-Angle
  • Hypertension, Ocular
03

In context

Glaucoma, Open-Angle

924 studies on the registry are indexed under Glaucoma, Open-Angle; 117 are open to participants now.

This study's enrollment of 656 is above the median of 80 across 692 interventional studies indexed under Glaucoma, Open-Angle.

Browse Glaucoma, Open-Angle studies →

Lead sponsor

Nicox Ophthalmics, Inc. is the lead sponsor of 7 studies on the registry; none are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 4 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 and follow study instructions

Exclusion criteria

Exclusion Criteria:

  • Pigmentary or pseudoexfoliative glaucoma
  • Narrow anterior chamber angles or disqualifying corneal thickness in either eye
  • 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
656 participants (actual)

Study arms

  • Experimental
    NCX 470 0.021%

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

    Drug: NCX 470

  • Experimental
    NCX 470 0.042%

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

    Drug: NCX 470

  • Experimental
    NCX 470 0.065%

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

    Drug: NCX 470

  • Active comparator
    Latanoprost 0.005%

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

    Drug: Latanoprost 0.005%

Interventions

06

What researchers measure

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.

    Time frame: Baseline, Week 4

Secondary outcomes

  1. 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)

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

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

    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

07

Results

Posted Dec 8, 2022

Participant flow

Participants were recruited from ophthalmologists' clinics in the US. The first participant for the study was screened in August 2018 and the last participant exited the trial in August 2019.

Participant flow — Overall Study
MilestoneNCX 470 0.021%NCX 470 0.042%NCX 470 0.065%Latanoprost 0.005%
Started111108107107
Completed111105102107
Not completed0350
Withdrew: Lost to follow-up0110
Withdrew: Physician decision0100
Withdrew: Withdrawal by subject0120
Withdrew: Adverse event0020

Outcome measures

PrimaryChange 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.

Time frame:
Baseline, Week 4
Reported as:
Mean · mmHg
Change From Baseline in Study Eye Mean Diurnal IOP at the Week 4
mmHgNCX 470 0.021%NCX 470 0.042%NCX 470 0.065%Latanoprost 0.005%
Change From Baseline in Study Eye Mean Diurnal IOP at the Week 4-7.79 ± 2.606-8.28 ± 2.511-8.70 ± 3.150-7.41 ± 2.666
Statistical analysis
  • NCX 470 0.021% vs Latanoprost 0.005% · ANCOVA · p = 0.2666 (p-value was not adjusted for multiple comparisons) · Mean difference (final values): -0.40 · 95% CI -1.11 to 0.31
  • NCX 470 0.042% vs Latanoprost 0.005% · ANCOVA · p = 0.0281 (p-value was not adjusted for multiple comparisons) · Mean difference (final values): -0.81 · 95% CI -1.52 to -0.09
  • NCX 470 0.065% vs Latanoprost 0.005% · ANCOVA · p = 0.0009 (p-value was not adjusted for multiple comparisons) · Mean difference (final values): -1.23 · 95% CI -1.96 to -0.51
SecondaryChange 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)

Time frame:
Baseline, week 1, week 2, exit visit
Reported as:
Mean · mmHg
Change From Baseline in Study Eye Mean Diurnal IOP at Week 1, Week 2, and Exit Visit
mmHgNCX 470 0.021%NCX 470 0.042%NCX 470 0.065%Latanoprost 0.005%
Week 1-7.73 ± 2.783-8.15 ± 2.577-8.66 ± 3.098-7.54 ± 2.735
Week 2-7.96 ± 2.774-8.38 ± 2.439-8.87 ± 2.797-7.99 ± 2.504
Exit Visit-4.95 ± 3.237-5.59 ± 2.827-5.98 ± 3.019-4.89 ± 3.009
Statistical analysis
  • NCX 470 0.021% vs Latanoprost 0.005% · ANCOVA · p = <0.9788 (p-value was not adjusted for multiple comparisons)Upper 95% CIs were 0.51 (week 1), 0.68 (week 2), 0.75 (exit visit); p-values were 0.5560 (week 1), 0.9788 (week 2), 0.8796 (exit visit)
  • NCX 470 0.042% vs Latanoprost 0.005% · ANCOVA · p = <0.3863 (p-value was not adjusted for multiple comparisons)Upper 95% CIs were 0.20 (week 1), 0.38 (week 2), 0.11 (exit visit); p-values were 0.1556 (week 1), 0.3863 (week 2), 0.0912 (exit visit)
  • NCX 470 0.065% vs Latanoprost 0.005% · ANCOVA · p = <0.0174 (p-value was not adjusted for multiple comparisons)Upper 95% CIs were -0.35 (week 1), -0.15 (week 2), -0.27 (exit visit); p-values were 0.0040 (week 1), 0.0174 (week 2), 0.0093 (exit visit)
SecondaryPercentage of Subjects With Treatment-emergent Ocular Adverse Events

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
Reported as:
Count of participants · Participants
Percentage of Subjects With Treatment-emergent Ocular Adverse Events
ParticipantsNCX 470 0.021%NCX 470 0.042%NCX 470 0.065%Latanoprost 0.005%
Percentage of Subjects With Treatment-emergent Ocular Adverse Events34525021

Adverse events

Collected over 29 days with collection of serious adverse events for up to 30 days post study exit. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
NCX 470 0.021%0/111 (0%)1/111 (0.9%)24/111 (21.6%)
NCX 470 0.042%0/108 (0%)2/108 (1.9%)42/108 (38.9%)
NCX 470 0.065%0/107 (0%)1/107 (0.9%)39/107 (36.4%)
Latanoprost 0.005%0/107 (0%)0/107 (0%)20/107 (18.7%)
Most frequent serious events
Most frequent serious events
EventNCX 470 0.021%NCX 470 0.042%NCX 470 0.065%Latanoprost 0.005%
B-cell lymphomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/1110/1081/1070/107
EndophthalmitisEye disorders0/1111/1080/1070/107
HypertensionVascular disorders0/1111/1080/1070/107
Transient ischaemic attackNervous system disorders1/1110/1080/1070/107
Most frequent other events
Most frequent other events
EventNCX 470 0.021%NCX 470 0.042%NCX 470 0.065%Latanoprost 0.005%
Conjunctival hyperaemiaEye disorders12/11124/10818/1077/107
Instillation site painGeneral disorders8/11110/10812/1076/107
Ocular hyperaemiaEye disorders5/1119/10810/1075/107
Eye pruritusEye disorders2/1111/1086/1070/107
Instillation site pruritusGeneral disorders2/1115/1083/1073/107

Baseline characteristics

Participants contribute a study eye (fellow eye also treated)

Age, Categorical
Age, Categorical(Participants)NCX 470 0.021%NCX 470 0.042%NCX 470 0.065%Latanoprost 0.005%Total
<=18 years00000
Between 18 and 65 years48465355202
>=65 years63625452231
Sex: Female, Male
Sex: Female, Male(Participants)NCX 470 0.021%NCX 470 0.042%NCX 470 0.065%Latanoprost 0.005%Total
Female54715857240
Male57374950193
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)NCX 470 0.021%NCX 470 0.042%NCX 470 0.065%Latanoprost 0.005%Total
Hispanic or Latino2320161877
Not Hispanic or Latino88889189356
Unknown or Not Reported00000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)NCX 470 0.021%NCX 470 0.042%NCX 470 0.065%Latanoprost 0.005%Total
American Indian or Alaska Native00101
Asian21317
Native Hawaiian or Other Pacific Islander00000
Black or African American35323235134
White72747170287
More than one race21014
Unknown or Not Reported00000
Region of Enrollment
Region of Enrollment(Participants)NCX 470 0.021%NCX 470 0.042%NCX 470 0.065%Latanoprost 0.005%Total
United States111108107107433
Study Eye Baseline Mean Diurnal IOP (mmHg)
Study Eye Baseline Mean Diurnal IOP (mmHg)(mmHg)NCX 470 0.021%NCX 470 0.042%NCX 470 0.065%Latanoprost 0.005%Total
Mean26.62 ± 1.66326.89 ± 1.98726.80 ± 2.06926.68 ± 1.74526.75 ± 1.866
08

Study locations

1 site
  • Texan Eye
    Austin, Texas 78731, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2018 to primary completion in Aug 2019, 12 months.

Results were first posted in Dec 2022, 3 years 3 months after primary completion. A results delay was requested in Sep 2020.

Of 38 industry-sponsored phase 2 interventional studies under Glaucoma, Open-Angle, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 16. This study's 12 months is close to that.

Counting every sponsor, half of 41 studies reached it within 11 months; a quarter within 7 and three quarters within 18.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 31, 2018
First posted
Sep 5, 2018
StartActual
Aug 1, 2018
Primary completionActual
Aug 23, 2019
CompletionActual
Aug 23, 2019
Results delay requested
Sep 18, 2020
Results first posted
Dec 8, 2022
Last update
Jun 18, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03657797
Lead sponsor
Nicox Ophthalmics, Inc.
Responsible party
Sponsor
First posted
Sep 5, 2018
Start date
Aug 1, 2018
Primary completion
Aug 23, 2019
Completion
Aug 23, 2019
Results posted
Dec 8, 2022
Last update
Jun 18, 2023

Study contacts

Nicox Ophthalmics, Inc.
study director · Nicox Ophthalmics, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: NCX 470

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Nicox Ophthalmics, Inc.

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