A Phase 3 interventional study of NCX 470 0.065% (initial phase of trial) and Latanoprost 0.005% (initial phase of trial) in Open Angle Glaucoma and Ocular Hypertension, sponsored by Nicox Ophthalmics, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 84 Years. Per ClinicalTrials.gov, last updated 2025-06-24.
Sponsored by Nicox Ophthalmics, Inc. · Phase 3, Interventional, and Treatment
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. In the adaptive dose selection phase of the trial, subjects will be randomized in a 1:1:1 ratio to one of two doses of NCX 470 (0.065% or 0.1%) or to latanoprost 0.005%. Following the selection of one dose of NCX 470, subjects will be randomized in a 1:1 ratio to the chosen dose of NCX 470 or to latanoprost 0.005%.
924 studies on the registry are indexed under Glaucoma, Open-Angle; 117 are open to participants now.
This study's enrollment of 691 is above the median of 80 across 692 interventional studies indexed under Glaucoma, Open-Angle.
Browse Glaucoma, Open-Angle studies →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.
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Exclusion Criteria:
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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.
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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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NCX 470 Ophthalmic Solution, 0.065% dosed once daily to both eyes (initial phase of trial)
Drug: NCX 470 0.065% (initial phase of trial)
NCX 470 Ophthalmic Solution, 0.1% dosed once daily to both eyes (initial phase of trial)
Drug: NCX 470 0.1% (initial phase of trial)
Latanoprost Ophthalmic Solution, 0.005% dosed once daily to both eyes (initial phase of trial)
Drug: Latanoprost 0.005% (initial phase of trial)
NCX 470 Ophthalmic Solution, 0.1% dosed once daily to both eyes (chosen dose of NCX 470 to continue in remainder of trial)
Drug: NCX 470 0.1% (remainder of trial)
Latanoprost Ophthalmic Solution, 0.005% dosed once daily to both eyes (active comparator for remainder of trial)
Drug: Latanoprost 0.005% (remainder of trial)
NCX 470 Ophthalmic Solution, 0.065% (initial phase of trial)
Latanoprost Ophthalmic Solution, 0.005%
Also known as: Latanoprost
NCX 470 Ophthalmic Solution, 0.1%
NCX 470 Ophthalmic Solution, 0.1%
Latanoprost Ophthalmic Solution, 0.005%
Mean IOP Reduction From Time-Matched Baseline at the 8AM and 4PM Time-Points at Week 2, Week 6, and Month 3
The analysis performed as part of the Adaptive Dose Phase of the study was to evaluate the efficacy and safety of both concentrations of NCX 470 compared to Latanoprost. The primary endpoint for the interim analysis was mean diurnal IOP. Subsequent to the interim analysis at Week 2, the NCX 470 0.065% arm was discontinued and the primary analysis only included NCX 470 0.1% vs Latanoprost. The primary efficacy outcome results are reported for the NCX 470 0.1% and Latanoprost 0.005% treatment groups at Week 2, Week 6, and Month 3. As prespecified in the Statistical Analysis Plan, mean change from baseline in time-matched IOP was not calculated for the 0.065% group. The study eye was defined as the eye with the highest mean diurnal intraocular pressure (IOP) value at baseline (or right eye if both eyes had the same IOP value at baseline). The fellow eye was followed for safety.
Time frame: Baseline, Week 2, Week 6, and Month 3
Reduction From Baseline in Mean Diurnal IOP at Week 2, Week 6, and Month 3 in the Study Eye
Subjects in the NCX 470 0.065% treatment group were discontinued at Week 2 based upon the results of the planned, interim analysis. Subjects in the NCX 470 0.1% and Latanoprost 0.005% treatment groups continued for 3 months. Participants used medication in both eyes for 3 months with 1 eye designated as study eye at baseline. The study eye was defined as the eye with the highest mean diurnal intraocular pressure (IOP) value at baseline (or right eye if both eyes had the same IOP value at baseline).
Time frame: Baseline, Week 2, Week 6, and Month 3
Number of Subjects With Treatment Emergent Adverse Events (TEAE) by Treatment Group in the Safety Population
Safety and tolerability based on number subjects with treatment emergent ocular adverse events.
Time frame: 3 months
Rate of Discontinuation
Number of subjects discontinued from the study.
Time frame: 3 months
Participants were recruited from 56 ophthalmologists' clinics in the US and 1 clinic in China. The first participant for the study was screened in June 2020 and the last participant exited the trial in September 2022.
| Milestone | NCX 470 0.065% | NCX 470 0.1% | Latanoprost 0.005% |
|---|---|---|---|
| Started | 30 | 328 | 333 |
| Completed | 27 | 314 | 316 |
| Not completed | 3 | 14 | 17 |
| Withdrew: Due to adaptive design | 3 | 0 | 0 |
| Withdrew: Lost to follow-up | 0 | 1 | 4 |
| Withdrew: Sponsor or irb decision | 0 | 1 | 2 |
| Withdrew: Withdrawal by subject | 0 | 3 | 3 |
| Withdrew: Adverse event | 0 | 8 | 6 |
| Withdrew: Other reason | 0 | 1 | 1 |
| Withdrew: Protocol violation | 0 | 0 | 1 |
The analysis performed as part of the Adaptive Dose Phase of the study was to evaluate the efficacy and safety of both concentrations of NCX 470 compared to Latanoprost. The primary endpoint for the interim analysis was mean diurnal IOP. Subsequent to the interim analysis at Week 2, the NCX 470 0.065% arm was discontinued and the primary analysis only included NCX 470 0.1% vs Latanoprost. The primary efficacy outcome results are reported for the NCX 470 0.1% and Latanoprost 0.005% treatment groups at Week 2, Week 6, and Month 3. As prespecified in the Statistical Analysis Plan, mean change from baseline in time-matched IOP was not calculated for the 0.065% group. The study eye was defined as the eye with the highest mean diurnal intraocular pressure (IOP) value at baseline (or right eye if both eyes had the same IOP value at baseline). The fellow eye was followed for safety.
| mmHg | NCX 470 0.1% | Latanoprost 0.005% |
|---|---|---|
| Mean change from baseline - Week 2 8AM | -9.43 ± 3.443 | -8.85 ± 3.349 |
| Mean change from baseline - Week 2 4PM | -8.01 ± 3.379 | -7.11 ± 3.330 |
| Mean change from baseline - Week 6 8AM | -9.69 ± 3.129 | -9.33 ± 3.395 |
| Mean change from baseline - Week 6 4PM | -8.18 ± 3.093 | -7.14 ± 3.283 |
| Mean change from baseline - Month 3 8AM | -9.61 ± 3.196 | -9.39 ± 3.345 |
| Mean change from baseline - Month 3 4PM | -8.00 ± 3.026 | -7.31 ± 3.296 |
Subjects in the NCX 470 0.065% treatment group were discontinued at Week 2 based upon the results of the planned, interim analysis. Subjects in the NCX 470 0.1% and Latanoprost 0.005% treatment groups continued for 3 months. Participants used medication in both eyes for 3 months with 1 eye designated as study eye at baseline. The study eye was defined as the eye with the highest mean diurnal intraocular pressure (IOP) value at baseline (or right eye if both eyes had the same IOP value at baseline).
| mmHg | NCX 470 0.1% | Latanoprost 0.005% |
|---|---|---|
| Change from Baseline to Week 2 in Mean Diurnal IOP | -8.82 ± 3.057 | -8.05 ± 3.020 |
| Change from Baseline to Week 6 in Mean Diurnal IOP | -9.01 ± 2.758 | -8.34 ± 3.030 |
| Change from Baseline to Month 3 in Mean Diurnal IOP | -8.90 ± 2.697 | -8.41 ± 2.952 |
Safety and tolerability based on number subjects with treatment emergent ocular adverse events.
| numbers subjects with TEAEs | NCX 470 0.065% | NCX 470 0.1% | Latanoprost 0.005% |
|---|---|---|---|
| Any Ocular TEAEs | 13 | 113 | 58 |
| Any Non-Ocular TEAEs | 1 | 37 | 32 |
| Any serious Ocular TEAEs | 0 | 0 | 0 |
| Any serious Non-Ocular TEAEs | 0 | 4 | 3 |
| Any serious Ocular TEAEs related to study drug | 0 | 0 | 0 |
| Any serious Non-Ocular TEAEs related to study drug | 0 | 0 | 0 |
Number of subjects discontinued from the study.
| Participants | NCX 470 0.065% | NCX 470 0.1% | Latanoprost 0.005% |
|---|---|---|---|
| Rate of Discontinuation | 3 | 14 | 17 |
Collected over Adverse events were collected through 90 days of dosing of study drug.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| NCX 470 0.065% | 0/30 (0%) | 0/30 (0%) | 12/30 (40%) |
| NCX 470 0.1% | 0/328 (0%) | 4/328 (1.2%) | 112/328 (34.1%) |
| Latanoprost 0.005% | 2/333 (0.6%) | 3/333 (0.9%) | 32/333 (9.6%) |
| Event | NCX 470 0.065% | NCX 470 0.1% | Latanoprost 0.005% |
|---|---|---|---|
| Corona Virus InfectionInfections and infestations | 0/30 | 0/328 | 2/333 |
| Lung neoplasm malignantNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/30 | 1/328 | 0/333 |
| SepsisInfections and infestations | 0/30 | 1/328 | 0/333 |
| CellulitisInfections and infestations | 0/30 | 1/328 | 0/333 |
| Angina pectorisCardiac disorders | 0/30 | 1/328 | 0/333 |
| Transient ischemic attackNervous system disorders | 0/30 | 0/328 | 1/333 |
| Event | NCX 470 0.065% | NCX 470 0.1% | Latanoprost 0.005% |
|---|---|---|---|
| Conjunctival hyperemiaEye disorders | 5/30 | 36/328 | 7/333 |
| Instillation site painGeneral disorders | 5/30 | 20/328 | 8/333 |
| Ocular hyperemiaEye disorders | 1/30 | 39/328 | 11/333 |
| Eye pruritusEye disorders | 1/30 | 17/328 | 6/333 |
A study eye was assigned based upon the baseline IOP collected at the Eligibility Visits. The primary efficacy analysis was performed on the study eye and the fellow was followed for safety.
| Age, Categorical(Participants) | NCX 470 0.065% | NCX 470 0.1% | Latanoprost 0.005% | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 11 | 168 | 174 | 353 |
| >=65 years | 19 | 160 | 159 | 338 |
| Sex: Female, Male(Participants) | NCX 470 0.065% | NCX 470 0.1% | Latanoprost 0.005% | Total |
|---|---|---|---|---|
| Female | 17 | 200 | 188 | 405 |
| Male | 13 | 128 | 145 | 286 |
| Ethnicity (NIH/OMB)(Participants) | NCX 470 0.065% | NCX 470 0.1% | Latanoprost 0.005% | Total |
|---|---|---|---|---|
| Hispanic or Latino | 7 | 59 | 67 | 133 |
| Not Hispanic or Latino | 23 | 267 | 265 | 555 |
| Unknown or Not Reported | 0 | 2 | 1 | 3 |
| Race (NIH/OMB)(Participants) | NCX 470 0.065% | NCX 470 0.1% | Latanoprost 0.005% | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 2 | 3 |
| Asian | 0 | 5 | 3 | 8 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 | 2 |
| Black or African American | 9 | 110 | 109 | 228 |
| White | 20 | 212 | 216 | 448 |
| More than one race | 0 | 0 | 2 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | NCX 470 0.065% | NCX 470 0.1% | Latanoprost 0.005% | Total |
|---|---|---|---|---|
| United States | 30 | 328 | 332 | 690 |
| China | 0 | 0 | 1 | 1 |
| Time-Matched IOP(mmHg) | NCX 470 0.065% | NCX 470 0.1% | Latanoprost 0.005% | Total |
|---|---|---|---|---|
| Time-Matched IOP 8AM | 28.07 ± 2.286 | 28.28 ± 2.000 | 28.22 ± 2.011 | 28.19 ± 2.099 |
| Time-Matched IOP 4PM | 25.15 ± 2.589 | 25.52 ± 2.455 | 25.40 ± 2.422 | 25.36 ± 2.489 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jun 2020 to primary completion in Sep 2022, 27 months.
Results were first posted in May 2025, 2 years 8 months after primary completion. A results delay was requested in Sep 2022.
Of 47 industry-sponsored phase 3 interventional studies under Glaucoma, Open-Angle, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 39. This study's 27 months is close to that.
Counting every sponsor, half of 49 studies reached it within 25 months; a quarter within 12 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: NCX 470 · Latanoprost
Nicox Ophthalmics, Inc.