Trial Outcomes & Findings for Phase 3 Trial of NCX 470 vs. Latanoprost in Subjects With Open-Angle Glaucoma or Ocular Hypertension (NCT NCT04445519)
NCT ID: NCT04445519
Last Updated: 2025-06-24
Results Overview
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.
COMPLETED
PHASE3
691 participants
Baseline, Week 2, Week 6, and Month 3
2025-06-24
Participant Flow
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.
Participants were consented and screened for eligibility. Subjects underwent a medication wash-out. Eligible subjects meeting IOP criteria were randomized to 1 of 3 groups. All participants dosed once daily in both eyes. After 30 subjects in all 3 arms completed 2 weeks on drug, a planned, Adaptive Analysis was performed. Based upon the results of this analysis, enrollment continued in the NCX 470 0.1% and latanoprost 0.005% groups and the NCX 0.065% arm was discontinued.
Participant milestones
| Measure |
NCX 470 0.065%
NCX 470 Ophthalmic Solution, 0.065% dosed once daily to both eyes
|
NCX 470 0.1%
NCX 470 Ophthalmic Solution, 0.1% dosed once daily to both eyes
|
Latanoprost 0.005%
Latanoprost Ophthalmic Solution, 0.005% dosed once daily to both eyes
|
|---|---|---|---|
|
Overall Study
STARTED
|
30
|
328
|
333
|
|
Overall Study
COMPLETED
|
27
|
314
|
316
|
|
Overall Study
NOT COMPLETED
|
3
|
14
|
17
|
Reasons for withdrawal
| Measure |
NCX 470 0.065%
NCX 470 Ophthalmic Solution, 0.065% dosed once daily to both eyes
|
NCX 470 0.1%
NCX 470 Ophthalmic Solution, 0.1% dosed once daily to both eyes
|
Latanoprost 0.005%
Latanoprost Ophthalmic Solution, 0.005% dosed once daily to both eyes
|
|---|---|---|---|
|
Overall Study
Due to adaptive design
|
3
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
4
|
|
Overall Study
Sponsor or IRB Decision
|
0
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
3
|
|
Overall Study
Adverse Event
|
0
|
8
|
6
|
|
Overall Study
Other Reason
|
0
|
1
|
1
|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
Baseline Characteristics
Phase 3 Trial of NCX 470 vs. Latanoprost in Subjects With Open-Angle Glaucoma or Ocular Hypertension
Baseline characteristics by cohort
| Measure |
NCX 470 0.065%
n=30 Participants
NCX 470 Ophthalmic Solution, 0.065% dosed once daily to both eyes
|
NCX 470 0.1%
n=328 Participants
NCX 470 Ophthalmic Solution, 0.1% dosed once daily to both eyes
|
Latanoprost 0.005%
n=333 Participants
Latanoprost Ophthalmic Solution, 0.005% dosed once daily to both eyes
|
Total
n=691 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
168 Participants
n=7 Participants
|
174 Participants
n=5 Participants
|
353 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
19 Participants
n=5 Participants
|
160 Participants
n=7 Participants
|
159 Participants
n=5 Participants
|
338 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
200 Participants
n=7 Participants
|
188 Participants
n=5 Participants
|
405 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
128 Participants
n=7 Participants
|
145 Participants
n=5 Participants
|
286 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
133 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=5 Participants
|
267 Participants
n=7 Participants
|
265 Participants
n=5 Participants
|
555 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
110 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
228 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
212 Participants
n=7 Participants
|
216 Participants
n=5 Participants
|
448 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
328 participants
n=7 Participants
|
332 participants
n=5 Participants
|
690 participants
n=4 Participants
|
|
Region of Enrollment
China
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Time-Matched IOP
Time-Matched IOP 8AM
|
28.07 mmHg
STANDARD_DEVIATION 2.286 • n=5 Participants
|
28.28 mmHg
STANDARD_DEVIATION 2.000 • n=7 Participants
|
28.22 mmHg
STANDARD_DEVIATION 2.011 • n=5 Participants
|
28.19 mmHg
STANDARD_DEVIATION 2.099 • n=4 Participants
|
|
Time-Matched IOP
Time-Matched IOP 4PM
|
25.15 mmHg
STANDARD_DEVIATION 2.589 • n=5 Participants
|
25.52 mmHg
STANDARD_DEVIATION 2.455 • n=7 Participants
|
25.40 mmHg
STANDARD_DEVIATION 2.422 • n=5 Participants
|
25.36 mmHg
STANDARD_DEVIATION 2.489 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 2, Week 6, and Month 3Population: 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).
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.
Outcome measures
| Measure |
NCX 470 0.1%
n=328 eyes
NCX 470 Ophthalmic Solution, 0.1% dosed once daily to both eyes
|
Latanoprost 0.005%
n=333 eyes
Latanoprost Ophthalmic Solution, 0.005% dosed once daily to both eyes
|
Latanoprost 0.005%
Latanoprost Ophthalmic Solution, 0.005% dosed once daily to both eyes
|
|---|---|---|---|
|
Mean IOP Reduction From Time-Matched Baseline at the 8AM and 4PM Time-Points at Week 2, Week 6, and Month 3
Mean change from baseline - Week 2 8AM
|
-9.43 mmHg
Standard Deviation 3.443
|
-8.85 mmHg
Standard Deviation 3.349
|
—
|
|
Mean IOP Reduction From Time-Matched Baseline at the 8AM and 4PM Time-Points at Week 2, Week 6, and Month 3
Mean change from baseline - Week 2 4PM
|
-8.01 mmHg
Standard Deviation 3.379
|
-7.11 mmHg
Standard Deviation 3.330
|
—
|
|
Mean IOP Reduction From Time-Matched Baseline at the 8AM and 4PM Time-Points at Week 2, Week 6, and Month 3
Mean change from baseline - Week 6 8AM
|
-9.69 mmHg
Standard Deviation 3.129
|
-9.33 mmHg
Standard Deviation 3.395
|
—
|
|
Mean IOP Reduction From Time-Matched Baseline at the 8AM and 4PM Time-Points at Week 2, Week 6, and Month 3
Mean change from baseline - Week 6 4PM
|
-8.18 mmHg
Standard Deviation 3.093
|
-7.14 mmHg
Standard Deviation 3.283
|
—
|
|
Mean IOP Reduction From Time-Matched Baseline at the 8AM and 4PM Time-Points at Week 2, Week 6, and Month 3
Mean change from baseline - Month 3 8AM
|
-9.61 mmHg
Standard Deviation 3.196
|
-9.39 mmHg
Standard Deviation 3.345
|
—
|
|
Mean IOP Reduction From Time-Matched Baseline at the 8AM and 4PM Time-Points at Week 2, Week 6, and Month 3
Mean change from baseline - Month 3 4PM
|
-8.00 mmHg
Standard Deviation 3.026
|
-7.31 mmHg
Standard Deviation 3.296
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 6, and Month 3Population: 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).
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).
Outcome measures
| Measure |
NCX 470 0.1%
n=328 eyes
NCX 470 Ophthalmic Solution, 0.1% dosed once daily to both eyes
|
Latanoprost 0.005%
n=333 eyes
Latanoprost Ophthalmic Solution, 0.005% dosed once daily to both eyes
|
Latanoprost 0.005%
Latanoprost Ophthalmic Solution, 0.005% dosed once daily to both eyes
|
|---|---|---|---|
|
Reduction From Baseline in Mean Diurnal IOP at Week 2, Week 6, and Month 3 in the Study Eye
Change from Baseline to Week 2 in Mean Diurnal IOP
|
-8.82 mmHg
Standard Deviation 3.057
|
-8.05 mmHg
Standard Deviation 3.020
|
—
|
|
Reduction From Baseline in Mean Diurnal IOP at Week 2, Week 6, and Month 3 in the Study Eye
Change from Baseline to Week 6 in Mean Diurnal IOP
|
-9.01 mmHg
Standard Deviation 2.758
|
-8.34 mmHg
Standard Deviation 3.030
|
—
|
|
Reduction From Baseline in Mean Diurnal IOP at Week 2, Week 6, and Month 3 in the Study Eye
Change from Baseline to Month 3 in Mean Diurnal IOP
|
-8.90 mmHg
Standard Deviation 2.697
|
-8.41 mmHg
Standard Deviation 2.952
|
—
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Safety population - all subjects who were randomized to treatment and received 1 dose of study medication.
Safety and tolerability based on number subjects with treatment emergent ocular adverse events.
Outcome measures
| Measure |
NCX 470 0.1%
n=30 Participants
NCX 470 Ophthalmic Solution, 0.1% dosed once daily to both eyes
|
Latanoprost 0.005%
n=328 Participants
Latanoprost Ophthalmic Solution, 0.005% dosed once daily to both eyes
|
Latanoprost 0.005%
n=333 Participants
Latanoprost Ophthalmic Solution, 0.005% dosed once daily to both eyes
|
|---|---|---|---|
|
Number of Subjects With Treatment Emergent Adverse Events (TEAE) by Treatment Group in the Safety Population
Any Ocular TEAEs
|
13 numbers subjects with TEAEs
|
113 numbers subjects with TEAEs
|
58 numbers subjects with TEAEs
|
|
Number of Subjects With Treatment Emergent Adverse Events (TEAE) by Treatment Group in the Safety Population
Any Non-Ocular TEAEs
|
1 numbers subjects with TEAEs
|
37 numbers subjects with TEAEs
|
32 numbers subjects with TEAEs
|
|
Number of Subjects With Treatment Emergent Adverse Events (TEAE) by Treatment Group in the Safety Population
Any serious Ocular TEAEs
|
0 numbers subjects with TEAEs
|
0 numbers subjects with TEAEs
|
0 numbers subjects with TEAEs
|
|
Number of Subjects With Treatment Emergent Adverse Events (TEAE) by Treatment Group in the Safety Population
Any serious Non-Ocular TEAEs
|
0 numbers subjects with TEAEs
|
4 numbers subjects with TEAEs
|
3 numbers subjects with TEAEs
|
|
Number of Subjects With Treatment Emergent Adverse Events (TEAE) by Treatment Group in the Safety Population
Any serious Ocular TEAEs related to study drug
|
0 numbers subjects with TEAEs
|
0 numbers subjects with TEAEs
|
0 numbers subjects with TEAEs
|
|
Number of Subjects With Treatment Emergent Adverse Events (TEAE) by Treatment Group in the Safety Population
Any serious Non-Ocular TEAEs related to study drug
|
0 numbers subjects with TEAEs
|
0 numbers subjects with TEAEs
|
0 numbers subjects with TEAEs
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Subjects who were randomized to study drug and did not complete the study.
Number of subjects discontinued from the study.
Outcome measures
| Measure |
NCX 470 0.1%
n=30 Participants
NCX 470 Ophthalmic Solution, 0.1% dosed once daily to both eyes
|
Latanoprost 0.005%
n=328 Participants
Latanoprost Ophthalmic Solution, 0.005% dosed once daily to both eyes
|
Latanoprost 0.005%
n=333 Participants
Latanoprost Ophthalmic Solution, 0.005% dosed once daily to both eyes
|
|---|---|---|---|
|
Rate of Discontinuation
|
3 Participants
|
14 Participants
|
17 Participants
|
Adverse Events
NCX 470 0.065%
NCX 470 0.1%
Latanoprost 0.005%
Serious adverse events
| Measure |
NCX 470 0.065%
n=30 participants at risk
NCX 470 Ophthalmic Solution, 0.065% dosed once daily to both eyes
|
NCX 470 0.1%
n=328 participants at risk
NCX 470 Ophthalmic Solution, 0.1% dosed once daily to both eyes
|
Latanoprost 0.005%
n=333 participants at risk
Latanoprost Ophthalmic Solution, 0.005% dosed once daily to both eyes
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/30 • Adverse events were collected through 90 days of dosing of study drug.
|
0.30%
1/328 • Number of events 1 • Adverse events were collected through 90 days of dosing of study drug.
|
0.00%
0/333 • Adverse events were collected through 90 days of dosing of study drug.
|
|
Infections and infestations
Sepsis
|
0.00%
0/30 • Adverse events were collected through 90 days of dosing of study drug.
|
0.30%
1/328 • Number of events 1 • Adverse events were collected through 90 days of dosing of study drug.
|
0.00%
0/333 • Adverse events were collected through 90 days of dosing of study drug.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/30 • Adverse events were collected through 90 days of dosing of study drug.
|
0.30%
1/328 • Number of events 1 • Adverse events were collected through 90 days of dosing of study drug.
|
0.00%
0/333 • Adverse events were collected through 90 days of dosing of study drug.
|
|
Infections and infestations
Corona Virus Infection
|
0.00%
0/30 • Adverse events were collected through 90 days of dosing of study drug.
|
0.00%
0/328 • Adverse events were collected through 90 days of dosing of study drug.
|
0.60%
2/333 • Number of events 2 • Adverse events were collected through 90 days of dosing of study drug.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/30 • Adverse events were collected through 90 days of dosing of study drug.
|
0.30%
1/328 • Number of events 1 • Adverse events were collected through 90 days of dosing of study drug.
|
0.00%
0/333 • Adverse events were collected through 90 days of dosing of study drug.
|
|
Nervous system disorders
Transient ischemic attack
|
0.00%
0/30 • Adverse events were collected through 90 days of dosing of study drug.
|
0.00%
0/328 • Adverse events were collected through 90 days of dosing of study drug.
|
0.30%
1/333 • Number of events 1 • Adverse events were collected through 90 days of dosing of study drug.
|
Other adverse events
| Measure |
NCX 470 0.065%
n=30 participants at risk
NCX 470 Ophthalmic Solution, 0.065% dosed once daily to both eyes
|
NCX 470 0.1%
n=328 participants at risk
NCX 470 Ophthalmic Solution, 0.1% dosed once daily to both eyes
|
Latanoprost 0.005%
n=333 participants at risk
Latanoprost Ophthalmic Solution, 0.005% dosed once daily to both eyes
|
|---|---|---|---|
|
Eye disorders
Conjunctival hyperemia
|
16.7%
5/30 • Number of events 5 • Adverse events were collected through 90 days of dosing of study drug.
|
11.0%
36/328 • Number of events 36 • Adverse events were collected through 90 days of dosing of study drug.
|
2.1%
7/333 • Number of events 7 • Adverse events were collected through 90 days of dosing of study drug.
|
|
Eye disorders
Ocular hyperemia
|
3.3%
1/30 • Number of events 1 • Adverse events were collected through 90 days of dosing of study drug.
|
11.9%
39/328 • Number of events 39 • Adverse events were collected through 90 days of dosing of study drug.
|
3.3%
11/333 • Number of events 11 • Adverse events were collected through 90 days of dosing of study drug.
|
|
Eye disorders
Eye pruritus
|
3.3%
1/30 • Number of events 1 • Adverse events were collected through 90 days of dosing of study drug.
|
5.2%
17/328 • Number of events 17 • Adverse events were collected through 90 days of dosing of study drug.
|
1.8%
6/333 • Number of events 6 • Adverse events were collected through 90 days of dosing of study drug.
|
|
General disorders
Instillation site pain
|
16.7%
5/30 • Number of events 5 • Adverse events were collected through 90 days of dosing of study drug.
|
6.1%
20/328 • Number of events 20 • Adverse events were collected through 90 days of dosing of study drug.
|
2.4%
8/333 • Number of events 8 • Adverse events were collected through 90 days of dosing of study drug.
|
Additional Information
Doug Hubatsch/Chief Scientific Officer
Nicox Ophthalmics, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place