Trial Outcomes & Findings for Phase 2 Dose-Response Study Evaluating the Safety and Efficacy of NCX 470 vs Latanoprost in Subjects With Open-Angle Glaucoma or Ocular Hypertension (NCT NCT03657797)

Last Updated: 2023-06-18

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

656 participants

Primary outcome timeframe

Baseline, Week 4

Results posted on

2023-06-18

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.

Potential participants were screened for eligibility and those on intraocular pressure (IOP) lowering medication were required to undergo a wash out of 5 to 42 days (dependent on the class of medication). After the appropriate washout period, or after a minimum of 5 days for participants who were not on IOP lowering medication at screening, participants underwent 2 eligibility visits held 3 to 7 days apart. Those who qualified were randomized to one of the 4 treatment groups.

Unit of analysis: study eyes

Participant milestones

Participant milestones
Measure	NCX 470 0.021% NCX 470 Ophthalmic Solution, 0.021% dosed once daily for 4 weeks NCX 470: NCX 470 Ophthalmic Solution	NCX 470 0.042% NCX 470 Ophthalmic Solution, 0.042% dosed once daily for 4 weeks NCX 470: NCX 470 Ophthalmic Solution	NCX 470 0.065% NCX 470 Ophthalmic Solution, 0.065% dosed once daily for 4 weeks NCX 470: NCX 470 Ophthalmic Solution	Latanoprost 0.005% Latanoprost Ophthalmic Solution, 0.005% dosed once daily for 4 weeks Latanoprost 0.005%: Latanoprost 0.005% Ophthalmic Solution
Overall Study STARTED	111 111	108 108	107 107	107 107
Overall Study COMPLETED	111 111	105 105	102 102	107 107
Overall Study NOT COMPLETED	0 0	3 3	5 5	0 0

Reasons for withdrawal

Reasons for withdrawal
Measure	NCX 470 0.042% NCX 470 Ophthalmic Solution, 0.042% dosed once daily for 4 weeks NCX 470: NCX 470 Ophthalmic Solution	NCX 470 0.065% NCX 470 Ophthalmic Solution, 0.065% dosed once daily for 4 weeks NCX 470: NCX 470 Ophthalmic Solution
Overall Study Lost to Follow-up	1	1
Overall Study Physician Decision	1	0
Overall Study Withdrawal by Subject	1	2
Overall Study Adverse Event	0	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	NCX 470 0.021% n=111 Participants NCX 470 Ophthalmic Solution, 0.021% dosed once daily for 4 weeks NCX 470: NCX 470 Ophthalmic Solution	NCX 470 0.042% n=108 Participants NCX 470 Ophthalmic Solution, 0.042% dosed once daily for 4 weeks NCX 470: NCX 470 Ophthalmic Solution	NCX 470 0.065% n=107 Participants NCX 470 Ophthalmic Solution, 0.065% dosed once daily for 4 weeks NCX 470: NCX 470 Ophthalmic Solution	Latanoprost 0.005% n=107 Participants Latanoprost Ophthalmic Solution, 0.005% dosed once daily for 4 weeks Latanoprost 0.005%: Latanoprost 0.005% Ophthalmic Solution	Total n=433 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	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	48 Participants n=5 Participants	46 Participants n=7 Participants	53 Participants n=5 Participants	55 Participants n=4 Participants	202 Participants n=21 Participants
Age, Categorical >=65 years	63 Participants n=5 Participants	62 Participants n=7 Participants	54 Participants n=5 Participants	52 Participants n=4 Participants	231 Participants n=21 Participants
Sex: Female, Male Female	54 Participants n=5 Participants	71 Participants n=7 Participants	58 Participants n=5 Participants	57 Participants n=4 Participants	240 Participants n=21 Participants
Sex: Female, Male Male	57 Participants n=5 Participants	37 Participants n=7 Participants	49 Participants n=5 Participants	50 Participants n=4 Participants	193 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	23 Participants n=5 Participants	20 Participants n=7 Participants	16 Participants n=5 Participants	18 Participants n=4 Participants	77 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	88 Participants n=5 Participants	88 Participants n=7 Participants	91 Participants n=5 Participants	89 Participants n=4 Participants	356 Participants n=21 Participants
Ethnicity (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	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	7 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	35 Participants n=5 Participants	32 Participants n=7 Participants	32 Participants n=5 Participants	35 Participants n=4 Participants	134 Participants n=21 Participants
Race (NIH/OMB) White	72 Participants n=5 Participants	74 Participants n=7 Participants	71 Participants n=5 Participants	70 Participants n=4 Participants	287 Participants n=21 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	4 Participants n=21 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	0 Participants n=21 Participants
Region of Enrollment United States	111 Participants n=5 Participants	108 Participants n=7 Participants	107 Participants n=5 Participants	107 Participants n=4 Participants	433 Participants n=21 Participants
Study Eye Baseline Mean Diurnal IOP (mmHg)	26.62 mmHg STANDARD_DEVIATION 1.663 • n=5 Participants	26.89 mmHg STANDARD_DEVIATION 1.987 • n=7 Participants	26.80 mmHg STANDARD_DEVIATION 2.069 • n=5 Participants	26.68 mmHg STANDARD_DEVIATION 1.745 • n=4 Participants	26.75 mmHg STANDARD_DEVIATION 1.866 • n=21 Participants

PRIMARY outcome

Timeframe: Baseline, Week 4

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

Outcome measures

Outcome measures
Measure	NCX 470 0.021% n=110 study eyes Participants received NCX 470 0.021% once daily in both eyes	NCX 470 0.042% n=105 study eyes Participants received NCX 470 0.042% once daily in both eyes	NCX 470 0.065% n=102 study eyes Participants received NCX 470 0.065% once daily in both eyes	Latanoprost 0.005% n=107 study eyes Participants received latanoprost 0.005% once daily in both eyes
Change From Baseline in Study Eye Mean Diurnal IOP at the Week 4	-7.79 mmHg Standard Deviation 2.606	-8.28 mmHg Standard Deviation 2.511	-8.70 mmHg Standard Deviation 3.150	-7.41 mmHg Standard Deviation 2.666

SECONDARY outcome

Timeframe: Baseline, week 1, week 2, exit visit

Population: All participants who were randomized and who had diurnal IOP values at the week 1, week 2, exit visits

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)

Outcome measures

Outcome measures
Measure	NCX 470 0.021% n=111 study eyes Participants received NCX 470 0.021% once daily in both eyes	NCX 470 0.042% n=108 study eyes Participants received NCX 470 0.042% once daily in both eyes	NCX 470 0.065% n=107 study eyes Participants received NCX 470 0.065% once daily in both eyes	Latanoprost 0.005% n=107 study eyes Participants received latanoprost 0.005% once daily in both eyes
Change From Baseline in Study Eye Mean Diurnal IOP at Week 1, Week 2, and Exit Visit Week 2	-7.96 mmHg Standard Deviation 2.774	-8.38 mmHg Standard Deviation 2.439	-8.87 mmHg Standard Deviation 2.797	-7.99 mmHg Standard Deviation 2.504
Change From Baseline in Study Eye Mean Diurnal IOP at Week 1, Week 2, and Exit Visit Week 1	-7.73 mmHg Standard Deviation 2.783	-8.15 mmHg Standard Deviation 2.577	-8.66 mmHg Standard Deviation 3.098	-7.54 mmHg Standard Deviation 2.735
Change From Baseline in Study Eye Mean Diurnal IOP at Week 1, Week 2, and Exit Visit Exit Visit	-4.95 mmHg Standard Deviation 3.237	-5.59 mmHg Standard Deviation 2.827	-5.98 mmHg Standard Deviation 3.019	-4.89 mmHg Standard Deviation 3.009

SECONDARY outcome

Timeframe: 4 weeks for adverse events and through 30 days post-treatment for serious adverse events

Population: Safety population defined as all participants who received at least one dose of the study medication during the 4-week treatment period

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

Outcome measures

Outcome measures
Measure	NCX 470 0.021% n=111 Participants Participants received NCX 470 0.021% once daily in both eyes	NCX 470 0.042% n=108 Participants Participants received NCX 470 0.042% once daily in both eyes	NCX 470 0.065% n=107 Participants Participants received NCX 470 0.065% once daily in both eyes	Latanoprost 0.005% n=107 Participants Participants received latanoprost 0.005% once daily in both eyes
Percentage of Subjects With Treatment-emergent Ocular Adverse Events	34 Participants	52 Participants	50 Participants	21 Participants

Adverse Events

NCX 470 0.021%

Serious events: 1 serious events

Other events: 24 other events

Deaths: 0 deaths

NCX 470 0.042%

Serious events: 2 serious events

Other events: 42 other events

Deaths: 0 deaths

NCX 470 0.065%

Serious events: 1 serious events

Other events: 39 other events

Deaths: 0 deaths

Latanoprost 0.005%

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	NCX 470 0.021% n=111 participants at risk NCX 470 Ophthalmic Solution, 0.021% dosed once daily for 4 weeks NCX 470: NCX 470 Ophthalmic Solution	NCX 470 0.042% n=108 participants at risk NCX 470 Ophthalmic Solution, 0.042% dosed once daily for 4 weeks NCX 470: NCX 470 Ophthalmic Solution	NCX 470 0.065% n=107 participants at risk NCX 470 Ophthalmic Solution, 0.065% dosed once daily for 4 weeks NCX 470: NCX 470 Ophthalmic Solution	Latanoprost 0.005% n=107 participants at risk Latanoprost Ophthalmic Solution, 0.005% dosed once daily for 4 weeks Latanoprost 0.005%: Latanoprost 0.005% Ophthalmic Solution
Nervous system disorders Transient ischaemic attack	0.90% 1/111 • Number of events 1 • 29 days with collection of serious adverse events for up to 30 days post study exit	0.00% 0/108 • 29 days with collection of serious adverse events for up to 30 days post study exit	0.00% 0/107 • 29 days with collection of serious adverse events for up to 30 days post study exit	0.00% 0/107 • 29 days with collection of serious adverse events for up to 30 days post study exit
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	0.00% 0/111 • 29 days with collection of serious adverse events for up to 30 days post study exit	0.00% 0/108 • 29 days with collection of serious adverse events for up to 30 days post study exit	0.93% 1/107 • Number of events 1 • 29 days with collection of serious adverse events for up to 30 days post study exit	0.00% 0/107 • 29 days with collection of serious adverse events for up to 30 days post study exit
Eye disorders Endophthalmitis	0.00% 0/111 • 29 days with collection of serious adverse events for up to 30 days post study exit	0.93% 1/108 • Number of events 1 • 29 days with collection of serious adverse events for up to 30 days post study exit	0.00% 0/107 • 29 days with collection of serious adverse events for up to 30 days post study exit	0.00% 0/107 • 29 days with collection of serious adverse events for up to 30 days post study exit
Vascular disorders Hypertension	0.00% 0/111 • 29 days with collection of serious adverse events for up to 30 days post study exit	0.93% 1/108 • Number of events 1 • 29 days with collection of serious adverse events for up to 30 days post study exit	0.00% 0/107 • 29 days with collection of serious adverse events for up to 30 days post study exit	0.00% 0/107 • 29 days with collection of serious adverse events for up to 30 days post study exit

Other adverse events

Other adverse events
Measure	NCX 470 0.021% n=111 participants at risk NCX 470 Ophthalmic Solution, 0.021% dosed once daily for 4 weeks NCX 470: NCX 470 Ophthalmic Solution	NCX 470 0.042% n=108 participants at risk NCX 470 Ophthalmic Solution, 0.042% dosed once daily for 4 weeks NCX 470: NCX 470 Ophthalmic Solution	NCX 470 0.065% n=107 participants at risk NCX 470 Ophthalmic Solution, 0.065% dosed once daily for 4 weeks NCX 470: NCX 470 Ophthalmic Solution	Latanoprost 0.005% n=107 participants at risk Latanoprost Ophthalmic Solution, 0.005% dosed once daily for 4 weeks Latanoprost 0.005%: Latanoprost 0.005% Ophthalmic Solution
Eye disorders Conjunctival hyperaemia	10.8% 12/111 • Number of events 13 • 29 days with collection of serious adverse events for up to 30 days post study exit	22.2% 24/108 • Number of events 25 • 29 days with collection of serious adverse events for up to 30 days post study exit	16.8% 18/107 • Number of events 18 • 29 days with collection of serious adverse events for up to 30 days post study exit	6.5% 7/107 • Number of events 7 • 29 days with collection of serious adverse events for up to 30 days post study exit
Eye disorders Ocular hyperaemia	4.5% 5/111 • Number of events 8 • 29 days with collection of serious adverse events for up to 30 days post study exit	8.3% 9/108 • Number of events 11 • 29 days with collection of serious adverse events for up to 30 days post study exit	9.3% 10/107 • Number of events 12 • 29 days with collection of serious adverse events for up to 30 days post study exit	4.7% 5/107 • Number of events 8 • 29 days with collection of serious adverse events for up to 30 days post study exit
Eye disorders Eye pruritus	1.8% 2/111 • Number of events 2 • 29 days with collection of serious adverse events for up to 30 days post study exit	0.93% 1/108 • Number of events 1 • 29 days with collection of serious adverse events for up to 30 days post study exit	5.6% 6/107 • Number of events 6 • 29 days with collection of serious adverse events for up to 30 days post study exit	0.00% 0/107 • 29 days with collection of serious adverse events for up to 30 days post study exit
General disorders Instillation site pain	7.2% 8/111 • Number of events 8 • 29 days with collection of serious adverse events for up to 30 days post study exit	9.3% 10/108 • Number of events 10 • 29 days with collection of serious adverse events for up to 30 days post study exit	11.2% 12/107 • Number of events 12 • 29 days with collection of serious adverse events for up to 30 days post study exit	5.6% 6/107 • Number of events 6 • 29 days with collection of serious adverse events for up to 30 days post study exit
General disorders Instillation site pruritus	1.8% 2/111 • Number of events 2 • 29 days with collection of serious adverse events for up to 30 days post study exit	4.6% 5/108 • Number of events 5 • 29 days with collection of serious adverse events for up to 30 days post study exit	2.8% 3/107 • Number of events 3 • 29 days with collection of serious adverse events for up to 30 days post study exit	2.8% 3/107 • Number of events 3 • 29 days with collection of serious adverse events for up to 30 days post study exit

Additional Information

Doug Hubatsch / Chief Scientific Officer

Nicox Ophthalmics Inc.

Phone: 832-360-3022

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place