Trial Outcomes & Findings for Safety and Efficacy of Nyxol Eye Drops as a Single Agent and With Adjunctive Low-Dose Pilocarpine Eye Drops in Subjects With Presbyopia (NCT NCT05646719)
NCT ID: NCT05646719
Last Updated: 2026-03-12
Results Overview
The primary efficacy endpoint is the percent of subjects with ≥ 15 letters of improvement in photopic binocular DCNVA and with \< 5 letters of loss in photopic binocular BCDVA from Baseline at 30 min post-LDP/vehicle comparing subjects treated with Nyxol + LDP to subjects treated with placebo + LDP vehicle at Visit 5 (Stage 2 Day 8).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
333 participants
Primary outcome timeframe
Baseline at 30 min post-LDP/vehicle comparing subjects treated with Nyxol + LDP to subjects treated with placebo + LDP vehicle at Visit 5 (Stage 2 Day 8)
Results posted on
2026-03-12
Participant Flow
Participant milestones
| Measure |
Nyxol + Low Dose Pilocarpine
Phentolamine Opthalmic Solution 0.75%: phentolamine ophthalmic solution 0.75% (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist
Low dose pilocarpine: Pilocarpine hydrochloride ophthalmic solution 0.4%
|
Nyxol + Low Dose Pilocarpine Vehicle
Phentolamine Opthalmic Solution 0.75%: phentolamine ophthalmic solution 0.75% (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist
Low dose pilocarpine vehicle: Vehicle for low dose pilocarpine
|
Placebo + Low Dose Pilocarpine
Placebo: Vehicle for Phentolamine Ophthalmic Solution
Low dose pilocarpine: Pilocarpine hydrochloride ophthalmic solution 0.4%
|
Placebo + Low Dose Pilocarpine Vehicle
Placebo: Vehicle for Phentolamine Ophthalmic Solution
Low dose pilocarpine vehicle: Vehicle for low dose pilocarpine
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
83
|
84
|
83
|
83
|
|
Overall Study
COMPLETED
|
78
|
80
|
79
|
82
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
4
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Modified intent to treat population used
Baseline characteristics by cohort
| Measure |
Nyxol + Low Dose Pilocarpine
n=82 Participants
Phentolamine Opthalmic Solution 0.75%: phentolamine ophthalmic solution 0.75% (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist
Low dose pilocarpine: Pilocarpine hydrochloride ophthalmic solution 0.4%
|
Nyxol + Low Dose Pilocarpine Vehicle
n=81 Participants
Phentolamine Opthalmic Solution 0.75%: phentolamine ophthalmic solution 0.75% (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist
Low dose pilocarpine vehicle: Vehicle for low dose pilocarpine
|
Placebo + Low Dose Pilocarpine
n=82 Participants
Placebo: Vehicle for Phentolamine Ophthalmic Solution
Low dose pilocarpine: Pilocarpine hydrochloride ophthalmic solution 0.4%
|
Placebo + Low Dose Pilocarpine Vehicle
n=82 Participants
Placebo: Vehicle for Phentolamine Ophthalmic Solution
Low dose pilocarpine vehicle: Vehicle for low dose pilocarpine
|
Total
n=327 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
54.2 years
STANDARD_DEVIATION 5.22 • n=9 Participants • Modified intent to treat population used
|
55.4 years
STANDARD_DEVIATION 5.15 • n=9 Participants • Modified intent to treat population used
|
54.3 years
STANDARD_DEVIATION 5.92 • n=18 Participants • Modified intent to treat population used
|
54.4 years
STANDARD_DEVIATION 4.99 • n=15 Participants • Modified intent to treat population used
|
54.6 years
STANDARD_DEVIATION 5.33 • n=60 Participants • Modified intent to treat population used
|
|
Sex: Female, Male
Female
|
56 Participants
n=9 Participants
|
55 Participants
n=9 Participants
|
64 Participants
n=18 Participants
|
61 Participants
n=15 Participants
|
236 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=9 Participants
|
26 Participants
n=9 Participants
|
18 Participants
n=18 Participants
|
21 Participants
n=15 Participants
|
91 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=9 Participants
|
11 Participants
n=9 Participants
|
12 Participants
n=18 Participants
|
18 Participants
n=15 Participants
|
56 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
67 Participants
n=9 Participants
|
70 Participants
n=9 Participants
|
70 Participants
n=18 Participants
|
64 Participants
n=15 Participants
|
271 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=18 Participants
|
0 Participants
n=15 Participants
|
2 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=9 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
3 Participants
n=15 Participants
|
5 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=9 Participants
|
16 Participants
n=9 Participants
|
15 Participants
n=18 Participants
|
10 Participants
n=15 Participants
|
57 Participants
n=60 Participants
|
|
Race (NIH/OMB)
White
|
64 Participants
n=9 Participants
|
64 Participants
n=9 Participants
|
65 Participants
n=18 Participants
|
69 Participants
n=15 Participants
|
262 Participants
n=60 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=18 Participants
|
0 Participants
n=15 Participants
|
1 Participants
n=60 Participants
|
|
Region of Enrollment
United States
|
82 participants
n=9 Participants
|
81 participants
n=9 Participants
|
82 participants
n=18 Participants
|
82 participants
n=15 Participants
|
327 participants
n=60 Participants
|
PRIMARY outcome
Timeframe: Baseline at 30 min post-LDP/vehicle comparing subjects treated with Nyxol + LDP to subjects treated with placebo + LDP vehicle at Visit 5 (Stage 2 Day 8)Population: Modified Intent to treat
The primary efficacy endpoint is the percent of subjects with ≥ 15 letters of improvement in photopic binocular DCNVA and with \< 5 letters of loss in photopic binocular BCDVA from Baseline at 30 min post-LDP/vehicle comparing subjects treated with Nyxol + LDP to subjects treated with placebo + LDP vehicle at Visit 5 (Stage 2 Day 8).
Outcome measures
| Measure |
Nyxol + Low Dose Pilocarpine
n=78 Participants
Phentolamine Opthalmic Solution 0.75%: phentolamine ophthalmic solution 0.75% (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist
Low dose pilocarpine: Pilocarpine hydrochloride ophthalmic solution 0.4%
|
Nyxol + Low Dose Pilocarpine Vehicle
n=80 Participants
Phentolamine Opthalmic Solution 0.75%: phentolamine ophthalmic solution 0.75% (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist
Low dose pilocarpine vehicle: Vehicle for low dose pilocarpine
|
Placebo + Low Dose Pilocarpine
n=79 Participants
Placebo: Vehicle for Phentolamine Ophthalmic Solution
Low dose pilocarpine: Pilocarpine hydrochloride ophthalmic solution 0.4%
|
Placebo + Low Dose Pilocarpine Vehicle
n=82 Participants
Placebo: Vehicle for Phentolamine Ophthalmic Solution
Low dose pilocarpine vehicle: Vehicle for low dose pilocarpine
|
|---|---|---|---|---|
|
Percent of Subjects With ≥ 15 Letters of Improvement in Photopic Binocular DCNVA and With < 5 Letters of Loss in Photopic Binocular BCDVA in Nyxol-treated Subjects
|
27 Participants
|
31 Participants
|
16 Participants
|
22 Participants
|
Adverse Events
Nyxol + Low Dose Pilocarpine
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Nyxol + Low Dose Pilocarpine Vehicle
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Placebo + Low Dose Pilocarpine
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Placebo + Low Dose Pilocarpine Vehicle
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Nyxol + Low Dose Pilocarpine
n=79 participants at risk
Phentolamine Opthalmic Solution 0.75%: phentolamine ophthalmic solution 0.75% (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist
Low dose pilocarpine: Pilocarpine hydrochloride ophthalmic solution 0.4%
|
Nyxol + Low Dose Pilocarpine Vehicle
n=80 participants at risk
Phentolamine Opthalmic Solution 0.75%: phentolamine ophthalmic solution 0.75% (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist
Low dose pilocarpine vehicle: Vehicle for low dose pilocarpine
|
Placebo + Low Dose Pilocarpine
n=81 participants at risk
Placebo: Vehicle for Phentolamine Ophthalmic Solution
Low dose pilocarpine: Pilocarpine hydrochloride ophthalmic solution 0.4%
|
Placebo + Low Dose Pilocarpine Vehicle
n=82 participants at risk
Placebo: Vehicle for Phentolamine Ophthalmic Solution
Low dose pilocarpine vehicle: Vehicle for low dose pilocarpine
|
|---|---|---|---|---|
|
Eye disorders
Conjunctival oedema
|
0.00%
0/79 • Through study completion; approximately 43 days.
Study used clinicaltrials.gov definitions
|
1.2%
1/80 • Number of events 1 • Through study completion; approximately 43 days.
Study used clinicaltrials.gov definitions
|
0.00%
0/81 • Through study completion; approximately 43 days.
Study used clinicaltrials.gov definitions
|
0.00%
0/82 • Through study completion; approximately 43 days.
Study used clinicaltrials.gov definitions
|
|
Eye disorders
Eye irritation
|
0.00%
0/79 • Through study completion; approximately 43 days.
Study used clinicaltrials.gov definitions
|
0.00%
0/80 • Through study completion; approximately 43 days.
Study used clinicaltrials.gov definitions
|
1.2%
1/81 • Number of events 1 • Through study completion; approximately 43 days.
Study used clinicaltrials.gov definitions
|
0.00%
0/82 • Through study completion; approximately 43 days.
Study used clinicaltrials.gov definitions
|
|
Eye disorders
Vision blurred
|
0.00%
0/79 • Through study completion; approximately 43 days.
Study used clinicaltrials.gov definitions
|
1.2%
1/80 • Number of events 1 • Through study completion; approximately 43 days.
Study used clinicaltrials.gov definitions
|
1.2%
1/81 • Number of events 1 • Through study completion; approximately 43 days.
Study used clinicaltrials.gov definitions
|
0.00%
0/82 • Through study completion; approximately 43 days.
Study used clinicaltrials.gov definitions
|
|
Eye disorders
Visual impairment
|
1.3%
1/79 • Number of events 1 • Through study completion; approximately 43 days.
Study used clinicaltrials.gov definitions
|
0.00%
0/80 • Through study completion; approximately 43 days.
Study used clinicaltrials.gov definitions
|
0.00%
0/81 • Through study completion; approximately 43 days.
Study used clinicaltrials.gov definitions
|
0.00%
0/82 • Through study completion; approximately 43 days.
Study used clinicaltrials.gov definitions
|
|
Nervous system disorders
Headache
|
2.5%
2/79 • Number of events 2 • Through study completion; approximately 43 days.
Study used clinicaltrials.gov definitions
|
1.2%
1/80 • Number of events 1 • Through study completion; approximately 43 days.
Study used clinicaltrials.gov definitions
|
2.5%
2/81 • Number of events 2 • Through study completion; approximately 43 days.
Study used clinicaltrials.gov definitions
|
0.00%
0/82 • Through study completion; approximately 43 days.
Study used clinicaltrials.gov definitions
|
|
Nervous system disorders
Sinus Headache
|
1.3%
1/79 • Number of events 1 • Through study completion; approximately 43 days.
Study used clinicaltrials.gov definitions
|
0.00%
0/80 • Through study completion; approximately 43 days.
Study used clinicaltrials.gov definitions
|
0.00%
0/81 • Through study completion; approximately 43 days.
Study used clinicaltrials.gov definitions
|
0.00%
0/82 • Through study completion; approximately 43 days.
Study used clinicaltrials.gov definitions
|
|
General disorders
Instillation site erythema
|
1.3%
1/79 • Number of events 1 • Through study completion; approximately 43 days.
Study used clinicaltrials.gov definitions
|
1.2%
1/80 • Number of events 1 • Through study completion; approximately 43 days.
Study used clinicaltrials.gov definitions
|
0.00%
0/81 • Through study completion; approximately 43 days.
Study used clinicaltrials.gov definitions
|
0.00%
0/82 • Through study completion; approximately 43 days.
Study used clinicaltrials.gov definitions
|
|
General disorders
Instillation site foreign body sensation
|
1.3%
1/79 • Number of events 1 • Through study completion; approximately 43 days.
Study used clinicaltrials.gov definitions
|
0.00%
0/80 • Through study completion; approximately 43 days.
Study used clinicaltrials.gov definitions
|
0.00%
0/81 • Through study completion; approximately 43 days.
Study used clinicaltrials.gov definitions
|
0.00%
0/82 • Through study completion; approximately 43 days.
Study used clinicaltrials.gov definitions
|
|
General disorders
Instillation site irritation
|
11.4%
9/79 • Number of events 9 • Through study completion; approximately 43 days.
Study used clinicaltrials.gov definitions
|
11.2%
9/80 • Number of events 9 • Through study completion; approximately 43 days.
Study used clinicaltrials.gov definitions
|
16.0%
13/81 • Number of events 13 • Through study completion; approximately 43 days.
Study used clinicaltrials.gov definitions
|
13.4%
11/82 • Number of events 11 • Through study completion; approximately 43 days.
Study used clinicaltrials.gov definitions
|
|
General disorders
Pyrexia
|
0.00%
0/79 • Through study completion; approximately 43 days.
Study used clinicaltrials.gov definitions
|
1.2%
1/80 • Number of events 1 • Through study completion; approximately 43 days.
Study used clinicaltrials.gov definitions
|
0.00%
0/81 • Through study completion; approximately 43 days.
Study used clinicaltrials.gov definitions
|
0.00%
0/82 • Through study completion; approximately 43 days.
Study used clinicaltrials.gov definitions
|
|
Eye disorders
Conjunctival hyperemia
|
1.3%
1/79 • Number of events 1 • Through study completion; approximately 43 days.
Study used clinicaltrials.gov definitions
|
1.2%
1/80 • Number of events 1 • Through study completion; approximately 43 days.
Study used clinicaltrials.gov definitions
|
0.00%
0/81 • Through study completion; approximately 43 days.
Study used clinicaltrials.gov definitions
|
0.00%
0/82 • Through study completion; approximately 43 days.
Study used clinicaltrials.gov definitions
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/79 • Through study completion; approximately 43 days.
Study used clinicaltrials.gov definitions
|
0.00%
0/80 • Through study completion; approximately 43 days.
Study used clinicaltrials.gov definitions
|
2.5%
2/81 • Number of events 2 • Through study completion; approximately 43 days.
Study used clinicaltrials.gov definitions
|
0.00%
0/82 • Through study completion; approximately 43 days.
Study used clinicaltrials.gov definitions
|
|
Infections and infestations
COVID-19
|
0.00%
0/79 • Through study completion; approximately 43 days.
Study used clinicaltrials.gov definitions
|
0.00%
0/80 • Through study completion; approximately 43 days.
Study used clinicaltrials.gov definitions
|
2.5%
2/81 • Number of events 2 • Through study completion; approximately 43 days.
Study used clinicaltrials.gov definitions
|
0.00%
0/82 • Through study completion; approximately 43 days.
Study used clinicaltrials.gov definitions
|
|
Infections and infestations
Sinusitis
|
0.00%
0/79 • Through study completion; approximately 43 days.
Study used clinicaltrials.gov definitions
|
0.00%
0/80 • Through study completion; approximately 43 days.
Study used clinicaltrials.gov definitions
|
0.00%
0/81 • Through study completion; approximately 43 days.
Study used clinicaltrials.gov definitions
|
1.2%
1/82 • Number of events 1 • Through study completion; approximately 43 days.
Study used clinicaltrials.gov definitions
|
|
Investigations
Intraocular pressure increased
|
0.00%
0/79 • Through study completion; approximately 43 days.
Study used clinicaltrials.gov definitions
|
0.00%
0/80 • Through study completion; approximately 43 days.
Study used clinicaltrials.gov definitions
|
0.00%
0/81 • Through study completion; approximately 43 days.
Study used clinicaltrials.gov definitions
|
1.2%
1/82 • Number of events 1 • Through study completion; approximately 43 days.
Study used clinicaltrials.gov definitions
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/79 • Through study completion; approximately 43 days.
Study used clinicaltrials.gov definitions
|
1.2%
1/80 • Number of events 1 • Through study completion; approximately 43 days.
Study used clinicaltrials.gov definitions
|
0.00%
0/81 • Through study completion; approximately 43 days.
Study used clinicaltrials.gov definitions
|
0.00%
0/82 • Through study completion; approximately 43 days.
Study used clinicaltrials.gov definitions
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/79 • Through study completion; approximately 43 days.
Study used clinicaltrials.gov definitions
|
1.2%
1/80 • Number of events 1 • Through study completion; approximately 43 days.
Study used clinicaltrials.gov definitions
|
0.00%
0/81 • Through study completion; approximately 43 days.
Study used clinicaltrials.gov definitions
|
0.00%
0/82 • Through study completion; approximately 43 days.
Study used clinicaltrials.gov definitions
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/79 • Through study completion; approximately 43 days.
Study used clinicaltrials.gov definitions
|
1.2%
1/80 • Number of events 1 • Through study completion; approximately 43 days.
Study used clinicaltrials.gov definitions
|
0.00%
0/81 • Through study completion; approximately 43 days.
Study used clinicaltrials.gov definitions
|
0.00%
0/82 • Through study completion; approximately 43 days.
Study used clinicaltrials.gov definitions
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60