Trial · NCT05646719

Safety and Efficacy of Nyxol Eye Drops as a Single Agent and With Adjunctive Low-Dose Pilocarpine Eye Drops in Subjects With Presbyopia

NCT05646719, Phase 3, Completed, Opus Genetics, Inc; results first posted 2025-06-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Efficacy of Nyxol Eye Drops as a Single Agent and With Adjunctive Low-Dose Pilocarpine Eye Drops in Subjects With Presbyopia. Trials, record NCT05646719. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05646719

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety and Efficacy of Nyxol Eye Drops as a Single Agent and With Adjunctive Low-Dose Pilocarpine Eye Drops in Subjects With Presbyopia
NCT number: NCT05646719
Status: Completed
Phases: Phase 3
Enrollment: 333 participants, actual
Lead sponsor: Opus Genetics, Inc
Conditions: Presbyopia
Interventions: Phentolamine Opthalmic Solution 0.75%, Placebo, Low dose pilocarpine, Low dose pilocarpine vehicle
First posted: 2022-12-12
Last updated: 2026-10-30
Results first posted: 2025-06-03

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	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	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)	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).

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	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	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)	Modified Intent to treat	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
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	Nyxol + Low Dose Pilocarpine	27	Participants
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	Nyxol + Low Dose Pilocarpine Vehicle	31	Participants
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	Placebo + Low Dose Pilocarpine	16	Participants
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	Placebo + Low Dose Pilocarpine Vehicle	22	Participants

Source ClinicalTrials.gov

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Nyxol + Low Dose Pilocarpine	83
Overall Study	STARTED	Nyxol + Low Dose Pilocarpine Vehicle	84
Overall Study	STARTED	Placebo + Low Dose Pilocarpine	83
Overall Study	STARTED	Placebo + Low Dose Pilocarpine Vehicle	83
Overall Study	COMPLETED	Nyxol + Low Dose Pilocarpine	78
Overall Study	COMPLETED	Nyxol + Low Dose Pilocarpine Vehicle	80
Overall Study	COMPLETED	Placebo + Low Dose Pilocarpine	79
Overall Study	COMPLETED	Placebo + Low Dose Pilocarpine Vehicle	82
Overall Study	NOT COMPLETED	Nyxol + Low Dose Pilocarpine	5
Overall Study	NOT COMPLETED	Nyxol + Low Dose Pilocarpine Vehicle	4

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events72

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Instillation site erythema	General disorders	Nyxol + Low Dose Pilocarpine	1	79	1
other	Instillation site erythema	General disorders	Nyxol + Low Dose Pilocarpine Vehicle	1	80	1
other	Instillation site erythema	General disorders	Placebo + Low Dose Pilocarpine	0	81	0
other	Instillation site erythema	General disorders	Placebo + Low Dose Pilocarpine Vehicle	0	82	0
other	Instillation site foreign body sensation	General disorders	Nyxol + Low Dose Pilocarpine	1	79	1
other	Instillation site foreign body sensation	General disorders	Nyxol + Low Dose Pilocarpine Vehicle	0	80	0
other	Instillation site foreign body sensation	General disorders	Placebo + Low Dose Pilocarpine	0	81	0
other	Instillation site foreign body sensation	General disorders	Placebo + Low Dose Pilocarpine Vehicle	0	82	0
other	Instillation site irritation	General disorders	Nyxol + Low Dose Pilocarpine	9	79	9
other	Instillation site irritation	General disorders	Nyxol + Low Dose Pilocarpine Vehicle	9	80	9

1 to 10 of 72Source ClinicalTrials.gov

See all 72 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Nyxol + Low Dose Pilocarpine	0	79
Total, all-cause mortality	Nyxol + Low Dose Pilocarpine Vehicle	0	80
Total, all-cause mortality	Placebo + Low Dose Pilocarpine	0	81
Total, all-cause mortality	Placebo + Low Dose Pilocarpine Vehicle	0	82
Total, other adverse events	Nyxol + Low Dose Pilocarpine	13	79
Total, other adverse events	Nyxol + Low Dose Pilocarpine Vehicle	12	80
Total, other adverse events	Placebo + Low Dose Pilocarpine	18	81
Total, other adverse events	Placebo + Low Dose Pilocarpine Vehicle	13	82
Total, serious adverse events	Nyxol + Low Dose Pilocarpine	0	79
Total, serious adverse events	Nyxol + Low Dose Pilocarpine Vehicle	0	80

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT05646719

GET https://conductscience.org/api/trials/v1/NCT05646719/events?page=2

API reference For AI assistants