Trial · NCT04675151
Safety and Efficacy of Nyxol With Pilocarpine Eye Drops in Subjects With Presbyopia
NCT04675151, Phase 2, Completed, Opus Genetics, Inc; results first posted 2023-08-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy of Nyxol With Pilocarpine Eye Drops in Subjects With Presbyopia. Trials, record NCT04675151. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04675151
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Nyxol With Pilocarpine Eye Drops in Subjects With Presbyopia
- NCT number
- NCT04675151
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 150 participants, actual
- Lead sponsor
- Opus Genetics, Inc
- Conditions
- Presbyopia
- Interventions
- Phentolamine Ophthalmic Solution 0.75%, Pilocarpine, Placebo
- First posted
- 2020-12-19
- Last updated
- 2026-10-30
- Results first posted
- 2023-08-02
Source ClinicalTrials.gov
Registered outcomes4
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 | Visit 2 at 1 hour | The primary efficacy endpoint was the percent of subjects with ≥ 15 letters of improvement in photopic binocular DCNVA on Visit 2 at 1 hour with POS + LDP compared to placebo alone. The improvement in binocular DCNVA for each subject was relative to the subject's own baseline value (Visit 1). |
| Secondary | Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline | Visit 2 at 0.5 hours, at 2 hours, at 3 hours, at 4 hours, and at 6 hours | The percentage of subjects with improvement of ≥ 5, ≥ 10, and ≥ 15 letters in DCNVA (photopic) from Baseline at 0.5 hours, at 2 hours, at 3 hours, at 4 hours, and at 6 hours |
| Secondary | Percentage of Subjects With Improvement of ≥ 15 Letters in DCNVA (Photopic) at 1 Hour and With < 5 Letters of Loss in Photopic Binocular BCDVA From Baseline | Visit 2 at 1 hour | The percentage of subjects with improvement of ≥ 15 letters in DCNVA (photopic) at 1 hour and with \< 5 letters of loss in photopic binocular BCDVA from Baseline |
| Secondary | Percentage of Subjects With Improvement in DCIVA (Photopic) From Baseline | Visit 2 at 1 hour, at 3 hours, and at 6 hours | The percentage of subjects with improvement in DCIVA (photopic) from Baseline of ≥ 5, ≥ 10, and ≥ 15 letters |
Source ClinicalTrials.gov
Outcomes4
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 | Visit 2 at 1 hour | percentage of subjects with ≥ 15 letters | NUMBER | |
| SECONDARY | Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline | Visit 2 at 0.5 hours, at 2 hours, at 3 hours, at 4 hours, and at 6 hours | percentage of subjects with improvement | NUMBER | |
| SECONDARY | Percentage of Subjects With Improvement of ≥ 15 Letters in DCNVA (Photopic) at 1 Hour and With < 5 Letters of Loss in Photopic Binocular BCDVA From Baseline | Visit 2 at 1 hour | % of subjects with improvement | NUMBER | |
| SECONDARY | Percentage of Subjects With Improvement in DCIVA (Photopic) From Baseline | Visit 2 at 1 hour, at 3 hours, and at 6 hours | percentage with improvement | NUMBER |
Source ClinicalTrials.gov
Results by group104
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent of Subjects With ≥ 15 Letters of Improvement in Photopic Binocular DCNVA | POS 0.75% First, Then LDP 0.4% | 60.5 | percentage of subjects with ≥ 15 letters | ||
| Percent of Subjects With ≥ 15 Letters of Improvement in Photopic Binocular DCNVA | POS 0.75% First, Then LDP Vehicle | 30.0 | percentage of subjects with ≥ 15 letters | ||
| Percent of Subjects With ≥ 15 Letters of Improvement in Photopic Binocular DCNVA | POS Vehicle First, Then LDP 0.4% | 45.2 | percentage of subjects with ≥ 15 letters | ||
| Percent of Subjects With ≥ 15 Letters of Improvement in Photopic Binocular DCNVA | POS Vehicle First, Then LDP Vehicle | 27.3 | percentage of subjects with ≥ 15 letters | ||
| Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline | POS 0.75% First, Then LDP 0.4% | % of subjects with improvement of ≥ 5 letters from baseline at 0.5 hours | 88.4 | percentage of subjects with improvement | |
| Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline | POS 0.75% First, Then LDP Vehicle | % of subjects with improvement of ≥ 5 letters from baseline at 0.5 hours | 86.7 | percentage of subjects with improvement | |
| Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline | POS Vehicle First, Then LDP 0.4% | % of subjects with improvement of ≥ 5 letters from baseline at 0.5 hours | 74.2 | percentage of subjects with improvement | |
| Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline | POS Vehicle First, Then LDP Vehicle | % of subjects with improvement of ≥ 5 letters from baseline at 0.5 hours | 70.5 | percentage of subjects with improvement | |
| Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline | POS 0.75% First, Then LDP 0.4% | % of subjects with improvement of ≥ 10 letters from baseline at 0.5 hours | 76.7 | percentage of subjects with improvement | |
| Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline | POS 0.75% First, Then LDP Vehicle | % of subjects with improvement of ≥ 10 letters from baseline at 0.5 hours | 50.0 | percentage of subjects with improvement |
1 to 10 of 104Source ClinicalTrials.gov
See all 104 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | POS 0.75% First, Then LDP 0.4% | 44 | |
| Overall Study | STARTED | POS 0.75% First, Then LDP Vehicle | 30 | |
| Overall Study | STARTED | POS Vehicle First, Then LDP 0.4% | 31 | |
| Overall Study | STARTED | POS Vehicle First, Then LDP Vehicle | 45 | |
| Overall Study | COMPLETED | POS 0.75% First, Then LDP 0.4% | 43 | |
| Overall Study | COMPLETED | POS 0.75% First, Then LDP Vehicle | 30 | |
| Overall Study | COMPLETED | POS Vehicle First, Then LDP 0.4% | 31 | |
| Overall Study | COMPLETED | POS Vehicle First, Then LDP Vehicle | 44 | |
| Overall Study | NOT COMPLETED | POS 0.75% First, Then LDP 0.4% | 1 | |
| Overall Study | NOT COMPLETED | POS 0.75% First, Then LDP Vehicle | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events64
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 | POS 0.75% First, Then LDP 0.4% | 6 | 44 | 6 |
| other | Instillation site erythema | General disorders | POS 0.75% First, Then LDP Vehicle | 3 | 30 | 3 |
| other | Instillation site erythema | General disorders | POS Vehicle First, Then LDP 0.4% | 2 | 31 | 2 |
| other | Instillation site erythema | General disorders | POS Vehicle First, Then LDP Vehicle | 0 | 45 | 0 |
| other | Installation site pain | General disorders | POS 0.75% First, Then LDP 0.4% | 4 | 44 | 4 |
| other | Installation site pain | General disorders | POS 0.75% First, Then LDP Vehicle | 3 | 30 | 3 |
| other | Installation site pain | General disorders | POS Vehicle First, Then LDP 0.4% | 0 | 31 | 0 |
| other | Installation site pain | General disorders | POS Vehicle First, Then LDP Vehicle | 1 | 45 | 1 |
| other | Installation site pruritus | General disorders | POS 0.75% First, Then LDP 0.4% | 1 | 44 | 1 |
| other | Installation site pruritus | General disorders | POS 0.75% First, Then LDP Vehicle | 0 | 30 | 0 |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | POS 0.75% First, Then LDP 0.4% | 0 | 44 |
| Total, all-cause mortality | POS 0.75% First, Then LDP Vehicle | 0 | 30 |
| Total, all-cause mortality | POS Vehicle First, Then LDP 0.4% | 0 | 31 |
| Total, all-cause mortality | POS Vehicle First, Then LDP Vehicle | 0 | 45 |
| Total, other adverse events | POS 0.75% First, Then LDP 0.4% | 15 | 44 |
| Total, other adverse events | POS 0.75% First, Then LDP Vehicle | 6 | 30 |
| Total, other adverse events | POS Vehicle First, Then LDP 0.4% | 6 | 31 |
| Total, other adverse events | POS Vehicle First, Then LDP Vehicle | 2 | 45 |
| Total, serious adverse events | POS 0.75% First, Then LDP 0.4% | 0 | 44 |
| Total, serious adverse events | POS 0.75% First, Then LDP Vehicle | 0 | 30 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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.
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/NCT04675151
GET https://conductscience.org/api/trials/v1/NCT04675151/results?page=2