Trial · NCT04498169
A Phase 2 Study Evaluating the Safety and Efficacy of Netarsudil Ophthalmic Solution in Patients With Corneal Edema Due to Fuchs Corneal Dystrophy
NCT04498169, Phase 2, Completed, Aerie Pharmaceuticals; results first posted 2022-09-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase 2 Study Evaluating the Safety and Efficacy of Netarsudil Ophthalmic Solution in Patients With Corneal Edema Due to Fuchs Corneal Dystrophy. Trials, record NCT04498169. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04498169
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 2 Study Evaluating the Safety and Efficacy of Netarsudil Ophthalmic Solution in Patients With Corneal Edema Due to Fuchs Corneal Dystrophy
- NCT number
- NCT04498169
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 40 participants, actual
- Lead sponsor
- Aerie Pharmaceuticals
- Conditions
- Corneal Edema
- Interventions
- Netarsudil Ophthalmic, Netarsudil Ophthalmic
- First posted
- 2020-08-04
- Last updated
- 2022-09-15
- Results first posted
- 2022-09-01
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Central Corneal Thickness (CCT) | Baseline & 4 weeks | Mean change from baseline in CCT by ultrasound pachymetry |
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 | Central Corneal Thickness (CCT) | Baseline & 4 weeks | Modified Intent-to-Treat Population | µm | MEAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Central Corneal Thickness (CCT) | Once Daily Netarsudil Ophthalmic Solution | -28.4 | Standard Deviation 35.72 | µm | |
| Central Corneal Thickness (CCT) | Twice Daily Netarsudil Ophthalmic Solution | -20.1 | Standard Deviation 39.12 | µm |
Source ClinicalTrials.gov
Participant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Modified Intent-to-Treat Population | STARTED | Once Daily Netarsudil Ophthalmic Solution | 20 | |
| Modified Intent-to-Treat Population | STARTED | Twice Daily Netarsudil Ophthalmic Solution | 20 | |
| Modified Intent-to-Treat Population | COMPLETED | Once Daily Netarsudil Ophthalmic Solution | 19 | |
| Modified Intent-to-Treat Population | COMPLETED | Twice Daily Netarsudil Ophthalmic Solution | 19 | |
| Modified Intent-to-Treat Population | NOT COMPLETED | Once Daily Netarsudil Ophthalmic Solution | 1 | |
| Modified Intent-to-Treat Population | NOT COMPLETED | Twice Daily Netarsudil Ophthalmic Solution | 1 | |
| Safety Population | STARTED | Once Daily Netarsudil Ophthalmic Solution | 20 | |
| Safety Population | STARTED | Twice Daily Netarsudil Ophthalmic Solution | 20 | |
| Safety Population | COMPLETED | Once Daily Netarsudil Ophthalmic Solution | 19 | |
| Safety Population | COMPLETED | Twice Daily Netarsudil Ophthalmic Solution | 19 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events8
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 | Corneal verticillata | Eye disorders | Once Daily Netarsudil Ophthalmic Solution | 3 | 20 | 3 |
| other | Corneal verticillata | Eye disorders | Twice Daily Netarsudil Ophthalmic Solution | 2 | 20 | 2 |
| other | Conjunctival hypaeremia | Eye disorders | Once Daily Netarsudil Ophthalmic Solution | 2 | 20 | 4 |
| other | Conjunctival hypaeremia | Eye disorders | Twice Daily Netarsudil Ophthalmic Solution | 4 | 20 | 4 |
| other | Erythema of eyelid | Eye disorders | Once Daily Netarsudil Ophthalmic Solution | 0 | 20 | 0 |
| other | Erythema of eyelid | Eye disorders | Twice Daily Netarsudil Ophthalmic Solution | 2 | 20 | 2 |
| serious | Viral gastroenteritis | Gastrointestinal disorders | Once Daily Netarsudil Ophthalmic Solution | 0 | 20 | 0 |
| serious | Viral gastroenteritis | Gastrointestinal disorders | Twice Daily Netarsudil Ophthalmic Solution | 1 | 20 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Once Daily Netarsudil Ophthalmic Solution | 0 | 20 |
| Total, all-cause mortality | Twice Daily Netarsudil Ophthalmic Solution | 0 | 20 |
| Total, other adverse events | Once Daily Netarsudil Ophthalmic Solution | 5 | 20 |
| Total, other adverse events | Twice Daily Netarsudil Ophthalmic Solution | 7 | 20 |
| Total, serious adverse events | Once Daily Netarsudil Ophthalmic Solution | 0 | 20 |
| Total, serious adverse events | Twice Daily Netarsudil Ophthalmic Solution | 1 | 20 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36327101 | DERIVED |
Source PubMed
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Once Daily Netarsudil Ophthalmic Solution vs Twice Daily Netarsudil Ophthalmic Solution: deaths from any cause | Trial comparisons |
| Once Daily Netarsudil Ophthalmic Solution vs Twice Daily Netarsudil Ophthalmic Solution: serious adverse events | Trial comparisons |
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/NCT04498169
GET https://conductscience.org/api/trials/v1/NCT04498169/flow?page=2