Trial · NCT01165450
Efficacy and Safety Study of Nexagon for Persistent Corneal Epithelial Defects
NCT01165450, Phase 2, Terminated, University of California, San Francisco; results first posted 2015-04-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety Study of Nexagon for Persistent Corneal Epithelial Defects. Trials, record NCT01165450. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01165450
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study of Nexagon for Persistent Corneal Epithelial Defects
- NCT number
- NCT01165450
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 2 participants, actual
- Lead sponsor
- University of California, San Francisco
- Conditions
- Persistent Corneal Epithelial Defects
- Interventions
- Nexagon, Vehicle only
- First posted
- 2010-07-19
- Last updated
- 2015-05-07
- Results first posted
- 2015-04-20
- Limitations and caveats
- The study was terminated prematurely due to discontinued supply of study drug, and data were never analyzed; PI has left the institution and data are no longer available.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Healing of the Corneal Epithelial Defect at Day 14 ± 1 in the Study Eye | 14 ± 1 days | Primary efficacy measure: To determine whether topical treatment of persistent epithelial defects with Nexagon preparations yields greater healing at Day 14 ± 1, compared to vehicle alone, in individuals having had diabetic vitrectomy. Healing will be determined by comparing pseudo-area (as measured by Investigator, or designated ophthalmologist) at baseline (taken just prior to the first treatment) and Day 14 ± 1. Pseudo-area is defined by the longest diameter of the lesion multiplied by the longest perpendicular to this longest diameter. |
| Primary | Incidence of Adverse Events Following Application of the Investigational Product in All Subjects | 28 ± 2 days | Primary safety measure: To determine incidence of adverse events by recording their occurrence at each study visit through Day 28 ± 2. Analysis of safety data will be performed prior to each dose-escalation. If greater than 2 serious adverse events are found that are causally related to the investigational product, the study will be halted. |
| Secondary | Time to Complete Re-epithelialization of the Study Eye | 28 ± 2 days | Resolution of epithelial defect is defined as the largest diameter of the epithelial defect being less than 0.5 mm, as it is difficult to distinguish a smaller defect from the small amount of fluorescing staining seen in a healed defect. Time of complete re-epithelialization will be defined as the midpoint between the last observed date with an epithelial defect and the date of the first visit with no epithelial defect, up to Day 28 ± 2. |
| Secondary | Complete Healing of the Corneal Epithelial Defect at Day 14 ± 1 in the Study Eye | 14 ± 1 days | To determine binary indicator of whether or not healing has occurred at 14 ± 1 days, defined as the largest diameter of the epithelial defect being smaller than 0.5 mm as determined by slit lamp examination with fluorescein staining. |
| Secondary | Change in the Rate of Re-epithelialization of the Study Eye | 35 ± 2 days | To determine the change in the rate of re-epithelialization of the study eye from the screening run-in period to the treatment period, if applicable. Time Frame: Screening period is defined as Day -7 to Day 0 ± 1. Treatment period is defined as Day 0 ± 1 through time of complete re-epithelialization. Time of complete re-epithelialization is defined as the midpoint between the last observed date with an epithelial defect and the date of the first visit with no epithelial defect, up to Day 28 ± 2. |
| Secondary | Persistence of Complete Corneal Re-epithelialization in the Study Eye | 28 ± 2 days | To determine whether or not complete corneal re-epithelialization was persistent, as determined by whether the healed epithelium remains intact after complete re-epithelialization is confirmed in the study eye. The measurement will be made at Day 28 ± 2. |
| Secondary | Percent Reduction of Corneal Epithelial Defect at Day 28 ± 2 in the Study Eye | 28 ± 2 days | To compare, in each of the two patient populations, the percent reduction in epithelial defect size at Day 28 ± 2 compared to baseline, as measured by slit lamp examination with fluorescein staining. Epithelial defect size determined by pseudo-area, defined by the longest diameter of the lesion multiplied by the longest perpendicular to this longest diameter. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Healing of the Corneal Epithelial Defect at Day 14 ± 1 in the Study Eye | 14 ± 1 days | The study was terminated prematurely, data were never analyzed; PI has left the institution and data are no longer available. | ||
| PRIMARY | Incidence of Adverse Events Following Application of the Investigational Product in All Subjects | 28 ± 2 days | The study was terminated prematurely, data were never analyzed; PI has left the institution and data are no longer available. | ||
| SECONDARY | Time to Complete Re-epithelialization of the Study Eye | 28 ± 2 days | The study was terminated prematurely, data were never analyzed; PI has left the institution and data are no longer available. | ||
| SECONDARY | Complete Healing of the Corneal Epithelial Defect at Day 14 ± 1 in the Study Eye | 14 ± 1 days | The study was terminated prematurely, data were never analyzed; PI has left the institution and data are no longer available. | ||
| SECONDARY | Change in the Rate of Re-epithelialization of the Study Eye | 35 ± 2 days | The study was terminated prematurely, data were never analyzed; PI has left the institution and data are no longer available. | ||
| SECONDARY | Persistence of Complete Corneal Re-epithelialization in the Study Eye | 28 ± 2 days | The study was terminated prematurely, data were never analyzed; PI has left the institution and data are no longer available. | ||
| SECONDARY | Percent Reduction of Corneal Epithelial Defect at Day 28 ± 2 in the Study Eye | 28 ± 2 days | The study was terminated prematurely, data were never analyzed; PI has left the institution and data are no longer available. |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Overall Study | 2 | |
| Overall Study | COMPLETED | Overall Study | 2 | |
| Overall Study | NOT COMPLETED | Overall Study | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Overall Study | ||
| Total, other adverse events | Overall Study | 0 | 2 |
| Total, serious adverse events | Overall Study | 0 | 2 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01FD003708 | A novel therapeutic for the treatment of persistent corneal epithelial defects | JENG, BENNIE H. | UNIVERSITY OF CALIFORNIA, SAN FRANCISCO | FOOD AND DRUG ADMINISTRATION | 2010 |
Source NIH RePORTER
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/NCT01165450
GET https://conductscience.org/api/trials/v1/NCT01165450/registered