Trial · NCT03237936
Effect of IKERVIS® Eye Drops Once Daily on the Quality of Vision in Dry Eye Disease Patients With Severe Keratitis
NCT03237936, Phase 4, Completed, Santen SAS; results first posted 2024-04-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effect of IKERVIS® Eye Drops Once Daily on the Quality of Vision in Dry Eye Disease Patients With Severe Keratitis. Trials, record NCT03237936. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03237936
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of IKERVIS® Eye Drops Once Daily on the Quality of Vision in Dry Eye Disease Patients With Severe Keratitis
- NCT number
- NCT03237936
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 17 participants, actual
- Lead sponsor
- Santen SAS
- Conditions
- Keratitis
- Interventions
- 1mg/mL ciclosporin
- First posted
- 2017-08-03
- Last updated
- 2024-04-18
- Results first posted
- 2024-04-18
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Correlation Between the Change From Baseline in VMR Measured With FVA System at Month 3 and the Change From Baseline in the CFS at Month 3. | at month 3 | Spearman's coefficient of correlation will be calculated at Month 3 between the change from baseline of Corneal Fluorescein Staining (CFS) and respectively the change from baseline of Visual Maintenance Ratio (VRM). |
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 | Correlation Between the Change From Baseline in VMR Measured With FVA System at Month 3 and the Change From Baseline in the CFS at Month 3. | at month 3 | Spearman's coefficient of correlation | NUMBER |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Correlation Between the Change From Baseline in VMR Measured With FVA System at Month 3 and the Change From Baseline in the CFS at Month 3. | IKERVIS® (1mg/mL Ciclosporin) Eye Drops | -0.7028 | 95% Confidence Interval -0.8797 to -0.3158 | Spearman's coefficient of correlation |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | IKERVIS® (1mg/mL Ciclosporin) Eye Drops | 17 | |
| Overall Study | COMPLETED | IKERVIS® (1mg/mL Ciclosporin) Eye Drops | 16 | |
| Overall Study | NOT COMPLETED | IKERVIS® (1mg/mL Ciclosporin) Eye Drops | 1 |
Source ClinicalTrials.gov
Adverse events6
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 | EYE IRRITATION | Eye disorders | IKERVIS® (1mg/mL Ciclosporin) Eye Drops | 3 | 17 | |
| other | DRY EYE | Eye disorders | IKERVIS® (1mg/mL Ciclosporin) Eye Drops | 2 | 17 | |
| other | EYE BURNS | Eye disorders | IKERVIS® (1mg/mL Ciclosporin) Eye Drops | 1 | 17 | |
| other | EYELID OEDEMA | Eye disorders | IKERVIS® (1mg/mL Ciclosporin) Eye Drops | 1 | 17 | |
| other | PHOTOPHOBIA | Eye disorders | IKERVIS® (1mg/mL Ciclosporin) Eye Drops | 1 | 17 | |
| other | VISUAL ACUITY REDUCED | Eye disorders | IKERVIS® (1mg/mL Ciclosporin) Eye Drops | 1 | 17 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | IKERVIS® (1mg/mL Ciclosporin) Eye Drops | 0 | 17 |
| Total, other adverse events | IKERVIS® (1mg/mL Ciclosporin) Eye Drops | 9 | 17 |
| Total, serious adverse events | IKERVIS® (1mg/mL Ciclosporin) Eye Drops | 0 | 17 |
Source ClinicalTrials.gov
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.
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/NCT03237936
GET https://conductscience.org/api/trials/v1/NCT03237936/registered