Trial · NCT01240382
Phase III Confirmatory Study of DE-089 Ophthalmic Solution in Patients With Dry Eye
NCT01240382, Phase 3, Completed, Santen Pharmaceutical Co., Ltd.; results first posted 2014-08-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase III Confirmatory Study of DE-089 Ophthalmic Solution in Patients With Dry Eye. Trials, record NCT01240382. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01240382
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase III Confirmatory Study of DE-089 Ophthalmic Solution in Patients With Dry Eye
- NCT number
- NCT01240382
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 332 participants, actual
- Lead sponsor
- Santen Pharmaceutical Co., Ltd.
- Conditions
- Dry Eye
- Interventions
- 3% DE-089 ophthalmic solution, 0.1% sodium hyaluronate ophthalmic solution
- First posted
- 2010-11-15
- Last updated
- 2014-08-13
- Results first posted
- 2014-08-08
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change in Fluorescein Staining Score From Baseline | Baseline and 4-week (discontinued (LOCF)) | Fluorescein staining was scored according to the protocol by Shimmura et al. The cornea was divided into 3 equal zones: upper, middle, and lower. Each zone had a staining score ranging between 0 and 3 points, with minimum and maximum total staining scores ranging between 0 and 9 points. 0 is better. The degree of staining with Fluorescein dyes was scored as follows: 0 = no staining, 1= staining of less than half of the area, 2= staining of more than half of the area, 3= staining in the whole area. |
| Primary | Mean Change in Rose Bengal Staining Score From Baseline | Baseline and 4-week (discontinued (LOCF)) | Rose bengal staining were scored according to the protocol by Shimmura et al. The ocular surface was divided into 5 zones: nasal and temporal conjunctival, and upper, middle, and lower corneal areas. A staining score between 0 and 3 points was used in each zone, with the minimum and maximum total staining scores ranging between 0 and 15 points.0 is better. The degree of staining with Rose bengal dyes was scored as follows: 0 = no staining, 1= staining of less than half of the area, 2= staining of more than half of the area, 3= staining in the whole area. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change in Fluorescein Staining Score From Baseline | Baseline and 4-week (discontinued (LOCF)) | Efficacy analysis was performed full analysis set (FAS). In 0.1% sodium hyaluronate ophthalmic solution group, 1 subject was excluded from analysis because there was no available efficacy data in fluorescein staining. | points | MEAN |
| PRIMARY | Mean Change in Rose Bengal Staining Score From Baseline | Baseline and 4-week (discontinued (LOCF)) | Efficacy analysis was performed full analysis set (FAS). In 0.1% sodium hyaluronate ophthalmic solution group, 2 subjects were excluded from analysis because there was no available efficacy data in rose bengal staining. | points | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change in Fluorescein Staining Score From Baseline | 3% DE-089 | -2.12 | Standard Deviation 1.66 | points | |
| Mean Change in Fluorescein Staining Score From Baseline | 0.1% HA | -2.08 | Standard Deviation 1.52 | points | |
| Mean Change in Rose Bengal Staining Score From Baseline | 3% DE-089 | -3.06 | Standard Deviation 2.27 | points | |
| Mean Change in Rose Bengal Staining Score From Baseline | 0.1% HA | -2.38 | Standard Deviation 2.08 | points |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 3% DE-089 | 144 | |
| Overall Study | STARTED | 0.1% HA | 143 | |
| Overall Study | COMPLETED | 3% DE-089 | 142 | |
| Overall Study | COMPLETED | 0.1% HA | 139 | |
| Overall Study | NOT COMPLETED | 3% DE-089 | 2 | |
| Overall Study | NOT COMPLETED | 0.1% HA | 4 |
Source ClinicalTrials.gov
Adverse events4
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 | 3% DE-089 | 9 | 144 | |
| other | Eye irritation | Eye disorders | 0.1% HA | 1 | 143 | |
| serious | Gastrointestinal bleeding | Gastrointestinal disorders | 3% DE-089 | 0 | 144 | |
| serious | Gastrointestinal bleeding | Gastrointestinal disorders | 0.1% HA | 1 | 143 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 3% DE-089 | ||
| Total, all-cause mortality | 0.1% HA | ||
| Total, other adverse events | 3% DE-089 | 9 | 144 |
| Total, other adverse events | 0.1% HA | 1 | 143 |
| Total, serious adverse events | 3% DE-089 | 0 | 144 |
| Total, serious adverse events | 0.1% HA | 1 | 143 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22914501 | 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| 3% DE-089 vs 0.1% HA: serious adverse events |
Source 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/NCT01240382
GET https://conductscience.org/api/trials/v1/NCT01240382/registered