Trial · NCT01342081
DE-111 Against Tafluprost Ophthalmic Solution 0.0015% Alone and Concomitant Use of Tafluprost Ophthalmic Solution 0.0015% Plus Timolol Ophthalmic Solution 0.5%
NCT01342081, Phase 3, Completed, Santen Pharmaceutical Co., Ltd.; results first posted 2015-05-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. DE-111 Against Tafluprost Ophthalmic Solution 0.0015% Alone and Concomitant Use of Tafluprost Ophthalmic Solution 0.0015% Plus Timolol Ophthalmic Solution 0.5%. Trials, record NCT01342081. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01342081
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- DE-111 Against Tafluprost Ophthalmic Solution 0.0015% Alone and Concomitant Use of Tafluprost Ophthalmic Solution 0.0015% Plus Timolol Ophthalmic Solution 0.5%
- NCT number
- NCT01342081
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 489 participants, actual
- Lead sponsor
- Santen Pharmaceutical Co., Ltd.
- Conditions
- Open Angle Glaucoma, Ocular Hypertension
- Interventions
- DE-111 ophthalmic solution, Tafluprost ophthalmic solution 0.0015%, Concomitant use of tafluprost ophthalmic solution 0.0015% plus timolol ophthalmic solution 0.5%
- First posted
- 2011-04-26
- Last updated
- 2015-06-15
- Results first posted
- 2015-05-14
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Mean Diurnal IOP(Intraocular Pressure) at End of Study | Week 0(Baseline) and Week 4(End of Study) | Mean diurnal IOP(intraocular pressure) was calculated as an average of IOP(intraocular pressure) at 9:30 (pre-dose), 11:30 and 17:30. |
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 | Change From Baseline in Mean Diurnal IOP(Intraocular Pressure) at End of Study | Week 0(Baseline) and Week 4(End of Study) | mmHg | MEAN |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Mean Diurnal IOP(Intraocular Pressure) at End of Study | DE-111 | -2.6 | Standard Deviation 1.8 | mmHg | |
| Change From Baseline in Mean Diurnal IOP(Intraocular Pressure) at End of Study | Tafluprost | -0.9 | Standard Deviation 1.7 | mmHg | |
| Change From Baseline in Mean Diurnal IOP(Intraocular Pressure) at End of Study | Tafluprost Plus Timolol | -2.2 | Standard Deviation 1.8 | mmHg |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | DE-111 | 161 | |
| Overall Study | STARTED | Tafluprost | 164 | |
| Overall Study | STARTED | Tafluprost Plus Timolol | 164 | |
| Overall Study | COMPLETED | DE-111 | 159 | |
| Overall Study | COMPLETED | Tafluprost | 162 | |
| Overall Study | COMPLETED | Tafluprost Plus Timolol | 163 | |
| Overall Study | NOT COMPLETED | DE-111 | 2 | |
| Overall Study | NOT COMPLETED | Tafluprost | 2 | |
| Overall Study | NOT COMPLETED | Tafluprost Plus Timolol | 1 |
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 totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | DE-111 | ||
| Total, all-cause mortality | Tafluprost | ||
| Total, all-cause mortality | Tafluprost Plus Timolol | ||
| Total, other adverse events | DE-111 | 0 | 161 |
| Total, other adverse events | Tafluprost | 0 | 164 |
| Total, other adverse events | Tafluprost Plus Timolol | 0 | 163 |
| Total, serious adverse events | DE-111 | 0 | 161 |
| Total, serious adverse events | Tafluprost | 0 | 164 |
| Total, serious adverse events | Tafluprost Plus Timolol | 0 | 163 |
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/NCT01342081
GET https://conductscience.org/api/trials/v1/NCT01342081/registered