Trial · NCT02981446
A Phase III Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution Compared With Latanoprost Ophthalmic Solution in Subjects With OAG or OHT
NCT02981446, Phase 3, Completed, Santen Pharmaceutical Co., Ltd.; results first posted 2024-03-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase III Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution Compared With Latanoprost Ophthalmic Solution in Subjects With OAG or OHT. Trials, record NCT02981446. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02981446
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase III Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution Compared With Latanoprost Ophthalmic Solution in Subjects With OAG or OHT
- NCT number
- NCT02981446
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 370 participants, actual
- Lead sponsor
- Santen Pharmaceutical Co., Ltd.
- Conditions
- Open Angle Glaucoma or Ocular Hypertension
- Interventions
- DE-117, Latanoprost ophthalmic solution
- First posted
- 2016-12-05
- Last updated
- 2024-03-15
- Results first posted
- 2024-03-15
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Diurnal IOP at Month 3 | Month 3 (average of IOP at 3 time points: 09:00, 13:00, 17:00) | The IOP (mmHg) measured in the study eye (identified at Day 1 \[baseline\]) was the efficacy measure for this study. The IOP was measured using a calibrated Goldmann applanation tonometer preferably by the same Investigator (operator) and the same authorized study staff (recorder) during the study for each subject. |
| Secondary | IOP at 9 Timepoints (First Key Secondary Efficacy Endpoint) | 09:00, 13:00, and 17:00 at Week 1, Week 6, and Month 3. | The IOP (mmHg) measured in the study eye (identified at Day 1 \[baseline\]) was the efficacy measure for this study. The IOP was measured using a calibrated Goldmann applanation tonometer preferably by the same Investigator (operator) and the same authorized study staff (recorder) during the study for each subject. |
| Secondary | Mean Diurnal IOP at Week 1 (Second Key Secondary Endpoint) | Week 1 | The IOP (mmHg) measured in the study eye (identified at Day 1 \[baseline\]) was the efficacy measure for this study. The IOP was measured using a calibrated Goldmann applanation tonometer preferably by the same Investigator (operator) and the same authorized study staff (recorder) during the study for each subject. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Diurnal IOP at Month 3 | Month 3 (average of IOP at 3 time points: 09:00, 13:00, 17:00) | One subject in the DE-117 arm was excluded from the FAS due to no data for at least 1 post-baseline IOP measurement. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | IOP at 9 Timepoints (First Key Secondary Efficacy Endpoint) | 09:00, 13:00, and 17:00 at Week 1, Week 6, and Month 3. | One subject in the DE-117 arm was excluded from the FAS due to no data for at least 1 post-baseline IOP measurement. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Diurnal IOP at Week 1 (Second Key Secondary Endpoint) | Week 1 | One subject in the DE-117 arm was excluded from the FAS due to no data for at least 1 post-baseline IOP measurement. | mmHg | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Diurnal IOP at Month 3 | DE-117 Ophthalmic Solution | 17.5 | Standard Error 0.25 | mmHg | |
| Mean Diurnal IOP at Month 3 | Latanoprost Ophthalmic Solution 0.005% | 16.8 | Standard Error 0.25 | mmHg | |
| IOP at 9 Timepoints (First Key Secondary Efficacy Endpoint) | DE-117 Ophthalmic Solution | Week 1 09:00 | 19.0 | Standard Error 0.28 | mmHg |
| IOP at 9 Timepoints (First Key Secondary Efficacy Endpoint) | Latanoprost Ophthalmic Solution 0.005% | Week 1 09:00 | 18.8 | Standard Error 0.29 | mmHg |
| IOP at 9 Timepoints (First Key Secondary Efficacy Endpoint) | DE-117 Ophthalmic Solution | Week 1 13:00 | 18.4 | Standard Error 0.28 | mmHg |
| IOP at 9 Timepoints (First Key Secondary Efficacy Endpoint) | Latanoprost Ophthalmic Solution 0.005% | Week 1 13:00 | 18.4 | Standard Error 0.29 | mmHg |
| IOP at 9 Timepoints (First Key Secondary Efficacy Endpoint) | DE-117 Ophthalmic Solution | Week 1 17:00 | 18.0 | Standard Error 0.28 | mmHg |
| IOP at 9 Timepoints (First Key Secondary Efficacy Endpoint) | Latanoprost Ophthalmic Solution 0.005% | Week 1 17:00 | 18.3 | Standard Error 0.28 | mmHg |
| IOP at 9 Timepoints (First Key Secondary Efficacy Endpoint) | DE-117 Ophthalmic Solution | Week 6 09:00 | 17.8 | Standard Error 0.26 | mmHg |
| IOP at 9 Timepoints (First Key Secondary Efficacy Endpoint) | Latanoprost Ophthalmic Solution 0.005% | Week 6 09:00 | 17.4 | Standard Error 0.26 | mmHg |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | DE-117 Ophthalmic Solution | 185 | |
| Overall Study | STARTED | Latanoprost Ophthalmic Solution 0.005% | 185 | |
| Overall Study | COMPLETED | DE-117 Ophthalmic Solution | 170 | |
| Overall Study | COMPLETED | Latanoprost Ophthalmic Solution 0.005% | 177 | |
| Overall Study | NOT COMPLETED | DE-117 Ophthalmic Solution | 15 | |
| Overall Study | NOT COMPLETED | Latanoprost Ophthalmic Solution 0.005% | 8 |
Source ClinicalTrials.gov
Adverse events166
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 | Conjunctival hyperaemia | Eye disorders | DE-117 Ophthalmic Solution | 22 | 185 | |
| other | Conjunctival hyperaemia | Eye disorders | Latanoprost Ophthalmic Solution 0.005% | 10 | 185 | |
| other | Photophobia | Eye disorders | DE-117 Ophthalmic Solution | 10 | 185 | |
| other | Photophobia | Eye disorders | Latanoprost Ophthalmic Solution 0.005% | 1 | 185 | |
| other | Dry eye | Eye disorders | DE-117 Ophthalmic Solution | 9 | 185 | |
| other | Dry eye | Eye disorders | Latanoprost Ophthalmic Solution 0.005% | 4 | 185 | |
| other | Corneal thickening | Eye disorders | DE-117 Ophthalmic Solution | 7 | 185 | |
| other | Corneal thickening | Eye disorders | Latanoprost Ophthalmic Solution 0.005% | 2 | 185 | |
| other | Eye pain | Eye disorders | DE-117 Ophthalmic Solution | 5 | 185 | |
| other | Eye pain | Eye disorders | Latanoprost Ophthalmic Solution 0.005% | 6 | 185 |
1 to 10 of 166Source ClinicalTrials.gov
See all 166 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | DE-117 Ophthalmic Solution | 0 | 185 |
| Total, all-cause mortality | Latanoprost Ophthalmic Solution 0.005% | 0 | 185 |
| Total, other adverse events | DE-117 Ophthalmic Solution | 74 | 185 |
| Total, other adverse events | Latanoprost Ophthalmic Solution 0.005% | 55 | 185 |
| Total, serious adverse events | DE-117 Ophthalmic Solution | 2 | 185 |
| Total, serious adverse events | Latanoprost Ophthalmic Solution 0.005% | 2 | 185 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| DE-117 Ophthalmic Solution vs Latanoprost Ophthalmic Solution 0.005%: deaths from any cause | Trial comparisons |
| DE-117 Ophthalmic Solution vs Latanoprost Ophthalmic Solution 0.005%: 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/NCT02981446
GET https://conductscience.org/api/trials/v1/NCT02981446/results?page=2