Trial · NCT03697811
DE-117 Spectrum 5 Study
NCT03697811, Phase 3, Completed, Santen Inc.; results first posted 2023-08-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. DE-117 Spectrum 5 Study. Trials, record NCT03697811. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03697811
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- DE-117 Spectrum 5 Study
- NCT number
- NCT03697811
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 107 participants, actual
- Lead sponsor
- Santen Inc.
- Conditions
- Primary Open-angle Glaucoma and Ocular Hypertension
- Interventions
- DE-117 Ophthalmic Solution
- First posted
- 2018-10-05
- Last updated
- 2023-08-30
- Results first posted
- 2023-08-30
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Month 3. | Month 3 | IOP lowering effect of DE-117 ophthalmic solution 0.002% in Latanoprost low/non-responder subjects. Mean Diurnal Intraocular Pressure: Analysis of Change from Baseline in IOP score at Month 3 using Paired T-test on Observed Case. Mean Diurnal IOP is defined as the average IOP of all three timepoints (8:00,12:00, 16:00) at Month 3. |
| Secondary | Percent Change From Baseline in Mean Diurnal IOP at Week 2, Week 6 and Month 3 | week 2, 6 and month 3 | The secondary efficacy endpoint evaluated percent change from baseline in mean DIOP at week 2, 6 and month 3. |
| Secondary | Change From Baseline in Mean Diurnal IOP at Week 2 and Week 6 | week 2 and 6 | Change from baseline (Visit 4) in mean diurnal IOP at Week 2 (Visit 5) and Week 6 (Visit 6). |
| Secondary | Change From Baseline in IOP at Timepoints at Week 2 | 08:00, 12:00 and 16:00 at Week 2 | Change in mean IOP were evaluated at each time point at all post-baseline visits. (Change from baseline measurement at each timepoint was calculated by deducting the baseline value at corresponding timepoint from the IOP measurement). |
| Secondary | Change From Baseline in IOP at Timepoints at Week 6 | 08:00, 12:00 and 16:00 at Week 6 | Change in mean IOP were evaluated at each time point at all post-baseline visits. |
| Secondary | Change From Baseline in IOP at Timepoints at Month 3 | 08:00, 12:00 and 16:00 at month 3 | Change in mean IOP were evaluated at each time point at all post-baseline visits. |
| Secondary | Intraocular Pressure: Percent Change From Baseline by Analysis Visit and Timepoint at Week 2 | 08:00, 12:00 and 16:00 at week 2 | Intraocular Pressure: Percent Change from Baseline by Analysis Visit and Timepoint. |
| Secondary | Intraocular Pressure: Percent Change From Baseline by Analysis Visit and Timepoint at Week 6 | 08:00, 12:00 and 16:00 at week 6 | Intraocular Pressure: Percent Change from Baseline by Analysis Visit and Timepoint. |
| Secondary | Intraocular Pressure: Percent Change From Baseline by Analysis Visit and Timepoint at Month 3 | 08:00, 12:00 and 16:00 at month 3. | Intraocular Pressure: Percent Change from Baseline by Analysis Visit and Timepoint. |
Source ClinicalTrials.gov
Outcomes9
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 Intraocular Pressure (IOP) at Month 3. | Month 3 | Full Analysis Set (observed cases only) | mmHg | MEAN |
| SECONDARY | Percent Change From Baseline in Mean Diurnal IOP at Week 2, Week 6 and Month 3 | week 2, 6 and month 3 | Full Analysis Set (observed cases only). | Percent change | MEAN |
| SECONDARY | Change From Baseline in Mean Diurnal IOP at Week 2 and Week 6 | week 2 and 6 | Full Analysis Set (observed cases only). | mmHg | MEAN |
| SECONDARY | Change From Baseline in IOP at Timepoints at Week 2 | 08:00, 12:00 and 16:00 at Week 2 | Full Analysis Set (observed cases only). | mmHg | MEAN |
| SECONDARY | Change From Baseline in IOP at Timepoints at Week 6 | 08:00, 12:00 and 16:00 at Week 6 | Full Analysis Set (observed cases only) | mmHg | MEAN |
| SECONDARY | Change From Baseline in IOP at Timepoints at Month 3 | 08:00, 12:00 and 16:00 at month 3 | Full Analysis Set (observed cases only). | mmHg | MEAN |
| SECONDARY | Intraocular Pressure: Percent Change From Baseline by Analysis Visit and Timepoint at Week 2 | 08:00, 12:00 and 16:00 at week 2 | Full Analysis Set (observed cases only). | Percent change | MEAN |
| SECONDARY | Intraocular Pressure: Percent Change From Baseline by Analysis Visit and Timepoint at Week 6 | 08:00, 12:00 and 16:00 at week 6 | Full Analysis Set | Percent change | MEAN |
| SECONDARY | Intraocular Pressure: Percent Change From Baseline by Analysis Visit and Timepoint at Month 3 | 08:00, 12:00 and 16:00 at month 3. | Full Analysis Set (observed cases only). | Percent change | MEAN |
Source ClinicalTrials.gov
Results by group24
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 Intraocular Pressure (IOP) at Month 3. | DE-117 Ophthalmic Solution 0.002% | -2.96 | Standard Deviation 2.831 | mmHg | |
| Percent Change From Baseline in Mean Diurnal IOP at Week 2, Week 6 and Month 3 | DE-117 Ophthalmic Solution 0.002% | Week 2 | -12.21 | Standard Deviation 10.855 | Percent change |
| Percent Change From Baseline in Mean Diurnal IOP at Week 2, Week 6 and Month 3 | DE-117 Ophthalmic Solution 0.002% | Week 6 | -12.40 | Standard Deviation 11.218 | Percent change |
| Percent Change From Baseline in Mean Diurnal IOP at Week 2, Week 6 and Month 3 | DE-117 Ophthalmic Solution 0.002% | Month 3 | -12.57 | Standard Deviation 11.907 | Percent change |
| Change From Baseline in Mean Diurnal IOP at Week 2 and Week 6 | DE-117 Ophthalmic Solution 0.002% | Week 2 | -2.87 | Standard Deviation 2.531 | mmHg |
| Change From Baseline in Mean Diurnal IOP at Week 2 and Week 6 | DE-117 Ophthalmic Solution 0.002% | Week 6 | -2.89 | Standard Deviation 2.578 | mmHg |
| Change From Baseline in IOP at Timepoints at Week 2 | DE-117 Ophthalmic Solution 0.002% | 8:00 | -2.52 | Standard Deviation 2.976 | mmHg |
| Change From Baseline in IOP at Timepoints at Week 2 | DE-117 Ophthalmic Solution 0.002% | 12:00 | -2.94 | Standard Deviation 2.922 | mmHg |
| Change From Baseline in IOP at Timepoints at Week 2 | DE-117 Ophthalmic Solution 0.002% | 16:00 | -3.15 | Standard Deviation 3.077 | mmHg |
| Change From Baseline in IOP at Timepoints at Week 6 | DE-117 Ophthalmic Solution 0.002% | 8:00 | -2.42 | Standard Deviation 3.209 | mmHg |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | DE-117 Ophthalmic Solution 0.002% | 107 | |
| Overall Study | COMPLETED | DE-117 Ophthalmic Solution 0.002% | 104 | |
| Overall Study | NOT COMPLETED | DE-117 Ophthalmic Solution 0.002% | 3 |
Source ClinicalTrials.gov
Adverse events25
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 pain | Eye disorders | DE-117 Ophthalmic Solution 0.002% | 2 | 107 | |
| other | Anterior chamber cell | Eye disorders | DE-117 Ophthalmic Solution 0.002% | 1 | 107 | |
| other | Conjunctival oedema | Eye disorders | DE-117 Ophthalmic Solution 0.002% | 1 | 107 | |
| other | Eye irritation | Eye disorders | DE-117 Ophthalmic Solution 0.002% | 1 | 107 | |
| other | Eyelash hyperpigmentation | Eye disorders | DE-117 Ophthalmic Solution 0.002% | 1 | 107 | |
| other | Macular oedema | Eye disorders | DE-117 Ophthalmic Solution 0.002% | 1 | 107 | |
| other | Photophobia | Eye disorders | DE-117 Ophthalmic Solution 0.002% | 1 | 107 | |
| other | Vision blurred | Eye disorders | DE-117 Ophthalmic Solution 0.002% | 1 | 107 | |
| other | Instillation site foreign body sensation | General disorders | DE-117 Ophthalmic Solution 0.002% | 1 | 107 | |
| other | Instillation site pain | General disorders | DE-117 Ophthalmic Solution 0.002% | 1 | 107 |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | DE-117 Ophthalmic Solution 0.002% | 0 | 107 |
| Total, other adverse events | DE-117 Ophthalmic Solution 0.002% | 27 | 107 |
| Total, serious adverse events | DE-117 Ophthalmic Solution 0.002% | 0 | 107 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37853676 | 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 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/NCT03697811
GET https://conductscience.org/api/trials/v1/NCT03697811/results?page=2