Trial · NCT03691649
A Phase III Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Glaucoma or Ocular Hypertension - Spectrum 3 Study
NCT03691649, Phase 3, Completed, Santen Inc.; results first posted 2023-08-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase III Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Glaucoma or Ocular Hypertension - Spectrum 3 Study. Trials, record NCT03691649. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03691649
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Phase III Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Glaucoma or Ocular Hypertension - Spectrum 3 Study
- NCT number
- NCT03691649
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 426 participants, actual
- Lead sponsor
- Santen Inc.
- Conditions
- Glaucoma and Ocular Hypertension
- Interventions
- DE-117 Ophthalmic Solution, Timolol Maleate Ophthalmic Solution 0.5%
- First posted
- 2018-10-02
- Last updated
- 2023-08-30
- Results first posted
- 2023-08-30
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Intraocular Pressure at Week 1 | 08:00, 10:00 and 16:00 at Week 1 | Intraocular Pressure (IOP), the fluid pressure inside the eye was measured with calibrated Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time points throughout the day. Analysis using Mixed-Effects Model for Repeated Measures (MMRM) |
| Primary | Intraocular Pressure at Week 6 | 08:00, 10:00 and 16:00 at Week 6 | Intraocular Pressure (IOP), the fluid pressure inside the eye was measured with calibrated Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time points throughout the day. Analysis using Mixed-Effects Model for Repeated Measures (MMRM) |
| Primary | Intraocular Pressure at Month 3 | 08:00, 10:00 and 16:00 at Month 3 | Intraocular Pressure (IOP), the fluid pressure inside the eye was measured with calibrated Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time points throughout the day. Analysis using Mixed-Effects Model for Repeated Measures (MMRM) |
| Secondary | Mean Diurnal Intraocular Pressure (IOP) at Month 3 (First Key Secondary Endpoint) | Month 3 | Mean Diurnal Intraocular Pressure (IOP) at Month 3: Analysis using Mixed-Effects Model for Repeated Measures (MMRM) on observed cases. |
| Secondary | Intraocular Pressure (IOP) at Week 1 With Baseline Mean Diurnal IOP Less Than 25 mmHg (Second Key Secondary Endpoint) | 08:00, 10:00 and 16:00 at Week 1 | Intraocular Pressure (IOP) at Week 1 with baseline mean diurnal IOP less than 25 mmHg (Second Key Secondary Endpoint) |
| Secondary | Intraocular Pressure (IOP) at Week 6 With Baseline Mean Diurnal IOP Less Than 25 mmHg (Second Key Secondary Endpoint) | 08:00, 10:00 and 16:00 at Week 6 | Intraocular Pressure (IOP) at Week 6 with baseline mean diurnal IOP less than 25 mmHg (Second Key Secondary Endpoint) |
| Secondary | Intraocular Pressure (IOP) at Month 3 With Baseline Mean Diurnal IOP Less Than 25 mmHg (Second Key Secondary Endpoint) | 08:00, 10:00 and 16:00 at Month 3 | Intraocular Pressure (IOP) at Month 3 with baseline mean diurnal IOP less than 25 mmHg (Second Key Secondary Endpoint) |
| Secondary | Mean Diurnal Intraocular Pressure (IOP) at Week 1 (Third Key Secondary Endpoint) | Week 1 | Mean Diurnal Intraocular Pressure (IOP) at Week 1: Analysis using Mixed-Effects Model for Repeated Measures (MMRM) on observed cases. Mean Diurnal IOP at week 1 is defined as the average IOP of all three timepoints (8AM, 10AM and 4PM) at week 1. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Intraocular Pressure at Week 1 | 08:00, 10:00 and 16:00 at Week 1 | Full Analysis Set (FAS) included all randomized subjects who received at least one dose of study medication and provided baseline and at least one post-baseline IOP measurement. The number of analyzed are participants evaluable for the outcome measure at Week 1. | mmHg | LEAST_SQUARES_MEAN |
| PRIMARY | Intraocular Pressure at Week 6 | 08:00, 10:00 and 16:00 at Week 6 | Full Analysis Set (FAS) included all randomized subjects who received at least one dose of study medication and provided baseline and at least one post-baseline IOP measurement. The number of analyzed are participants evaluable for the outcome measure at Week 6. | mmHg | LEAST_SQUARES_MEAN |
| PRIMARY | Intraocular Pressure at Month 3 | 08:00, 10:00 and 16:00 at Month 3 | Full Analysis Set (FAS) included all randomized subjects who received at least one dose of study medication and provided baseline and at least one post-baseline IOP measurement. The number of analyzed are participants evaluable for the outcome measure at Month 3. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Diurnal Intraocular Pressure (IOP) at Month 3 (First Key Secondary Endpoint) | Month 3 | Full Analysis Set (FAS) included all randomized subjects who received at least one dose of study medication and provided baseline and at least one post-baseline IOP measurement. The number of analyzed are participants evaluable for the outcome measure at Month 3. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Intraocular Pressure (IOP) at Week 1 With Baseline Mean Diurnal IOP Less Than 25 mmHg (Second Key Secondary Endpoint) | 08:00, 10:00 and 16:00 at Week 1 | Full Analysis Set (FAS) included all randomized subjects who received at least one dose of study medication and provided baseline and at least one post-baseline IOP measurement. The number of analyzed are participants evaluable for the outcome measure at Week 1. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Intraocular Pressure (IOP) at Week 6 With Baseline Mean Diurnal IOP Less Than 25 mmHg (Second Key Secondary Endpoint) | 08:00, 10:00 and 16:00 at Week 6 | Full Analysis Set (FAS) included all randomized subjects who received at least one dose of study medication and provided baseline and at least one post-baseline IOP measurement. The number of analyzed are participants evaluable for the outcome measure at Week 6. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Intraocular Pressure (IOP) at Month 3 With Baseline Mean Diurnal IOP Less Than 25 mmHg (Second Key Secondary Endpoint) | 08:00, 10:00 and 16:00 at Month 3 | Full Analysis Set (FAS) included all randomized subjects who received at least one dose of study medication and provided baseline and at least one post-baseline IOP measurement. The number of analyzed are participants evaluable for the outcome measure at Month 3. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Diurnal Intraocular Pressure (IOP) at Week 1 (Third Key Secondary Endpoint) | Week 1 | Full Analysis Set (FAS) included all randomized subjects who received at least one dose of study medication and provided baseline and at least one post-baseline IOP measurement. The number of analyzed are participants evaluable for the outcome measure at Week 1. | mmHg | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Intraocular Pressure at Week 1 | DE-117 Ophthalmic Solution | 8:00 | 19.0 | Standard Error 0.22 | mmHg |
| Intraocular Pressure at Week 1 | Timolol Maleate Ophthalmic Solution 0.5% | 8:00 | 19.1 | Standard Error 0.21 | mmHg |
| Intraocular Pressure at Week 1 | DE-117 Ophthalmic Solution | 10:00 | 18.0 | Standard Error 0.21 | mmHg |
| Intraocular Pressure at Week 1 | Timolol Maleate Ophthalmic Solution 0.5% | 10:00 | 18.2 | Standard Error 0.21 | mmHg |
| Intraocular Pressure at Week 1 | DE-117 Ophthalmic Solution | 16:00 | 17.5 | Standard Error 0.21 | mmHg |
| Intraocular Pressure at Week 1 | Timolol Maleate Ophthalmic Solution 0.5% | 16:00 | 17.9 | Standard Error 0.21 | mmHg |
| Intraocular Pressure at Week 6 | DE-117 Ophthalmic Solution | 8:00 | 19.8 | Standard Error 0.20 | mmHg |
| Intraocular Pressure at Week 6 | Timolol Maleate Ophthalmic Solution 0.5% | 8:00 | 18.4 | Standard Error 0.20 | mmHg |
| Intraocular Pressure at Week 6 | DE-117 Ophthalmic Solution | 10:00 | 18.9 | Standard Error 0.20 | mmHg |
| Intraocular Pressure at Week 6 | Timolol Maleate Ophthalmic Solution 0.5% | 10:00 | 18.0 | Standard Error 0.20 | mmHg |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double Masked Treatment Period (DMTP) | STARTED | DE-117 Ophthalmic Solution | 212 | |
| Double Masked Treatment Period (DMTP) | STARTED | Timolol Maleate Ophthalmic Solution 0.5% | 214 | |
| Double Masked Treatment Period (DMTP) | Full Analysis Set Participants | DE-117 Ophthalmic Solution | 212 | |
| Double Masked Treatment Period (DMTP) | Full Analysis Set Participants | Timolol Maleate Ophthalmic Solution 0.5% | 213 | |
| Double Masked Treatment Period (DMTP) | Safety Analysis Set Participants | DE-117 Ophthalmic Solution | 211 | |
| Double Masked Treatment Period (DMTP) | Safety Analysis Set Participants | Timolol Maleate Ophthalmic Solution 0.5% | 215 | |
| Double Masked Treatment Period (DMTP) | COMPLETED | DE-117 Ophthalmic Solution | 189 | |
| Double Masked Treatment Period (DMTP) | COMPLETED | Timolol Maleate Ophthalmic Solution 0.5% | 204 | |
| Double Masked Treatment Period (DMTP) | NOT COMPLETED | DE-117 Ophthalmic Solution | 23 | |
| Double Masked Treatment Period (DMTP) | NOT COMPLETED | Timolol Maleate Ophthalmic Solution 0.5% | 10 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events129
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 (Double Masked Treatment Period) | 13 | 211 | |
| other | Conjunctival hyperaemia | Eye disorders | Timolol Maleate Ophthalmic Solution 0.5% (Double Masked Treatment Period) | 10 | 215 | |
| other | Conjunctival hyperaemia | Eye disorders | DE-117 Ophthalmic Solution (Open Label Treatment Period) | 12 | 377 | |
| other | Vision blurred | Eye disorders | DE-117 Ophthalmic Solution (Double Masked Treatment Period) | 11 | 211 | |
| other | Vision blurred | Eye disorders | Timolol Maleate Ophthalmic Solution 0.5% (Double Masked Treatment Period) | 3 | 215 | |
| other | Vision blurred | Eye disorders | DE-117 Ophthalmic Solution (Open Label Treatment Period) | 14 | 377 | |
| other | Photophobia | Eye disorders | DE-117 Ophthalmic Solution (Double Masked Treatment Period) | 10 | 211 | |
| other | Photophobia | Eye disorders | Timolol Maleate Ophthalmic Solution 0.5% (Double Masked Treatment Period) | 1 | 215 | |
| other | Photophobia | Eye disorders | DE-117 Ophthalmic Solution (Open Label Treatment Period) | 4 | 377 | |
| other | Ocular hyperaemia | Eye disorders | DE-117 Ophthalmic Solution (Double Masked Treatment Period) | 6 | 211 |
1 to 10 of 129Source ClinicalTrials.gov
See all 129 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | DE-117 Ophthalmic Solution (Double Masked Treatment Period) | 0 | 211 |
| Total, all-cause mortality | Timolol Maleate Ophthalmic Solution 0.5% (Double Masked Treatment Period) | 1 | 215 |
| Total, all-cause mortality | DE-117 Ophthalmic Solution (Open Label Treatment Period) | 1 | 377 |
| Total, other adverse events | DE-117 Ophthalmic Solution (Double Masked Treatment Period) | 61 | 211 |
| Total, other adverse events | Timolol Maleate Ophthalmic Solution 0.5% (Double Masked Treatment Period) | 47 | 215 |
| Total, other adverse events | DE-117 Ophthalmic Solution (Open Label Treatment Period) | 85 | 377 |
| Total, serious adverse events | DE-117 Ophthalmic Solution (Double Masked Treatment Period) | 4 | 211 |
| Total, serious adverse events | Timolol Maleate Ophthalmic Solution 0.5% (Double Masked Treatment Period) | 5 | 215 |
| Total, serious adverse events | DE-117 Ophthalmic Solution (Open Label Treatment Period) | 12 | 377 |
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/NCT03691649
GET https://conductscience.org/api/trials/v1/NCT03691649/results?page=2