Trial · NCT03691662
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 4 Study
NCT03691662, Phase 3, Completed, Santen Inc.; results first posted 2023-08-09
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 4 Study. Trials, record NCT03691662. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03691662
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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 4 Study
- NCT number
- NCT03691662
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 417 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
- 2023-08-09
- Results first posted
- 2023-08-09
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 (IOP) at Week 1 | 08:00, 10:00 and 16:00 at Week 1 | Intraocular Pressure: Analysis of IOP Score using Mixed Model for Repeated Measures (MMRM) on Observed Cases (Study Eye, Full Analysis Set). 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. |
| Primary | Intraocular Pressure (IOP) at Week 6 | 08:00, 10:00 and 16:00 at Week 6 | Intraocular Pressure: Analysis of IOP Score using Mixed Model for Repeated Measures (MMRM) on Observed Cases (Study Eye, Full Analysis Set). 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. |
| Primary | Intraocular Pressure (IOP) at Month 3 | 08:00, 10:00 and 16:00 at Month 3 | Intraocular Pressure: Analysis of IOP Score using Mixed Model for Repeated Measures (MMRM) on Observed Cases (Study Eye, Full Analysis Set). 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. |
| Secondary | Mean Diurnal Intraocular Pressure (IOP) at Month 3 (First Key Secondary Endpoint) | Month 3 | To determine if the mean diurnal IOP reduction with DE-117 ophthalmic solution 0.002% is superior to that of Timolol Maleate ophthalmic solution 0.5% at Month 3 in subjects with OAG or OHT. Mean Diurnal IOP is defined as the average IOP of all three timepoints (8AM, 10AM and 4PM) at Month 3. |
| 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 | The third key secondary endpoint, mean diurnal IOP at Week 1, the hypothesis of superiority of DE-117 to timolol was tested. Analysis using MMRM on Observed Cases. Mean Diurnal IOP 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 (IOP) 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 (IOP) 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 (IOP) 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 (IOP) at Week 1 | DE-117 Ophthalmic Solution 0.002% QD (20:00) and Vehicle QD (08:00) | 8:00 | 19.4 | Standard Error 0.23 | mmHg |
| Intraocular Pressure (IOP) at Week 1 | Timolol Maleate Ophthalmic Solution 0.5% BID (20:00 & 08:00) | 8:00 | 19.7 | Standard Error 0.23 | mmHg |
| Intraocular Pressure (IOP) at Week 1 | DE-117 Ophthalmic Solution 0.002% QD (20:00) and Vehicle QD (08:00) | 10:00 | 18.5 | Standard Error 0.22 | mmHg |
| Intraocular Pressure (IOP) at Week 1 | Timolol Maleate Ophthalmic Solution 0.5% BID (20:00 & 08:00) | 10:00 | 18.9 | Standard Error 0.22 | mmHg |
| Intraocular Pressure (IOP) at Week 1 | DE-117 Ophthalmic Solution 0.002% QD (20:00) and Vehicle QD (08:00) | 16:00 | 17.9 | Standard Error 0.23 | mmHg |
| Intraocular Pressure (IOP) at Week 1 | Timolol Maleate Ophthalmic Solution 0.5% BID (20:00 & 08:00) | 16:00 | 18.6 | Standard Error 0.22 | mmHg |
| Intraocular Pressure (IOP) at Week 6 | DE-117 Ophthalmic Solution 0.002% QD (20:00) and Vehicle QD (08:00) | 8:00 | 20.4 | Standard Error 0.22 | mmHg |
| Intraocular Pressure (IOP) at Week 6 | Timolol Maleate Ophthalmic Solution 0.5% BID (20:00 & 08:00) | 8:00 | 19.5 | Standard Error 0.21 | mmHg |
| Intraocular Pressure (IOP) at Week 6 | DE-117 Ophthalmic Solution 0.002% QD (20:00) and Vehicle QD (08:00) | 10:00 | 19.5 | Standard Error 0.20 | mmHg |
| Intraocular Pressure (IOP) at Week 6 | Timolol Maleate Ophthalmic Solution 0.5% BID (20:00 & 08:00) | 10:00 | 18.8 | Standard Error 0.20 | mmHg |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow8
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% QD (20:00) and Vehicle QD (08:00) | 208 | |
| Overall Study | STARTED | Timolol Maleate Ophthalmic Solution 0.5% BID (20:00 & 08:00) | 209 | |
| Overall Study | Safety and Full Analysis Set (FAS) Participants | DE-117 Ophthalmic Solution 0.002% QD (20:00) and Vehicle QD (08:00) | 204 | |
| Overall Study | Safety and Full Analysis Set (FAS) Participants | Timolol Maleate Ophthalmic Solution 0.5% BID (20:00 & 08:00) | 205 | |
| Overall Study | COMPLETED | DE-117 Ophthalmic Solution 0.002% QD (20:00) and Vehicle QD (08:00) | 187 | |
| Overall Study | COMPLETED | Timolol Maleate Ophthalmic Solution 0.5% BID (20:00 & 08:00) | 196 | |
| Overall Study | NOT COMPLETED | DE-117 Ophthalmic Solution 0.002% QD (20:00) and Vehicle QD (08:00) | 21 | |
| Overall Study | NOT COMPLETED | Timolol Maleate Ophthalmic Solution 0.5% BID (20:00 & 08:00) | 13 |
Source ClinicalTrials.gov
Adverse events76
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 | 16 | 204 | |
| other | Conjunctival hyperaemia | Eye disorders | Timolol Maleate Ophthalmic Solution 0.5% | 7 | 205 | |
| other | Photophobia | Eye disorders | DE-117 Ophthalmic Solution | 12 | 204 | |
| other | Photophobia | Eye disorders | Timolol Maleate Ophthalmic Solution 0.5% | 1 | 205 | |
| other | Vision blurred | Eye disorders | DE-117 Ophthalmic Solution | 6 | 204 | |
| other | Vision blurred | Eye disorders | Timolol Maleate Ophthalmic Solution 0.5% | 2 | 205 | |
| other | Ocular hyperaemia | Eye disorders | DE-117 Ophthalmic Solution | 4 | 204 | |
| other | Ocular hyperaemia | Eye disorders | Timolol Maleate Ophthalmic Solution 0.5% | 2 | 205 | |
| other | Anterior chamber cell | Eye disorders | DE-117 Ophthalmic Solution | 3 | 204 | |
| other | Anterior chamber cell | Eye disorders | Timolol Maleate Ophthalmic Solution 0.5% | 0 | 205 |
1 to 10 of 76Source ClinicalTrials.gov
See all 76 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 | 1 | 204 |
| Total, all-cause mortality | Timolol Maleate Ophthalmic Solution 0.5% | 0 | 205 |
| Total, other adverse events | DE-117 Ophthalmic Solution | 68 | 204 |
| Total, other adverse events | Timolol Maleate Ophthalmic Solution 0.5% | 49 | 205 |
| Total, serious adverse events | DE-117 Ophthalmic Solution | 7 | 204 |
| Total, serious adverse events | Timolol Maleate Ophthalmic Solution 0.5% | 1 | 205 |
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 Timolol Maleate Ophthalmic Solution 0.5%: deaths from any cause | Trial comparisons |
| DE-117 Ophthalmic Solution vs Timolol Maleate Ophthalmic Solution 0.5%: 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.
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