Trial · NCT04742283
Multicenter Study Assessing the Efficacy and Safety of DE-126 Ophthalmic Solution 0.002% Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension
NCT04742283, Phase 2, Completed, Santen Inc.; results first posted 2023-01-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Multicenter Study Assessing the Efficacy and Safety of DE-126 Ophthalmic Solution 0.002% Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension. Trials, record NCT04742283. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04742283
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Multicenter Study Assessing the Efficacy and Safety of DE-126 Ophthalmic Solution 0.002% Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension
- NCT number
- NCT04742283
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 323 participants, actual
- Lead sponsor
- Santen Inc.
- Conditions
- Primary Open Angle Glaucoma, Ocular Hypertension
- Interventions
- DE-126 Ophthalmic Solution 0.002% QD, Timolol Maleate Ophthalmic Solution 0.5% BID
- First posted
- 2021-02-08
- Last updated
- 2023-06-22
- Results first posted
- 2023-01-26
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Intraocular Pressure at Week 2 | 08:00, 10:00 and 16:00 at Week 2 | Intraocular pressure (IOP), the fluid pressure inside the eye was measure by the 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 measure by the 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 measure by the 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 at Month 3 | Three months | Mean diurnal Intraocular Pressure (IOP) was defined as the mean of the IOP valued at the three schedules timepoints (8:00, 10:00 and 16:00) at that visit for that subject. |
Source ClinicalTrials.gov
Outcomes4
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 2 | 08:00, 10:00 and 16:00 at Week 2 | The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of the study medication (test or control medication) and had at least one post-baseline efficacy assessment of the study eye during the study. | mmHg | LEAST_SQUARES_MEAN |
| PRIMARY | Intraocular Pressure at Week 6 | 08:00, 10:00 and 16:00 at Week 6 | The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of the study medication (test or control medication) and had at least one post-baseline efficacy assessment of the study eye during the study. | mmHg | LEAST_SQUARES_MEAN |
| PRIMARY | Intraocular Pressure at Month 3 | 08:00, 10:00 and 16:00 at Month 3 | The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of the study medication (test or control medication) and had at least one post-baseline efficacy assessment of the study eye during the study. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Diurnal Intraocular Pressure at Month 3 | Three months | The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of the study medication (test or control medication) and had at least one post-baseline efficacy assessment of the study eye during the study. | mmHg | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group20
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 2 | Timolol Maleate Opthalmic Solution 0.5% BID | 8:00 | 19.05 | Standard Error 0.242 | mmHg |
| Intraocular Pressure at Week 2 | DE-126 Opthalmic Solution 0.002% QD and Vehicle QD | 8:00 | 18.92 | Standard Error 0.239 | mmHg |
| Intraocular Pressure at Week 2 | Timolol Maleate Opthalmic Solution 0.5% BID | 10:00 | 18.28 | Standard Error 0.219 | mmHg |
| Intraocular Pressure at Week 2 | DE-126 Opthalmic Solution 0.002% QD and Vehicle QD | 10:00 | 17.86 | Standard Error 0.216 | mmHg |
| Intraocular Pressure at Week 2 | Timolol Maleate Opthalmic Solution 0.5% BID | 16:00 | 17.91 | Standard Error 0.215 | mmHg |
| Intraocular Pressure at Week 2 | DE-126 Opthalmic Solution 0.002% QD and Vehicle QD | 16:00 | 17.15 | Standard Error 0.212 | mmHg |
| Intraocular Pressure at Week 6 | Timolol Maleate Opthalmic Solution 0.5% BID | 8:00 | 18.72 | Standard Error 0.238 | mmHg |
| Intraocular Pressure at Week 6 | DE-126 Opthalmic Solution 0.002% QD and Vehicle QD | 8:00 | 18.32 | Standard Error 0.233 | mmHg |
| Intraocular Pressure at Week 6 | Timolol Maleate Opthalmic Solution 0.5% BID | 10:00 | 18.29 | Standard Error 0.238 | mmHg |
| Intraocular Pressure at Week 6 | DE-126 Opthalmic Solution 0.002% QD and Vehicle QD | 10:00 | 17.96 | Standard Error 0.233 | mmHg |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Timolol Maleate Opthalmic Solution 0.5% BID | 161 | |
| Overall Study | STARTED | DE-126 Opthalmic Solution 0.002% QD and Vehicle QD | 162 | |
| Overall Study | COMPLETED | Timolol Maleate Opthalmic Solution 0.5% BID | 148 | |
| Overall Study | COMPLETED | DE-126 Opthalmic Solution 0.002% QD and Vehicle QD | 158 | |
| Overall Study | NOT COMPLETED | Timolol Maleate Opthalmic Solution 0.5% BID | 13 | |
| Overall Study | NOT COMPLETED | DE-126 Opthalmic Solution 0.002% QD and Vehicle QD | 4 |
Source ClinicalTrials.gov
Adverse events104
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 | Timolol Maleate Opthalmic Solution 0.5% BID | 4 | 160 | |
| other | Conjunctival hyperaemia | Eye disorders | DE-126 Opthalmic Solution 0.002% QD and Vehicle QD | 16 | 161 | |
| other | Eye pruritus | Eye disorders | Timolol Maleate Opthalmic Solution 0.5% BID | 1 | 160 | |
| other | Eye pruritus | Eye disorders | DE-126 Opthalmic Solution 0.002% QD and Vehicle QD | 4 | 161 | |
| other | Eye pain | Eye disorders | Timolol Maleate Opthalmic Solution 0.5% BID | 1 | 160 | |
| other | Eye pain | Eye disorders | DE-126 Opthalmic Solution 0.002% QD and Vehicle QD | 3 | 161 | |
| other | Dry eye | Eye disorders | Timolol Maleate Opthalmic Solution 0.5% BID | 2 | 160 | |
| other | Dry eye | Eye disorders | DE-126 Opthalmic Solution 0.002% QD and Vehicle QD | 2 | 161 | |
| other | Foreign body sensation in eyes | Eye disorders | Timolol Maleate Opthalmic Solution 0.5% BID | 1 | 160 | |
| other | Foreign body sensation in eyes | Eye disorders | DE-126 Opthalmic Solution 0.002% QD and Vehicle QD | 2 | 161 |
1 to 10 of 104Source ClinicalTrials.gov
See all 104 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Timolol Maleate Opthalmic Solution 0.5% BID | 0 | 160 |
| Total, all-cause mortality | DE-126 Opthalmic Solution 0.002% QD and Vehicle QD | 0 | 161 |
| Total, other adverse events | Timolol Maleate Opthalmic Solution 0.5% BID | 34 | 160 |
| Total, other adverse events | DE-126 Opthalmic Solution 0.002% QD and Vehicle QD | 38 | 161 |
| Total, serious adverse events | Timolol Maleate Opthalmic Solution 0.5% BID | 3 | 160 |
| Total, serious adverse events | DE-126 Opthalmic Solution 0.002% QD and Vehicle QD | 1 | 161 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40043909 | 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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Timolol Maleate Opthalmic Solution 0.5% BID vs DE-126 Opthalmic Solution 0.002% QD and Vehicle QD: deaths from any cause | Trial comparisons |
| Timolol Maleate Opthalmic Solution 0.5% BID vs DE-126 Opthalmic Solution 0.002% QD and Vehicle QD: 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/NCT04742283
GET https://conductscience.org/api/trials/v1/NCT04742283/events?page=2