Trial · NCT03858894

Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution Once Daily and Twice Daily in Subjects With Primary Open-Angle Glaucoma SPECTRUM 6

NCT03858894, Phase 2, Completed, Santen Inc.; results first posted 2020-08-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution Once Daily and Twice Daily in Subjects With Primary Open-Angle Glaucoma SPECTRUM 6. Trials, record NCT03858894. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03858894

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution Once Daily and Twice Daily in Subjects With Primary Open-Angle Glaucoma SPECTRUM 6
NCT number: NCT03858894
Status: Completed
Phases: Phase 2
Enrollment: 98 participants, actual
Lead sponsor: Santen Inc.
Conditions: Primary Open-angle Glaucoma and Ocular Hypertension
Interventions: DE-117 Ophthalmic Solution QD, DE-117 Ophthalmic Solution BID
First posted: 2019-03-01
Last updated: 2020-08-04
Results first posted: 2020-08-04

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Intraocular Pressure (IOP) at Week 2	08:00 at week 2	Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).
Primary	Intraocular Pressure (IOP) at Week 2	12:00 at week 2	Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).
Primary	Intraocular Pressure (IOP) at Week 2	16:00 at week 2	Intraocular pressure (IOP), the fluid pressure inside the eye, was mea...
Primary	Intraocular Pressure (IOP) at Week 6	08:00 at week 6	Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).
Primary	Intraocular Pressure (IOP) at Week 6	12:00 at week 6	Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).
Primary	Intraocular Pressure (IOP) at Week 6	16:00 at week 6	Intraocular pressure (IOP), the fluid pressure inside the eye, was mea...
Secondary	Mean Diurnal Intraocular Pressure (IOP)	6 weeks	Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Intraocular Pressure (IOP) at Week 2	08:00 at week 2	mmHg	LEAST_SQUARES_MEAN
PRIMARY	Intraocular Pressure (IOP) at Week 2	12:00 at week 2	mmHg	LEAST_SQUARES_MEAN
PRIMARY	Intraocular Pressure (IOP) at Week 2	16:00 at week 2	mmHg	LEAST_SQUARES_MEAN
PRIMARY	Intraocular Pressure (IOP) at Week 6	08:00 at week 6	mmHg	LEAST_SQUARES_MEAN
PRIMARY	Intraocular Pressure (IOP) at Week 6	12:00 at week 6	mmHg	LEAST_SQUARES_MEAN
PRIMARY	Intraocular Pressure (IOP) at Week 6	16:00 at week 6	mmHg	LEAST_SQUARES_MEAN
SECONDARY	Mean Diurnal Intraocular Pressure (IOP)	6 weeks	mmHg	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group14

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Intraocular Pressure (IOP) at Week 2	Test Arm: DE-117 BID	18.19	Standard Error 0.46	mmHg
Intraocular Pressure (IOP) at Week 2	Drug Arm: DE-117 QD	19.15	Standard Error 0.45	mmHg
Intraocular Pressure (IOP) at Week 2	Test Arm: DE-117 BID	17.73	Standard Error 0.49	mmHg
Intraocular Pressure (IOP) at Week 2	Drug Arm: DE-117 QD	18.17	Standard Error 0.46	mmHg
Intraocular Pressure (IOP) at Week 2	Test Arm: DE-117 BID	16.73	Standard Error 0.47	mmHg
Intraocular Pressure (IOP) at Week 2	Drug Arm: DE-117 QD	17.81	Standard Error 0.44	mmHg
Intraocular Pressure (IOP) at Week 6	Test Arm: DE-117 BID	18.33	Standard Error 0.49	mmHg
Intraocular Pressure (IOP) at Week 6	Drug Arm: DE-117 QD	19.01	Standard Error 0.47	mmHg
Intraocular Pressure (IOP) at Week 6	Test Arm: DE-117 BID	17.77	Standard Error 0.45	mmHg
Intraocular Pressure (IOP) at Week 6	Drug Arm: DE-117 QD	18.35	Standard Error 0.43	mmHg

1 to 10 of 14Source ClinicalTrials.gov

See all 14 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Test Arm: DE-117 BID	48
Overall Study	STARTED	Drug Arm: DE-117 QD	50
Overall Study	COMPLETED	Test Arm: DE-117 BID	44
Overall Study	COMPLETED	Drug Arm: DE-117 QD	50
Overall Study	NOT COMPLETED	Test Arm: DE-117 BID	4
Overall Study	NOT COMPLETED	Drug Arm: DE-117 QD	0

Source ClinicalTrials.gov

Adverse events46

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	Test Arm: DE-117 BID	6	48	7
other	Conjunctival hyperaemia	Eye disorders	Drug Arm: DE-117 QD	0	50	0
other	Ocular hyperaemia	Eye disorders	Test Arm: DE-117 BID	5	48	5
other	Ocular hyperaemia	Eye disorders	Drug Arm: DE-117 QD	1	50	1
other	Accommodation disorder	Eye disorders	Test Arm: DE-117 BID	1	48	1
other	Accommodation disorder	Eye disorders	Drug Arm: DE-117 QD	0	50	0
other	Corneal pigmentation	Eye disorders	Test Arm: DE-117 BID	1	48	1
other	Corneal pigmentation	Eye disorders	Drug Arm: DE-117 QD	0	50	0
other	Eye pain	Eye disorders	Test Arm: DE-117 BID	1	48	1
other	Eye pain	Eye disorders	Drug Arm: DE-117 QD	1	50	1

1 to 10 of 46Source ClinicalTrials.gov

See all 46 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Test Arm: DE-117 BID	0	48
Total, all-cause mortality	Drug Arm: DE-117 QD	0	50
Total, other adverse events	Test Arm: DE-117 BID	20	48
Total, other adverse events	Drug Arm: DE-117 QD	7	50
Total, serious adverse events	Test Arm: DE-117 BID	0	48
Total, serious adverse events	Drug Arm: DE-117 QD	1	50

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
Test Arm: DE-117 BID vs Drug Arm: DE-117 QD: deaths from any cause	Trial comparisons
Test Arm: DE-117 BID vs Drug Arm: DE-117 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT03858894

GET https://conductscience.org/api/trials/v1/NCT03858894/events?page=2

API reference For AI assistants