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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

A Randomized, Double-Masked, Parallel-Group, Multicenter Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution 0.002% Once Daily and Twice Daily in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension SPECTRUM 6 Study.

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03858894
Enrollment
98
Registered
2019-03-01
Start date
2019-01-28
Completion date
2019-06-20
Last updated
2020-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Open-angle Glaucoma and Ocular Hypertension

Brief summary

This is a randomized, double-masked, parallel-group, multi-center study. Subjects diagnosed with POAG or OHT who meet eligibility criteria at Visit 1 (Screening) will wash out their current topical IOP lowering medication(s), if any. After completing the required washout period, subjects will return for Visit 2 (Baseline, Day 1). Subjects who meet all eligibility criteria at Visit 2 (Baseline, Day 1) will be randomized to receive study medication for up to 6 weeks. Approximately 100 subjects with POAG or OHT will be randomized in a 1:1 ratio to either: * DE-117 ophthalmic solution 0.002% QD (Once Daily) * DE-117 ophthalmic solution 0.002% BID (Twice Daily) This study will consist of a screening period of up to 35 days including a washout period of up to 28 days (+ 7 days window), and a 6-week double-masked treatment period.

Interventions

DRUGDE-117 Ophthalmic Solution QD

DE-117 ophthalmic solution QD and Vehicle (no active DE-117 ingredient) QD add one drop in each eye

DRUGDE-117 Ophthalmic Solution BID

DE-117 ophthalmic solution BID twice Daily (20:00 and 8:00) add one drop in each eye

Sponsors

Santen Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Provide signed written informed consent * Have a diagnosis of POAG or OHT in both eyes, or one eye with POAG and the other with OHT. * Qualifying corrected visual acuity in each eye * Qualifying central corneal thickness in each eye * Qualifying Day 1 IOP measurement at 3 time-points in both eyes * Qualifying Anterior chamber angle

Exclusion criteria

* History of ocular surgery specifically intended to lower IOP * Subjects who cannot safely discontinue use of ocular hypotensive medications during the wait/washout period * Advanced glaucoma in either eye * Any corneal abnormality or other condition interfering with or preventing reliable Goldmann applanation tonometry * Any ocular surgery or ocular laser treatment within 180 days prior to Screening and throughout the study in either eye * Females who are pregnant, nursing, or planning a pregnancy

Design outcomes

Primary

MeasureTime frameDescription
Intraocular Pressure (IOP) at Week 608:00 at week 6Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).
Intraocular Pressure (IOP) at Week 208:00 at week 2Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).

Secondary

MeasureTime frameDescription
Mean Diurnal Intraocular Pressure (IOP)6 weeksIntraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).

Countries

United States

Participant flow

Participants by arm

ArmCount
Test Arm: DE-117 BID
DE-117 Ophthalmic Solution BID Twice daily (20:00 and 8:00) DE-117 Ophthalmic Solution BID: DE-117 ophthalmic solution BID twice Daily (20:00 and 8:00) add one drop in each eye
48
Drug Arm: DE-117 QD
DE-117 Ophthalmic Solution QD (20:00) and Vehicle (8:00; no active DE-117 ingredient) QD DE-117 Ophthalmic Solution QD: DE-117 ophthalmic solution QD and Vehicle (no active DE-117 ingredient) QD add one drop in each eye
50
Total98

Baseline characteristics

CharacteristicDrug Arm: DE-117 QDTotalTest Arm: DE-117 BID
Age, Continuous66.3 years
STANDARD_DEVIATION 8.73
66.8 years
STANDARD_DEVIATION 9.05
67.3 years
STANDARD_DEVIATION 9.45
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants4 Participants2 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
48 Participants94 Participants46 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
14 Participants27 Participants13 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants1 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
35 Participants70 Participants35 Participants
Sex: Female, Male
Female
25 Participants52 Participants27 Participants
Sex: Female, Male
Male
25 Participants46 Participants21 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 480 / 50
other
Total, other adverse events
20 / 487 / 50
serious
Total, serious adverse events
0 / 481 / 50

Outcome results

Primary

Intraocular Pressure (IOP) at Week 2

Intraocular pressure (IOP), the fluid pressure inside the eye, was mea...

Time frame: 16:00 at week 2

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Test Arm: DE-117 BIDIntraocular Pressure (IOP) at Week 216.73 mmHgStandard Error 0.47
Drug Arm: DE-117 QDIntraocular Pressure (IOP) at Week 217.81 mmHgStandard Error 0.44
Primary

Intraocular Pressure (IOP) at Week 2

Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).

Time frame: 08:00 at week 2

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Test Arm: DE-117 BIDIntraocular Pressure (IOP) at Week 218.19 mmHgStandard Error 0.46
Drug Arm: DE-117 QDIntraocular Pressure (IOP) at Week 219.15 mmHgStandard Error 0.45
Primary

Intraocular Pressure (IOP) at Week 2

Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).

Time frame: 12:00 at week 2

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Test Arm: DE-117 BIDIntraocular Pressure (IOP) at Week 217.73 mmHgStandard Error 0.49
Drug Arm: DE-117 QDIntraocular Pressure (IOP) at Week 218.17 mmHgStandard Error 0.46
Primary

Intraocular Pressure (IOP) at Week 6

Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).

Time frame: 08:00 at week 6

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Test Arm: DE-117 BIDIntraocular Pressure (IOP) at Week 618.33 mmHgStandard Error 0.49
Drug Arm: DE-117 QDIntraocular Pressure (IOP) at Week 619.01 mmHgStandard Error 0.47
Primary

Intraocular Pressure (IOP) at Week 6

Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).

Time frame: 12:00 at week 6

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Test Arm: DE-117 BIDIntraocular Pressure (IOP) at Week 617.77 mmHgStandard Error 0.45
Drug Arm: DE-117 QDIntraocular Pressure (IOP) at Week 618.35 mmHgStandard Error 0.43
Primary

Intraocular Pressure (IOP) at Week 6

Intraocular pressure (IOP), the fluid pressure inside the eye, was mea...

Time frame: 16:00 at week 6

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Test Arm: DE-117 BIDIntraocular Pressure (IOP) at Week 617.30 mmHgStandard Error 0.45
Drug Arm: DE-117 QDIntraocular Pressure (IOP) at Week 617.66 mmHgStandard Error 0.43
Secondary

Mean Diurnal Intraocular Pressure (IOP)

Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).

Time frame: 6 weeks

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Test Arm: DE-117 BIDMean Diurnal Intraocular Pressure (IOP)17.77 mmHgStandard Error 0.43
Drug Arm: DE-117 QDMean Diurnal Intraocular Pressure (IOP)18.37 mmHgStandard Error 0.41

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026