Trial Outcomes & Findings for 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 NCT03858894)
NCT ID: NCT03858894
Last Updated: 2020-08-04
Results Overview
Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
98 participants
Primary outcome timeframe
08:00 at week 2
Results posted on
2020-08-04
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
48
|
50
|
|
Overall Study
COMPLETED
|
44
|
50
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
Test Arm: DE-117 BID
n=48 Participants
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
|
Drug Arm: DE-117 QD
n=50 Participants
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
|
Total
n=98 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.3 years
STANDARD_DEVIATION 9.45 • n=5 Participants
|
66.3 years
STANDARD_DEVIATION 8.73 • n=7 Participants
|
66.8 years
STANDARD_DEVIATION 9.05 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
46 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 08:00 at week 2Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).
Outcome measures
| Measure |
Test Arm: DE-117 BID
n=48 Participants
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
|
Drug Arm: DE-117 QD
n=50 Participants
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
|
|---|---|---|
|
Intraocular Pressure (IOP) at Week 2
|
18.19 mmHg
Standard Error 0.46
|
19.15 mmHg
Standard Error 0.45
|
PRIMARY outcome
Timeframe: 12:00 at week 2Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).
Outcome measures
| Measure |
Test Arm: DE-117 BID
n=48 Participants
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
|
Drug Arm: DE-117 QD
n=50 Participants
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
|
|---|---|---|
|
Intraocular Pressure (IOP) at Week 2
|
17.73 mmHg
Standard Error 0.49
|
18.17 mmHg
Standard Error 0.46
|
PRIMARY outcome
Timeframe: 16:00 at week 2Intraocular pressure (IOP), the fluid pressure inside the eye, was mea...
Outcome measures
| Measure |
Test Arm: DE-117 BID
n=48 Participants
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
|
Drug Arm: DE-117 QD
n=50 Participants
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
|
|---|---|---|
|
Intraocular Pressure (IOP) at Week 2
|
16.73 mmHg
Standard Error 0.47
|
17.81 mmHg
Standard Error 0.44
|
PRIMARY outcome
Timeframe: 08:00 at week 6Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).
Outcome measures
| Measure |
Test Arm: DE-117 BID
n=48 Participants
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
|
Drug Arm: DE-117 QD
n=50 Participants
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
|
|---|---|---|
|
Intraocular Pressure (IOP) at Week 6
|
18.33 mmHg
Standard Error 0.49
|
19.01 mmHg
Standard Error 0.47
|
PRIMARY outcome
Timeframe: 12:00 at week 6Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).
Outcome measures
| Measure |
Test Arm: DE-117 BID
n=48 Participants
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
|
Drug Arm: DE-117 QD
n=50 Participants
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
|
|---|---|---|
|
Intraocular Pressure (IOP) at Week 6
|
17.77 mmHg
Standard Error 0.45
|
18.35 mmHg
Standard Error 0.43
|
PRIMARY outcome
Timeframe: 16:00 at week 6Intraocular pressure (IOP), the fluid pressure inside the eye, was mea...
Outcome measures
| Measure |
Test Arm: DE-117 BID
n=48 Participants
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
|
Drug Arm: DE-117 QD
n=50 Participants
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
|
|---|---|---|
|
Intraocular Pressure (IOP) at Week 6
|
17.30 mmHg
Standard Error 0.45
|
17.66 mmHg
Standard Error 0.43
|
SECONDARY outcome
Timeframe: 6 weeksIntraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).
Outcome measures
| Measure |
Test Arm: DE-117 BID
n=48 Participants
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
|
Drug Arm: DE-117 QD
n=50 Participants
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
|
|---|---|---|
|
Mean Diurnal Intraocular Pressure (IOP)
|
17.77 mmHg
Standard Error 0.43
|
18.37 mmHg
Standard Error 0.41
|
Adverse Events
Test Arm: DE-117 BID
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Drug Arm: DE-117 QD
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Test Arm: DE-117 BID
n=48 participants at risk
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
|
Drug Arm: DE-117 QD
n=50 participants at risk
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
|
|---|---|---|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/48 • All SAEs were collected from the signing of the Inform Consent Form until the subject withdrew or completed the scheduled exit visit at Week 6.
|
2.0%
1/50 • Number of events 1 • All SAEs were collected from the signing of the Inform Consent Form until the subject withdrew or completed the scheduled exit visit at Week 6.
|
Other adverse events
| Measure |
Test Arm: DE-117 BID
n=48 participants at risk
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
|
Drug Arm: DE-117 QD
n=50 participants at risk
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
|
|---|---|---|
|
Eye disorders
Conjunctival hyperaemia
|
12.5%
6/48 • Number of events 7 • All SAEs were collected from the signing of the Inform Consent Form until the subject withdrew or completed the scheduled exit visit at Week 6.
|
0.00%
0/50 • All SAEs were collected from the signing of the Inform Consent Form until the subject withdrew or completed the scheduled exit visit at Week 6.
|
|
Eye disorders
Ocular hyperaemia
|
10.4%
5/48 • Number of events 5 • All SAEs were collected from the signing of the Inform Consent Form until the subject withdrew or completed the scheduled exit visit at Week 6.
|
2.0%
1/50 • Number of events 1 • All SAEs were collected from the signing of the Inform Consent Form until the subject withdrew or completed the scheduled exit visit at Week 6.
|
|
Eye disorders
Accommodation disorder
|
2.1%
1/48 • Number of events 1 • All SAEs were collected from the signing of the Inform Consent Form until the subject withdrew or completed the scheduled exit visit at Week 6.
|
0.00%
0/50 • All SAEs were collected from the signing of the Inform Consent Form until the subject withdrew or completed the scheduled exit visit at Week 6.
|
|
Eye disorders
Corneal pigmentation
|
2.1%
1/48 • Number of events 1 • All SAEs were collected from the signing of the Inform Consent Form until the subject withdrew or completed the scheduled exit visit at Week 6.
|
0.00%
0/50 • All SAEs were collected from the signing of the Inform Consent Form until the subject withdrew or completed the scheduled exit visit at Week 6.
|
|
Eye disorders
Eye pain
|
2.1%
1/48 • Number of events 1 • All SAEs were collected from the signing of the Inform Consent Form until the subject withdrew or completed the scheduled exit visit at Week 6.
|
2.0%
1/50 • Number of events 1 • All SAEs were collected from the signing of the Inform Consent Form until the subject withdrew or completed the scheduled exit visit at Week 6.
|
|
Eye disorders
Eye pruritus
|
2.1%
1/48 • Number of events 1 • All SAEs were collected from the signing of the Inform Consent Form until the subject withdrew or completed the scheduled exit visit at Week 6.
|
0.00%
0/50 • All SAEs were collected from the signing of the Inform Consent Form until the subject withdrew or completed the scheduled exit visit at Week 6.
|
|
Eye disorders
Glare
|
2.1%
1/48 • Number of events 1 • All SAEs were collected from the signing of the Inform Consent Form until the subject withdrew or completed the scheduled exit visit at Week 6.
|
0.00%
0/50 • All SAEs were collected from the signing of the Inform Consent Form until the subject withdrew or completed the scheduled exit visit at Week 6.
|
|
Eye disorders
Iridocyclitis
|
2.1%
1/48 • Number of events 1 • All SAEs were collected from the signing of the Inform Consent Form until the subject withdrew or completed the scheduled exit visit at Week 6.
|
0.00%
0/50 • All SAEs were collected from the signing of the Inform Consent Form until the subject withdrew or completed the scheduled exit visit at Week 6.
|
|
Eye disorders
Iritis
|
2.1%
1/48 • Number of events 1 • All SAEs were collected from the signing of the Inform Consent Form until the subject withdrew or completed the scheduled exit visit at Week 6.
|
0.00%
0/50 • All SAEs were collected from the signing of the Inform Consent Form until the subject withdrew or completed the scheduled exit visit at Week 6.
|
|
Eye disorders
Ocular discomfort
|
2.1%
1/48 • Number of events 1 • All SAEs were collected from the signing of the Inform Consent Form until the subject withdrew or completed the scheduled exit visit at Week 6.
|
0.00%
0/50 • All SAEs were collected from the signing of the Inform Consent Form until the subject withdrew or completed the scheduled exit visit at Week 6.
|
|
Eye disorders
Photophobia
|
2.1%
1/48 • Number of events 1 • All SAEs were collected from the signing of the Inform Consent Form until the subject withdrew or completed the scheduled exit visit at Week 6.
|
4.0%
2/50 • Number of events 2 • All SAEs were collected from the signing of the Inform Consent Form until the subject withdrew or completed the scheduled exit visit at Week 6.
|
|
Eye disorders
Vision blurred
|
2.1%
1/48 • Number of events 1 • All SAEs were collected from the signing of the Inform Consent Form until the subject withdrew or completed the scheduled exit visit at Week 6.
|
0.00%
0/50 • All SAEs were collected from the signing of the Inform Consent Form until the subject withdrew or completed the scheduled exit visit at Week 6.
|
|
Eye disorders
Visual impairment
|
2.1%
1/48 • Number of events 1 • All SAEs were collected from the signing of the Inform Consent Form until the subject withdrew or completed the scheduled exit visit at Week 6.
|
2.0%
1/50 • Number of events 1 • All SAEs were collected from the signing of the Inform Consent Form until the subject withdrew or completed the scheduled exit visit at Week 6.
|
|
Eye disorders
Punctate keratitis
|
0.00%
0/48 • All SAEs were collected from the signing of the Inform Consent Form until the subject withdrew or completed the scheduled exit visit at Week 6.
|
2.0%
1/50 • Number of events 1 • All SAEs were collected from the signing of the Inform Consent Form until the subject withdrew or completed the scheduled exit visit at Week 6.
|
|
Investigations
Vital dye staining cornea present
|
4.2%
2/48 • Number of events 3 • All SAEs were collected from the signing of the Inform Consent Form until the subject withdrew or completed the scheduled exit visit at Week 6.
|
2.0%
1/50 • Number of events 2 • All SAEs were collected from the signing of the Inform Consent Form until the subject withdrew or completed the scheduled exit visit at Week 6.
|
|
Gastrointestinal disorders
Nausea
|
2.1%
1/48 • Number of events 1 • All SAEs were collected from the signing of the Inform Consent Form until the subject withdrew or completed the scheduled exit visit at Week 6.
|
0.00%
0/50 • All SAEs were collected from the signing of the Inform Consent Form until the subject withdrew or completed the scheduled exit visit at Week 6.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.1%
1/48 • Number of events 1 • All SAEs were collected from the signing of the Inform Consent Form until the subject withdrew or completed the scheduled exit visit at Week 6.
|
0.00%
0/50 • All SAEs were collected from the signing of the Inform Consent Form until the subject withdrew or completed the scheduled exit visit at Week 6.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
2.1%
1/48 • Number of events 1 • All SAEs were collected from the signing of the Inform Consent Form until the subject withdrew or completed the scheduled exit visit at Week 6.
|
0.00%
0/50 • All SAEs were collected from the signing of the Inform Consent Form until the subject withdrew or completed the scheduled exit visit at Week 6.
|
|
Nervous system disorders
Headache
|
2.1%
1/48 • Number of events 1 • All SAEs were collected from the signing of the Inform Consent Form until the subject withdrew or completed the scheduled exit visit at Week 6.
|
4.0%
2/50 • Number of events 2 • All SAEs were collected from the signing of the Inform Consent Form until the subject withdrew or completed the scheduled exit visit at Week 6.
|
|
Product Issues
Device dislocation
|
2.1%
1/48 • Number of events 1 • All SAEs were collected from the signing of the Inform Consent Form until the subject withdrew or completed the scheduled exit visit at Week 6.
|
0.00%
0/50 • All SAEs were collected from the signing of the Inform Consent Form until the subject withdrew or completed the scheduled exit visit at Week 6.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/48 • All SAEs were collected from the signing of the Inform Consent Form until the subject withdrew or completed the scheduled exit visit at Week 6.
|
2.0%
1/50 • Number of events 1 • All SAEs were collected from the signing of the Inform Consent Form until the subject withdrew or completed the scheduled exit visit at Week 6.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/48 • All SAEs were collected from the signing of the Inform Consent Form until the subject withdrew or completed the scheduled exit visit at Week 6.
|
2.0%
1/50 • Number of events 1 • All SAEs were collected from the signing of the Inform Consent Form until the subject withdrew or completed the scheduled exit visit at Week 6.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Site/Investigator is not permitted to publish results communications without Santen's consent until after a period of sixty (60 days) for Santen review/comment. Santen may request removal of any Confidential Information (other than Study results) from manuscripts or materials prior to submission or presentation. At Santen's request Site/Investigator has to withhold any publication if there is a patentable invention until such time as Santen is able to secure adequate patent protection.
- Publication restrictions are in place
Restriction type: OTHER