Trial Outcomes & Findings for DE-111 Against Tafluprost Ophthalmic Solution 0.0015% Alone and Concomitant Use of Tafluprost Ophthalmic Solution 0.0015% Plus Timolol Ophthalmic Solution 0.5% (NCT NCT01342081)
NCT ID: NCT01342081
Last Updated: 2015-06-15
Results Overview
Mean diurnal IOP(intraocular pressure) was calculated as an average of IOP(intraocular pressure) at 9:30 (pre-dose), 11:30 and 17:30.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
489 participants
Primary outcome timeframe
Week 0(Baseline) and Week 4(End of Study)
Results posted on
2015-06-15
Participant Flow
Switched to following three arms randomly from Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily).
Participant milestones
| Measure |
DE-111
DE-111 ophthalmic solution (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
|
Tafluprost
Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
|
Tafluprost Plus Timolol
Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily) and Timolol ophthalmic solution 0.5% (one drop at a time, BID) in both eyes.
|
|---|---|---|---|
|
Overall Study
STARTED
|
161
|
164
|
164
|
|
Overall Study
COMPLETED
|
159
|
162
|
163
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
1
|
Reasons for withdrawal
| Measure |
DE-111
DE-111 ophthalmic solution (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
|
Tafluprost
Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
|
Tafluprost Plus Timolol
Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily) and Timolol ophthalmic solution 0.5% (one drop at a time, BID) in both eyes.
|
|---|---|---|---|
|
Overall Study
Did not receive allocated intervention
|
0
|
0
|
1
|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
Baseline Characteristics
DE-111 Against Tafluprost Ophthalmic Solution 0.0015% Alone and Concomitant Use of Tafluprost Ophthalmic Solution 0.0015% Plus Timolol Ophthalmic Solution 0.5%
Baseline characteristics by cohort
| Measure |
DE-111
n=161 Participants
DE-111 ophthalmic solution (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
|
Tafluprost
n=163 Participants
Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
|
Tafluprost Plus Timolol
n=163 Participants
Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily) and Timolol ophthalmic solution 0.5% (one drop at a time, BID) in both eyes.
|
Total
n=487 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
92 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
260 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
69 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
227 Participants
n=4 Participants
|
|
Age, Continuous
|
61.6 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
63.0 years
STANDARD_DEVIATION 12.6 • n=7 Participants
|
60.6 years
STANDARD_DEVIATION 13.6 • n=5 Participants
|
61.7 years
STANDARD_DEVIATION 12.7 • n=4 Participants
|
|
Sex: Female, Male
Female
|
76 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
252 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
85 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
235 Participants
n=4 Participants
|
|
Region of Enrollment
Japan
|
161 participants
n=5 Participants
|
163 participants
n=7 Participants
|
163 participants
n=5 Participants
|
487 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Week 0(Baseline) and Week 4(End of Study)Mean diurnal IOP(intraocular pressure) was calculated as an average of IOP(intraocular pressure) at 9:30 (pre-dose), 11:30 and 17:30.
Outcome measures
| Measure |
DE-111
n=161 Participants
DE-111 ophthalmic solution (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
|
Tafluprost
n=163 Participants
Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
|
Tafluprost Plus Timolol
n=163 Participants
Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily) and Timolol ophthalmic solution 0.5% (one drop at a time, BID) in both eyes.
|
|---|---|---|---|
|
Change From Baseline in Mean Diurnal IOP(Intraocular Pressure) at End of Study
|
-2.6 mmHg
Standard Deviation 1.8
|
-0.9 mmHg
Standard Deviation 1.7
|
-2.2 mmHg
Standard Deviation 1.8
|
Adverse Events
DE-111
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Tafluprost
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Tafluprost Plus Timolol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
General Manager of Clinical Development Group
Santen Pharmaceutical Co., Ltd.
Phone: +81-6-4802-9341
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place