Trial Outcomes & Findings for DE-111 Against Timolol Ophthalmic Solution 0.5% (NCT NCT01342094)
NCT ID: NCT01342094
Last Updated: 2015-07-10
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
166 participants
Primary outcome timeframe
Week 0(Baseline) and Week 4(End of Study)
Results posted on
2015-07-10
Participant Flow
Prior to randomization all participants in the study were receiving Timolol ophthalmic solution 0.5% (one drop at a time, BID).
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.
|
Timolol
Timolol ophthalmic solution 0.5% (one drop at a time, BID) and Placebo ophthalmic solution (one drop at a time, once daily) in both eyes.
|
|---|---|---|
|
Overall Study
STARTED
|
82
|
84
|
|
Overall Study
COMPLETED
|
77
|
81
|
|
Overall Study
NOT COMPLETED
|
5
|
3
|
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.
|
Timolol
Timolol ophthalmic solution 0.5% (one drop at a time, BID) and Placebo ophthalmic solution (one drop at a time, once daily) in both eyes.
|
|---|---|---|
|
Overall Study
Adverse Event
|
5
|
0
|
|
Overall Study
Not meeting inclusion/exclusion criteria
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
DE-111 Against Timolol Ophthalmic Solution 0.5%
Baseline characteristics by cohort
| Measure |
DE-111
n=82 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.
|
Timolol
n=84 Participants
Timolol ophthalmic solution 0.5% (one drop at a time, BID) and Placebo ophthalmic solution (one drop at a time, once daily) in both eyes.
|
Total
n=166 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
82 participants
n=5 Participants
|
84 participants
n=7 Participants
|
166 participants
n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
46 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
36 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Age, Continuous
|
61.6 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
63.1 years
STANDARD_DEVIATION 12.4 • n=7 Participants
|
62.4 years
STANDARD_DEVIATION 11.9 • n=5 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=82 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.
|
Timolol
n=84 Participants
Timolol ophthalmic solution 0.5% (one drop at a time, BID) and Placebo ophthalmic solution (one drop at a time, once daily) in both eyes.
|
|---|---|---|
|
Change From Baseline in Mean Diurnal IOP (Intraocular Pressure) at End of Study
|
-3.2 mmHg
Standard Deviation 2.1
|
-1.7 mmHg
Standard Deviation 2.1
|
Adverse Events
DE-111
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Timolol
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
DE-111
n=82 participants at risk
DE-111 ophthalmic solution (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
|
Timolol
n=84 participants at risk
Timolol ophthalmic solution 0.5% (one drop at a time, BID) and Placebo ophthalmic solution (one drop at a time, once daily) in both eyes.
|
|---|---|---|
|
Eye disorders
Ocular hyperaemia
|
7.3%
6/82 • Week 0(Baseline) and Week 4(End of Study)
|
1.2%
1/84 • Week 0(Baseline) and Week 4(End of Study)
|
|
Eye disorders
Conjunctival hyperaemia
|
6.1%
5/82 • Week 0(Baseline) and Week 4(End of Study)
|
1.2%
1/84 • Week 0(Baseline) and Week 4(End of Study)
|
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