Trial Outcomes & Findings for DE-111 Ophthalmic Solution in Patients With Open Angle Glaucoma or Ocular Hypertension (NCT NCT01343082)
NCT ID: NCT01343082
Last Updated: 2015-06-15
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
148 participants
Primary outcome timeframe
Treatment period: Week 0 (Baseline) and Week 52 (End of Study)
Results posted on
2015-06-15
Participant Flow
The run-in period of 4 weeks. Switched to DE-111 ophthalmic solution from Tafluprost ophthalmic solution 0.0015%, Timolol ophthalmic solution 0.5%, or concomitant Tafluprost ophthalmic solution 0.0015% plus Timolol ophthalmic solution 0.5% . Treatment period: 52 weeks .
Participant milestones
| Measure |
Allocated to Tafluprost
Switched to DE-111 ophthalmic solution (one drop at a time, once daily, bilateral topical instillation) from Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily, bilateral topical instillation) .
|
Allocated to Timolol
Switched to DE-111 ophthalmic solution (one drop at a time, once daily, bilateral topical instillation) from Timolol ophthalmic solution 0.5% (one drop at a time, BID, bilateral topical instillation).
|
Allocated to Tafluprost + Timolol
Switched to DE-111 ophthalmic solution (one drop at a time, once daily, bilateral topical instillation) from concomitant Tafluprost ophthalmic solution 0.0015% plus Timolol ophthalmic solution 0.5%.
|
|---|---|---|---|
|
The run-in Period
STARTED
|
51
|
49
|
48
|
|
The run-in Period
COMPLETED
|
48
|
45
|
43
|
|
The run-in Period
NOT COMPLETED
|
3
|
4
|
5
|
|
Treatment Period , Switched to DE-111
STARTED
|
48
|
45
|
43
|
|
Treatment Period , Switched to DE-111
COMPLETED
|
43
|
36
|
31
|
|
Treatment Period , Switched to DE-111
NOT COMPLETED
|
5
|
9
|
12
|
Reasons for withdrawal
| Measure |
Allocated to Tafluprost
Switched to DE-111 ophthalmic solution (one drop at a time, once daily, bilateral topical instillation) from Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily, bilateral topical instillation) .
|
Allocated to Timolol
Switched to DE-111 ophthalmic solution (one drop at a time, once daily, bilateral topical instillation) from Timolol ophthalmic solution 0.5% (one drop at a time, BID, bilateral topical instillation).
|
Allocated to Tafluprost + Timolol
Switched to DE-111 ophthalmic solution (one drop at a time, once daily, bilateral topical instillation) from concomitant Tafluprost ophthalmic solution 0.0015% plus Timolol ophthalmic solution 0.5%.
|
|---|---|---|---|
|
The run-in Period
Not meeting criteria
|
3
|
4
|
5
|
|
Treatment Period , Switched to DE-111
Adverse Event
|
1
|
4
|
3
|
|
Treatment Period , Switched to DE-111
Lack of Efficacy
|
0
|
1
|
2
|
|
Treatment Period , Switched to DE-111
Physician Decision
|
0
|
2
|
2
|
|
Treatment Period , Switched to DE-111
Withdrawal by Subject
|
4
|
2
|
5
|
Baseline Characteristics
DE-111 Ophthalmic Solution in Patients With Open Angle Glaucoma or Ocular Hypertension
Baseline characteristics by cohort
| Measure |
DE-111
n=136 Participants
Switched to DE-111 ophthalmic solution (one drop at a time, once daily, bilateral topical instillation) from Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily, bilateral topical instillation), Timolol ophthalmic solution 0.5% (one drop at a time, BID, bilateral topical instillation), or concomitant Tafluprost ophthalmic solution 0.0015% plus Timolol ophthalmic solution 0.5% .
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
62 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
74 Participants
n=5 Participants
|
|
Age, Continuous
|
64.0 years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
81 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
136 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Treatment period: Week 0 (Baseline) and Week 52 (End of Study)Outcome measures
| Measure |
DE-111
n=136 Participants
Switched to DE-111 ophthalmic solution (one drop at a time, once daily, bilateral topical instillation) from Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily, bilateral topical instillation), Timolol ophthalmic solution 0.5% (one drop at a time, BID, bilateral topical instillation), or concomitant Tafluprost ophthalmic solution 0.0015% plus Timolol ophthalmic solution 0.5% .
|
|---|---|
|
Change From Baseline in IOP (Intraocular Pressure) at End of Study
|
-1.8 mmHg
Standard Deviation 2.2
|
Adverse Events
DE-111
Serious events: 6 serious events
Other events: 68 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DE-111
n=136 participants at risk
Switched to DE-111 ophthalmic solution (one drop at a time, once daily, bilateral topical instillation) from Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily, bilateral topical instillation), Timolol ophthalmic solution 0.5% (one drop at a time, BID, bilateral topical instillation), or concomitant Tafluprost ophthalmic solution 0.0015% plus Timolol ophthalmic solution 0.5% .
|
|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.74%
1/136 • Treatment period: Week 0 (Baseline) and Week 52 (End of Study)
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.74%
1/136 • Treatment period: Week 0 (Baseline) and Week 52 (End of Study)
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.74%
1/136 • Treatment period: Week 0 (Baseline) and Week 52 (End of Study)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.74%
1/136 • Treatment period: Week 0 (Baseline) and Week 52 (End of Study)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer stage unspecified
|
0.74%
1/136 • Treatment period: Week 0 (Baseline) and Week 52 (End of Study)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.74%
1/136 • Treatment period: Week 0 (Baseline) and Week 52 (End of Study)
|
Other adverse events
| Measure |
DE-111
n=136 participants at risk
Switched to DE-111 ophthalmic solution (one drop at a time, once daily, bilateral topical instillation) from Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily, bilateral topical instillation), Timolol ophthalmic solution 0.5% (one drop at a time, BID, bilateral topical instillation), or concomitant Tafluprost ophthalmic solution 0.0015% plus Timolol ophthalmic solution 0.5% .
|
|---|---|
|
Eye disorders
Blepharal pigmentation
|
6.6%
9/136 • Treatment period: Week 0 (Baseline) and Week 52 (End of Study)
|
|
Eye disorders
Growth of eyelashes
|
24.3%
33/136 • Treatment period: Week 0 (Baseline) and Week 52 (End of Study)
|
|
Eye disorders
Punctate keratitis
|
11.0%
15/136 • Treatment period: Week 0 (Baseline) and Week 52 (End of Study)
|
|
Eye disorders
Conjunctival hyperaemia
|
9.6%
13/136 • Treatment period: Week 0 (Baseline) and Week 52 (End of Study)
|
|
Eye disorders
Nasopharyngitis
|
14.0%
19/136 • Treatment period: Week 0 (Baseline) and Week 52 (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