Open Angle Glaucoma or Ocular Hypertension
Conditions
Brief summary
Safety and IOP (intraocular pressure) lowering effect of DE-111 ophthalmic solution will be evaluated in open-angle glaucoma or ocular hypertension patients, in an open-label, multicenter study.
Interventions
Sponsors
Santen Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Inclusion criteria
* Diagnosed with open angle glaucoma or ocular hypertension * Provided signed, written informed consent * 20 years of age and older * If a subject is a female of childbearing potential, she must utilize reliable contraceptive throughout the study, and must have a negative urine pregnancy test prior to enrollment into this study
Exclusion criteria
* Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception. * Presence of any abnormality or significant illness that could be expected to interfere with the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change From Baseline in IOP (Intraocular Pressure) at End of Study | Treatment period: Week 0 (Baseline) and Week 52 (End of Study) |
Countries
Japan
Participant flow
Pre-assignment details
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 .
Participants by arm
| Arm | Count |
|---|---|
| DE-111 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% . | 136 |
| Total | 136 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| 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
| Characteristic | DE-111 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 74 Participants |
| Age, Categorical Between 18 and 65 years | 62 Participants |
| Age, Continuous | 64.0 years STANDARD_DEVIATION 12 |
| Region of Enrollment Japan | 136 participants |
| Sex: Female, Male Female | 81 Participants |
| Sex: Female, Male Male | 55 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 68 / 136 |
| serious Total, serious adverse events | 6 / 136 |
Outcome results
Primary
Change From Baseline in IOP (Intraocular Pressure) at End of Study
Time frame: Treatment period: Week 0 (Baseline) and Week 52 (End of Study)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DE-111 | Change From Baseline in IOP (Intraocular Pressure) at End of Study | -1.8 mmHg | Standard Deviation 2.2 |